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The following articles have the tag TGA
THE Australian Vaccination Network (AVN) has for the second time been ordered to remove misleading claims from an advertisement on its website for black salve, an unregistered treatment the AVN claimed could cure cancer.
COMPLEMENTARY medicine makers are listing products as foods to avoid stricter Therapeutic Goods Administration (TGA) criteria, with regulatory concerns lost in the “black hole” of state-based food regulators, according to a public health campaigner.
A DECISION to roll out free HIV point-of-care testing in Queensland before confusion over TGA restrictions is clarified could lead to increased transmission, pathologists warn.
A DECISION to roll out free HIV point-of-care testing in Queensland before confusion over TGA restrictions is clarified could lead to increased transmission, pathologists warn.
ADVERSE events resulting from the use of a sports supplement continued to occur after the stimulant was banned by the TGA last year, according to a letter published in the Medical Journal of Australia.
WHAT made the news 10 years ago, and how things have changed (or not).
AN EARLY warning system for safety concerns about medicines and medical devices based on the US Food and Drug Administration (FDA) model is being planned for Australia and New Zealand.
THE TGA has issued an alert on GSK’s influenza vaccine Fluarix after “glass-like material” was found in the syringe vial.
THE TGA has issued an alert on GSK’s influenza vaccine Fluarix after “glass-like material” was found in the syringe vial.
THE TGA has issued an alert on GSK’s influenza vaccine Fluarix after “glass-like material” was found in the syringe vial.
CONFUSION reigns over TGA restrictions placed on the first point-of-care test for HIV, leaving it unclear whether GPs can begin using it.
CONSUMER health groups have applauded the federal government for adding two landmark hepatitis C drugs to the PBS, but warned it must improve its subsidy system to make more expensive life-saving drugs accessible.
THE federal government must extend pharmaceutical patents to make up for the increasing amount of time getting regulatory approval, the medicines industry said last week.
THE benefits of dabigatran (Pradaxa) outweigh the risks when it is prescribed appropriately to the right patients, a TGA safety review has concluded, echoing the view of US and European regulators.
THE TGA is considering regulatory action against an unregistered herbal product which its marketers claim enables users to beat smoking addiction almost immediately.
The TGA has warned prescribers of new contraindications and precautions necessary for multiple sclerosis drug fingolimod (Gilenya) in the wake of the death of a US patient last year.
THE TGA has tightened the requirements for sponsors of medicines other than prescription medicines to comply with its revised pharmacovigilance document, including a shorter time frame for reporting a serious adverse reaction.
DOCTORS are calling for action on look-alike and sound-alike medicines and for the names of active ingredients to be displayed more prominently than brand names, amid concerns about patient safety.
THE manufacturer of a range of homeopathic products designed for children – which contain strychnine and arsenic – has won the dubious honour of being included in the latest Shonky Awards.
THE Therapeutic Goods Administration will push the federal government to tighten regulation of compounding pharmacists amid a deadly outbreak of fungal meningitis in the US linked to a compounding chemist.
MORE than 37,000 pills, including diet supplements, erectile dysfunction medication and steroids, have been seized in Melbourne and Brisbane in a crackdown on fake and illegal medicines.
A HOMEOPATH has stood by claims herbal remedies can reduce domestic violence rates after doctors questioned whether there was any credible link between the two.
AUSTRALIAN women who have had surgical mesh implants to repair pelvic organ prolapse may be at risk of serious complications, lawyers say.
More than 37,000 pills, including diet supplements, erectile dysfunction medication and steroids, have been seized in Melbourne and Brisbane in a crackdown on fake and illegal medicines.
THE rift between the federal government and the pharmaceuticals industry over delays putting Pharmaceuticals Benefits Advisory Committee (PBAC)-recommended products on the PBS could soon reopen, with warnings of a “vocal” campaign if two key treatments remain unlisted.
Medical termination of pregnancy is to be available to a wider group of Australian women after the registration of mifepristone and misoprostol by the Therapeutic Goods Administration today.
THE TGA has dismissed suggestions a steady decline in medicines approvals is linked to its evaluation process, instead blaming “global economic conditions”.
The UK drugs regulator has recommended echinacea should not be given to young children due to the risk of allergic reaction.
THE TGA has finalised its review on the use of over-the-counter cough and cold medicines, advising restrictions in children but rejecting calls for the drugs to be up-scheduled.
AN ALTERNATIVE therapy group has removed a number of unregistered herbal supplements – previously promoted on its website – from sale online following MO’s inquiries to the Therapeutic Goods Administration about its efficacy claims.
AN ALTERNATIVE therapy group has removed a number of unregistered herbal supplements – previously promoted on its website – from sale online following MO’s inquiries to the Therapeutic Goods Administration about its efficacy claims.
A LEADING pharmacologist has called on the government to purchase generic brands only, once the patent on the originator drug expires, to improve the low uptake of generic medicines in Australia.
A STIMULANT used in sports supplements has been banned in Australia following an investigation by the TGA.
A WEIGHT loss company that tells customers how many of its pills to take to reverse the effects of certain fatty foods could face having its products delisted after defying a TGA order to remove some claims from its website.
THE Therapeutic Goods Administration (TGA) has accused controversial alternative medicine group Universal Medicine of selling unregistered remedies and launched an urgent investigation into the products “to protect the public”.
A WEIGHT loss company which tells customers how many of its pills to take to reverse the effects of certain fatty foods could face having its products delisted after defying a TGA order to remove some claims from its website.
SYDNEY based weight-loss company Undoit has rejected suggestions from activist Dr Ken Harvey that it has effectively sidestepped a TGA disciplining action regarding its product.
CONTROVERSIAL insomnia drug zolpidem will not be taken off the market by the TGA, despite renewed reports of deaths and bizarre behaviours.
THE TGA has issued a safety alert to health professionals after receiving adverse event reports of medical devices being incorrectly implanted into patients.
AT-RISK children and newborns will not be able to be vaccinated for tuberculosis for a period of time due to a voluntary recall by the manufacturer of BCG vaccine, the TGA announced today.
A BRAF-inhibitor for advanced-stage melanoma now approved by the TGA has been hailed by specialists as the first ‘leap forward’ in treatment in 40 years for a subset of patients.
ADVERTISED claims for the benefits of complementary medicines will come under renewed scrutiny from the TGA as part of a range of reforms designed to “improve community confidence in the safety and quality of these medicines”.
ADVERTISED claims for the benefits of complementary medicines will come under renewed scrutiny from the TGA as part of a range of reforms designed to “improve community confidence in the safety and quality of these medicines”.
DESPITE controversial weight loss company SensaSlim being prepared to destroy the last of its stock after its product was delisted by the TGA, the authority has given the company the all-clear to sell its wares, MO has learned.
PAINKILLERS containing the same active ingredients in the same quantities could be banned from being marketed for different uses, such as 'headache', 'backache' or 'joint pain', under new proposals from the TGA.
DESPITE controversial weight loss company SensaSlim being prepared to destroy the last of its stock after its product was delisted by the TGA, the authority has given the company the all-clear to sell its wares, MO has learned.
Will the proposed TGA rules be the death knell to the CAMs industry?
THE alternative medicines industry and its critics finally agree on something – if tough TGA-drafted rules about proving product claims are adopted by manufacturers, the $5 billion industry will be obliterated.
A HOMEOPATHY website that claims its products are alternatives to vaccination has for six months operated in defiance of orders to comply with the Therapeutic Goods Advertising (TGA) Code.
AUSTRALIANS are being warned against alternative medicine products, known as black salve or red salve, that are being touted as treatments for skin conditions including cancer.
ALTERNATIVE medicines could soon have a rival to the government registration system as a group of academics prepares a database to rate products on the often “partial and incomplete” evidence given to support their efficacy claims.
THE timeframe in which Australian women may have received substandard PIP breast implants has been extended, amid doubts their French maker had “ever” used medical-grade silicone.
THE timeframe in which Australian women may have received substandard PIP breast implants has been extended, amid doubts their French maker had “ever” used medical-grade silicone.
CONSUMERS have been warned not to buy medication online but advocates say cost pressures are forcing more patients to seek cheap substitutes via the internet.
SUPPLIES of human albumin used in burns, trauma and surgical patients will be limited while its manufacture by CSL Ltd undergoes a safety review.
THE TGA has denied that its decision to cancel Doloxene from the Australian Register of Therapeutic Goods had anything to do with the drug’s status as “the most reliable doctor-prescribed end of life drug”.
ACTIVIST and academic Dr Ken Harvey’s latest crusade against a weight loss product has had an unexpected result – the product has become so popular it sold out nationwide in just two days.
DOCTORS should start finding alternatives to dextropropoxyphene-containing painkillers for their patients despite an appeal against the cancellation of two of the analgesics, the TGA says.
A MEDICARE rebate could be established to offer subsidised MRI scans to Australian women with potentially faulty PIP (Poly Implant Prothèse) breast implants.
ACCESS to subsidised HRT has contracted in Australia, while the evidence base detailing its optimal use has grown, the Australasian Menopause Society (AMS) says.
IN ANOTHER blow to the credibility of the French drug regulatory authority reeling from the PIP breast implants scandal, researchers say a diabetes drug used widely for weight loss has killed more than 1000 people.
THE Therapeutic Goods Administration (TGA) is to be hauled before the Senate again, this time over its actions concerning the controversial Poly Implant Prothèse (PIP) breast implants.
AN AHPRA investigation has been launched into attempts by euthanasia advocate Dr Philip Nitschke to import the banned barbiturate Nembutal for a terminally ill patient who took her own life in December.
The TGA’s decision not to routinely remove PIP (Poly Implant Prothese) breast implants in patients without rupture has been questioned further as yet more countries, including Iceland and the Netherlands, back the removal of PIP implants after conflicting reports about the product's safety.
CONTROVERSY continues to reign over the TGA’s decision not to routinely remove PIP (Poly Implant Prothese) breast implants in patients without ruptured implants.
PUBLIC health experts have welcomed the federal government’s establishment of a dedicated information hotline for women worried about potentially unsafe breast implants, but have warned insufficient post-market regulation of medical devices in Australia remains an issue.
THE Therapeutic Goods Administration (TGA) says there is currently no evidence that Australian women who received silicone gel breast implants manufactured by French company Poly Implant Prothèse (PIP) filled with sub-standard silicone are at an increased risk of rupture. The statement was the outcome of an expert panel convened by the TGA on Wednesday in response to global panic over the safety of the implants. While women who have received the implants in other countries including France and Venezuela have been advised to have them routinely removed, the TGA says there is no immediate need for Australian ...
AUSTRALIAN women with silicone gel breast implants manufactured by French company Poly Implant Prothèse (PIP) have been urged to join a national register and undergo tests for rupture as investigations into a possible cancer link continue.
THE TGA will work to improve its “engagement with the community”, establish a new advisory council and toughen penalties for advertising breaches in a sweeping overhaul aimed at broadening its industry focus to include consumers.
THE Therapeutic Goods Administration has strongly defended its handling of SensaSlim – an oral weight loss spray – amid accusations it assured retailers the now delisted product was legal before they invested in it.
THE manufacturer of dextropropoxyphene (DPP) analgesics has vowed to fight a TGA safety decision to axe the products.
THE man who first complained about SensaSlim nine months ago has declared the TGA’s decision to finally strike the weight loss mouth spray off the Therapeutic Goods Register a “small step in the right direction”.
MORE than 1300 complementary medicines face being struck off the therapeutic goods register because their owners have failed to pay annual listing fees – totalling $701,000 – to the Therapeutic Goods Administration (TGA).
THE TGA has issued a safety advisory warning that patients taking the ADHD medication atomoxetine (Strattera, Eli Lilly) require monitoring due to the risk of increased heart rate and blood pressure.
THE TGA has admitted that it knew in 2009 that Fluvax caused higher rates of fever than other trivalent influenza brands but took no action as the side effects were mostly mild or moderate. An article in the MJA online on Monday raised questions about the fact that data from trials that found a high rate of fever were not included in Fluvax product information in 2010 ( MO , 17 October). TGA national manager Dr Rohan Hammett was questioned at a Senate estimates committee hearing yesterday about adverse events in ...
AN EXTERNAL defibrillator is being recalled because it has a fault that could result in failure to restore normal cardiac rhythm, a TGA alert advises. A small number of Meducore Easy Automatic External Defibrillators being recalled cannot be located, distributor Ferno Australia has told the TGA. The defibrillators are being recalled for correction because they have a capacitor charging problem that could potentially result in the device not delivering the required electrical shock to re-establish normal cardiac rhythm. The company says the defibrillators can be corrected by updating the device’s ...
THE Therapeutic Goods Administration has moved to reassure Australian travellers that new millimetre-wave body scanning equipment being trialled at Melbourne International Airport is safe. In a statement released this week the TGA indicated there were no known safety concerns for people with active implantable medical devices, including pacemakers and defibrillators, when passing through the scanners. Trials of the technology at Sydney International Airport has moved to Melbourne this month as part of a proof of concept trial, which will last until the end of the month. According to the Federal ...
THE Therapeutic Goods Administration (TGA) has confirmed it will consider labelling complementary medicines with a warning to consumers the products have not been tested for efficacy. Responding to last week’s Australian National Audit Office (ANAO) review of the regulation of complementary medicines, a TGA spokesperson said the administration was “supportive of moves to inform the community that low risk, complementary medicines are not tested by the TGA for efficacy”. The audit office review found the TGA’s approach to “easy, quick and low cost” market access for sponsors of complementary medicines was abused by ...
THE Therapeutic Goods Administration (TGA) is “actively considering” whether to de-list weight loss product SensaSlim Solution. The move comes as the TGA’s complaints resolution panel continues to monitor a $1 million defamation suit lodged by SensaSlim director Peter O’Brien against academic and activist, Dr Ken Harvey. The suit is the second defamation action brought against Dr Harvey over the contents of complaints he made to the panel about advertisements for SensaSlim Solution. The first action, an $800,000 claim on behalf of the company lodged with the NSW Supreme Court in June, was finalised last week when ...
ACTIVIST Dr Ken Harvey has won a two-month battle to avoid an $800,000 defamation action from weight-loss company SensaSlim but now faces a $1,075,000 claim from company director Peter O’Brien. Administrators for SensaSlim’s Australian business did not oppose an application from Dr Harvey’s lawyers in the NSW Supreme Court today to dismiss the defamation claim against the company, which was based on a series of complaints he made to the TGA about a SensaSlim product. Dr Harvey said he was relieved to have the case dismissed and costs awarded against SensaSlim, but was ...
EUTHANASIA advocate Dr Philip Nitschke has applied to the TGA to access the banned drug Nembutal on behalf of six terminally ill patients who want to use it as a sedative. The barbiturate, available for sale in Australia during the 1950s as a sleeping tablet, is the premier euthanasia drug used in the Netherlands and Switzerland for patients seeking to end their lives. In March, a directive from the Australian Customs and Border Protection Service warned patients against importation of Nembutal, manufactured in the US, but indicated doctors could apply on their ...
WARNINGS on the use of antipsychotics during the third trimester of pregnancy are being updated on labels of all drugs in this category, the TGA says. Product information (PI) will now warn about the risk of neonatal extrapyramidal signs (EPS), such as dyskinetic movements, and withdrawal symptoms. Up to May 2011, the TGA had received 19 reports of EPS or withdrawal symptoms in neonates, with an atypical antipsychotic suspected in 18 reports, the regulator said in a Medicines Safety Update. Many cases were confounded by concomitant use of other psychotropic medication, but ...
For decades, Dr Ken Harvey has advocated evidence-based medicine. He talks to Mark O’Brien about the risks versus the rewards of his labours.
THE TGA has moved to counter suggestions that nanoparticles in sunscreen may be harmful, ordering a manufacturer to drop promotional material referring to a “nano free” product. The TGA argues that promotions of Invisible Zinc sunscreen as “not nano” and “nano free” could imply sunscreens containing nanoparticles were unsafe. The sunscreen, promoted by Elle Macpherson, is depicted as free from nano-grade zinc oxide and titanium dioxide, which some researchers have suggested may pose health risks. A TGA spokeswoman said the matter had been considered under the advertising provisions in the Therapeutic Goods Act and the company ...
THE TGA has issued a safety advisory for pioglitazone (Actos) following research linking long-term use to an increased risk of bladder cancer. A US study found patients with type 2 diabetes taking the medication for more than 24 months had 1.4 times the cancer risk of patients not taking it. A preliminary assessment of data from a French trial also showed an increased risk of bladder cancer in patients taking the drug for more than 12 months, the TGA said. “The TGA is advising health professionals and consumers that use of the diabetes medicine, pioglitazone, for ...
THE TGA has issued an urgent recall for a medical kit because the thermometer in it displays the temperature reading in degrees Fahrenheit rather than Celsius. The product, Safety 1st Complete Healthcare Kit, is in a white nylon case with blue and orange flowers and has been sold through Kmart, Toys R Us, Target and other retailers over the past three months. “If the person reading the temperature display is not aware that the reading is in degrees Fahrenheit they may unnecessarily seek treatment for a high temperature,” the TGA warning said. The recalled kits, supplied ...
A FAULTY blood glucose measuring device has been urgently recalled by the TGA. The TGA website has posted a warning for the LifeScan OneTouch Verio blood glucose monitoring system, which reportedly gives repeated ‘error 2’ warning messages when used in high temperatures or humidity due to contamination of a component. The device recall is classified as a Class II defect, meaning it could cause illness or mistreatment, but is not potentially life-threatening. Since May this year LifeScan, the manufacturer of the device, had received 179 complaints from Australia relating to the ‘error 2’ message. A ...
A “100% herbal” medication that promises to improve a woman’s sex life has been found to contain the active ingredient tadalafil. The Therapeutic Goods Administration (TGA) has issued a public warning recommending against the use of Pink Lady for Women capsules, sold via the Internet, as they may pose a health risk. “In Australia, commercial supply of Pink Lady for Women capsules is illegal,” the TGA said on its website. While the product label claims the ingredients to be herbal in origin, “analysis undertaken by the TGA Laboratories in Australia has confirmed the presence of therapeutic ...
THE TGA is investigating whether there is a link between angiotensin receptor blockers (ARBs) and cancer, following recent studies showing patients taking ARBs had a small increased risk of the disease. A spokesperson for the TGA confirmed the organisation was conducting its own evaluation of the evidence and had not offered specific advice on the use of ARBs and potential cancer risk. Last week the US Food and Drug Administration (FDA) announced that ARBs do not increase cancer risk, following the results of an analysis of 31 randomised controlled trials of more than 150,000 patients taking ARBs ...
THE TGA has issued a medicines safety update for PPIs, warning of the risk to patients of hypomagnesaemia and other life-threatening events, pointing to an advisory released by the US Food and Drug Administration in March. “A recent international safety advisory has warned of a potential association between prolonged use of PPIs and serious hypomagnesaemia-related adverse events such as tetany, seizures, delirium and cardiac arrhythmias,” the TGA said. “While this occurs rarely, prescribers should be vigilant to PPI-associated hypomagnesaemia [and] patients presenting with hypomagnesaemia may require PPI discontinuation.” Two Australian cases of low magnesium levels linked ...
THE smartphone market represents a challenge of “enormous complexity” for regulators, the TGA has acknowledged amid belated moves to tackle the explosion in health- and medical-related apps. The TGA is part of a push to improve the oversight of therapeutic-related apps headed by the Global Harmonization Task Force (GHTF), a body set up to standardise the regulation of medical devices across member countries. A TGA spokesperson said work was ongoing with the GHTF to introduce a “harmonised approach” to the oversight of apps among members, which include the US, Japan, Canada and European nations. “The report ...
GPs are urged to not administer a second dose of Pneumovax 23 to any patient, as the TGA investigates a surge in adverse reactions to the vaccine. The TGA has received 178 adverse reaction reports for the vaccine so far this year, to 14 April. That was about three times the number recorded over the same period last year (63 adverse reactions) and a fivefold increase over 2009 (34). The Merck Sharp & Dohme-manufactured vaccine is provided under the National Immunisation Program for those people older than 65 years, Indigenous Australians over 50, smokers and those ...
THE TGA has been urged to step up regulation of herbal remedies, along with public awareness campaigns on the dangers of buying products online, after a man died from renal failure linked to a herbal treatment. The call comes as naturopaths and herbalists seek registered health practitioner status under AHPRA. But Dr Brian Morton, chair of the AMA’s Council of General Practice, said the case was further evidence against the push. “It’s not evidence-based [medicine], and until it adopts a scientific and evidence-based approach, it will always be fringe,” he said. Writing in the MJA, ...
PHARMACEUTICAL companies are under pressure to monitor their sales representatives, after new research revealed a visit to a GP is becoming a growing marketing tool in Australia. The research, from Cegedim Strategic Data, showed spending on pharmaceutical rep meetings with GPs rose by 9.3% to $47.7 million from 2009 to 2010. The increase came as the entire pharmaceutical industry spending on marketing – including detailing, mailing, print advertising and samples – rose by 9% to $353.5 million. Dr Ken Harvey, adjunct senior lecturer at La Trobe University’s School of Public Health, said pharmaceutical companies monitored all ...
STRICT guidelines will govern paediatric influenza vaccination this year, with immunisation providers advised to use only two of the six registered vaccines for children younger than 10 years. Only Influvac (Abbott) and Vaxigrip (Sanofi Pasteur) can be used in children aged under five years, the TGA said.And the Australian Technical Advisory Group on Immunisation (ATAGI) had a “strong preference” that these trivalent seasonal flu vaccines be used up to the age of 10 years. Fluvax (CSL), linked to a ninefold higher than expected rate of febrile convulsions (one in 100) in young children in 2010, has not ...
THE TGA has confirmed an increased risk of intussusception (IS) in children in the week following receipt of rotavirus vaccine. While the manufacturers of both Rotarix (GSK) and RotaTeq (Merck, CSL) will amend product information to reflect the increased risk, Australia's vaccination program will not change, the TGA said. "The TGA considers that the overall risk benefit balance of both vaccines remains positive," a report on its website said. Immediate comment was not available from the vaccine manufacturers. The TGA said an investigation of 274 cases of IS from three states (NSW, Victoria and Western ...
THE director of a hair regrowth company has been banned from selling prescription and pharmacy-only medication to his clients following an investigation by the NSW Health Care Complaints Commission (HCCC). The investigation found that Samuel Cohen, director of the Institute of Hair Regrowth and Beauty, had supplied clients with medication obtained from other clients’ prescriptions. The investigation was launched following a complaint to the HCCC from one of Mr Cohen’s clients that he had paid $3,700 for a hair regrowth treatment program that resulted in an allergic reaction. ...
The Therapeutic Goods Administration (TGA) has come under fire from consumers who argue the regulatory body’s operations suggest it represents the interests of the therapeutics industry and not consumers. In a submission to an ongoing review into the transparency of the TGA’s operations, the Consumers Health Forum of Australia (CHF) has claimed that the TGA’s funding, sourced entirely from drug manufacturers, presents a potential conflict of interest for the regulator. Carol Bennett, chief executive officer of the CHF, said government funding was needed to ensure any conflict of interest was negated. “Ideally there would be, as ...
AT LEAST four Australian women may have developed a rare cancer as a result of having breast implants, a US government review shows. The US Food and Drug Administration (FDA) yesterday announced a possible link between anaplastic large cell lymphoma (ALCL) and saline- or silicone-filled breast implants. Data from its review suggests patients with breast implants may have a very small but significant risk of ALCL in the scar capsule next to the implant. The FDA review, which included scientific literature from the past 13 years, found 34 unique cases of ALCL in women who had ...
LONG-OVERDUE reforms to regulatory framework for medical devices may soon be underway, with the TGA calling for public comment on a new reform discussion paper. A series of public consultations will be held in November, as the agency responds to mounting criticism and a worldwide clamour to tighten device approval processes. Online and written submissions are also invited during the consultation period, which closes on 17 December. The announcement comes as a BMJ investigation found the US Food and Drug Administration (FDA) had little oversight of safety studies, and that manufacturers often failed to conduct them properly. One ...
THE TGA has blamed this year’s paediatric influenza vaccination debacle on the overzealous approach of West Australian health authorities. In an apparent bid to deflect criticism from the Commonwealth’s handling of the high rate of febrile convulsions linked to Fluvax, a TGA report has criticised WA for setting up a program “outside national immunisation guidelines”. In its first official response to the August WA ministerial review authored by Professor Bryant Stokes, the TGA takes repeated swipes at the WA program, calling it a “trial” that had been set up without appropriate safety considerations. “There is a ...
THE weight-loss drug sibutramine (Reductil) has been withdrawn from the Australian market after research linked it to an increased risk of cardiovascular events, raising new questions over medication-based weight loss. The withdrawal, announced late last Friday, followed an analysis of the SCOUT study of almost 10,000 patients, which showed an increased risk of serious, non-fatal cardiovascular events in patients taking sibutramine after six years. “Analysis of the final results… have since confirmed there is an increased risk of major cardiac events such as heart attack and stroke in obese and overweight patients taking sibutramine,” the TGA said ...
The TGA is examining post-marketing surveillance data after US regulators raised concerns about a link between the rotavirus vaccine Rotarix and the risk of intussusception. The US Food and Drug Administration last week ordered changes to Rotarix’s warning label after an analysis of interim data from a Mexican study showed a greater risk of intussusception in the four weeks following the first dose. A spokeswoman for the vaccine’s manufacturer, GlaxoSmithKline, said the company had shared with regulators interim data showing a “small, temporal” increased risk after the first dose of Rotarix compared to the risk of intussusception ...
GPs should not use any stocks of the paediatric pandemic vaccine as it has lost potency, the TGA says. The TGA said the manufacturer, CSL, would be recalling from immunisation providers all stocks of Panvax H1N1 2009 Junior, which is supplied in 0.25 mL pre-filled syringes. Stability testing showed the vaccine had declined in potency and could no longer be expected to produce an effective immunological response, the TGA said. “The TGA has informed CSL that Panvax Junior’s registered 12-month shelf life can no longer be supported and the shelf life has been reduced to six ...
MANY consumers and clinicians may be unaware that a combination of paracetamol and caffeine is on sale in pharmacies. Panadol Extra, which became an S2 Pharmacy Medicine on 1 May this year, contains 65 mg of caffeine per tablet. However, the NPS believes “people may not be aware from the brand name that this preparation contains caffeine”. The report warned that unwitting consumption of caffeine in Panadol Extra by pregnant women could take them over the recommended daily level of no more than 200 mg of caffeine per day. The NPS also said the extent ...
THE TGA has broken new ground by evaluating and registering a herbal medicine, via a new registration pathway for complementary medicines. The new product, Iberogast (STW 5) Oral Liquid, manufactured by Flordis, has been approved for the treatment of functional dyspepsia and irritable bowel syndrome (IBS). It contains nine active ingredients, each a herbal liquid extract. As part of its claim, Flordis provided data from five randomised controlled trials, involving a total of 45,000 patients. Two of the trials found the product was efficacious beyond its stated shelf life of 24 months. Almost all TGA-registered ...
US regulators have thrown a lifeline to diabetes drug rosiglitazone as experts continue to debate whether the drug should be withdrawn. Members of a US Food and Drug Administration (FDA) advisory committee last week voted to keep the drug on the market. Twelve of the 33 members recommended withdrawal; 10 voted to restrict sales and accentuate label warnings; seven voted for tighter warnings only; three voted for no changes; and one abstained. Several recent studies have linked rosiglitazone to increased risks of adverse cardiovascular outcomes and mortality, although other findings have conflicted. At most, 20,000 ...
SAFETY regulators have issued a warning about a herbal weight loss pill that contains a dangerous cocktail of stimulants, beta blockers and sibutramine. The product – Que She – could cause serious side-effects, especially in those with cardiovascular conditions, the US Food and Drug Administration (FDA) said this morning. Que She, marketed as “Slimming Factor Capsule” or “an all-natural blend of Chinese herbs”, was found to contain fenfluramine, ephedrine, propanalol and sibutramine. A spokesperson for the TGA reiterated warnings about the dangers of purchasing medicines over the Internet, as they had usually not been tested by ...
TOUGHER regulation of the therapeutic goods industry is on the horizon with the Federal Government now pushing for a universal advertising code and more teeth for the TGA to deal with offenders. Parliamentary Secretary for Health Mark Butler last week released a position paper warning the industry to get tough on poor advertising practices by 2012 or potentially face a federally-enforced code of conduct. Medicines Australia and the Generic Medicines Industry Association applauded the call but did not comment on whether they would review their codes. Dr Ken Harvey, senior research fellow at La Trobe University, ...
INFLUENZA vaccine maker CSL has deviated from good manufacturing practice at its Australian facility, US authorities claim. While no patients have been endangered, the US Food and Drug Administration (FDA) has queried components used in prefilled syringes and swine flu multi-dose vials (MDV). The FDA has demanded CSL explain and correct its non-compliance with good manufacturing practice. CSL had used rubber stoppers on its multidose vials (MDV) despite being notified by the supplier that they were not recommended for use with thiomersal containing products, the FDA said in a letter to CSL. The letter, released on ...
TOUGHER regulation of the therapeutic goods industry is on the horizon with the Federal Government now pushing for a universal advertising code and more teeth for the TGA to deal with offenders. Parliamentary Secretary for Health Mark Butler last week released a position paper warning the industry to get tough on poor advertising practices by 2012 or potentially face a federally-enforced code of conduct. Medicines Australia and the Generic Medicines Industry Associ-ation applauded the call but did not comment on whether they would review their codes. Dr Ken Harvey, senior research fellow at La Trobe University, ...
THERE is no longer any clinical justification for prescribing rosiglitazone and ongoing trials of the drug should stop immediately, a leading expert believes, following the release of new evidence. Professor Duncan Topliss, former chair of the TGA’s Adverse Drug Reactions Advisory Committee, said, based on current evidence, rosiglitazone would never have been registered. His comments follow publication of new observational data from the US Food and Drug Administration linking the drug to an increased risk of heart failure, stroke and all-cause mortality compared with pioglitazone. An updated meta-analysis also showed an increased risk for myocardial infarction ...
QUESTIONS have been raised over the integrity of the medicines supply chain after a batch of counterfeit Viagra (sildenafil) was discovered in a number of pharmacies across NSW, Victoria and the ACT. The product, to which Pfizer is the sole authorised manufacturer and supplier, is believed to have entered the supply chain after wholesaler Symbion Pharmacy Services sourced the product from an independent NSW wholesaler. It is unclear why Symbion did not source the product directly from Pfizer. “It is normal procedure to source the product directly from Pfizer... Symbion has immediately reviewed its procedures to ensure ...
DRUG regulators have done little to strengthen adverse event surveillance since the rofecoxib scandal, a leading medical ethicist argues. Dr Nik Zeps, a member of the NHMRC’s Australian Health Ethics Committee, said there had ultimately been no major changes to post-marketing surveillance since the drug’s controversial withdrawal in 2004. His comments follow the publication of a meta-analysis of data from tens of thousands of patients, linking angiotensin-receptor blockers to an increased risk of cancer (MO, 18 June). An editorial by prominent US cardiologist Dr Steven Nissen described the findings as “disturbing and provocative”, calling on regulators ...
The TGA should widen its net and test medicines sold online to combat substandard and counterfeit medications, pharmacists have argued. The call from the Pharmaceutical Society of Australia (PSA) follows the release of a South Korean study that revealed life-threatening mixtures of toxic materials in counterfeit erectile dysfunction medications, all of which were available online. “The issue of counterfeit drugs... rages around the rest of the world to a fairly enormous degree, and we don’t seem either aware or prepared for the issue of counterfeit drugs,” said PSA president Warwick Plunkett. “One way to make people ...
Plans to curb the availability of compounded preparations to treat menopause and impotence appear to have been ditched by a Government advisory committee. Menopause specialists, who recently revealed the first suspected death linked to bioidentical hormone use, say the move is a “cop-out”.Professor Alastair MacLennan, head of obstetrics and gynaecology at the Women’s and Children’s Hospital, Adelaide, said a quarter of HRT used in Australia was now compounded. “If they are not addressing this issue and tightening this... unregulated hormone replacement industry... I believe it’s a cop-out and a great concern.” Endocrinologist Professor Henry Burger, consultant ...
POTENTIALLY dodgy medical devices will face little regulation under new TGA regulations binding in-vitro device manufacturers, an expert has argued. As of 1 July, a new regulatory framework for assessing in-vitro devices will require manufacturers to produce clinical evidence to prove their products meet specific performance levels. Of the four categories under the new framework, class 4 devices face the toughest regulation. But Dr Ken Harvey, senior research fellow at La Trobe University, says devices that fall into class 1 will face virtually no regulation. Shonky medical devices, he argued, would continue to be sold. ...
MDOs are reminding practitioners of their reporting duties, and to ensure patients make informed decisions on seasonal flu vaccinations, following a number of serious adverse reactions.
THE TGA has approved the pneumococcal conjugate vaccine Prevenar 13, its manufacturers Wyeth has announced. Prevenar 13 is indicated for active immunisation for the prevention of diseases caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, in children aged from six weeks up to five years of age. It was the first vaccine to target serotype 19A, an emerging strain of the disease, the Wyeth statement said. The TGA said the approval followed 13 international phase III trials proving its safety and efficacy. The most common ...
Around the world the prevalence of counterfeit drugs is skyrocketing. Kirrilly Burton reports.
MOVES to streamline the approvals processes for new drugs and medical devices will see patients able to access new treatments sooner, according to a Federal Government report.
THE TGA is set to re-examine the safety of rosiglitazone, following a US senate report that has raised new fears about the drug’s cardiovascular risk. The report, released on Saturday, marked the conclusion of a two-year inquiry by the US Committee on Finance, which included a review of internal documents from the drug’s manufacturer GlaxoSmithKline (GSK). Senators accused GSK of downplaying findings that rosiglitazone might increase cardiovascular risk and failing to sufficiently warn patients and regulators. A spokeswoman said the TGA was reviewing the report and awaiting a response ...
IMPROVEMENTS to the regulation of complementary medicine (CAM) are needed to ensure patients with cardiovascular disease are aware of potential side-effects and interactions with their regular medications, experts have warned. They believe at-risk patients will continue to use complementary medicines unless more is done to alert the public of their dangers. Jon Wardle, NHMRC research scholar in the school of population health at the University of Queensland, said current regulatory models for CAM in Australia were woefully insufficient. “There needs to be more regulation and standardisation focused on quality and efficacy as well as the ...
THE TGA is continuing to examine the safety of the weight-loss drug sibutramine (Reductil) as news of its imminent withdrawal in Europe makes headlines. The European Medicines Agency (EMA) last week recommended suspension of marketing authorisation across the EU after its review concluded sibutramine increased the risk of cardiovascular events. The US Food and Drug Administration has requested new restrictions be placed on the drug, while authorities in New Zealand are currently reviewing the data. Both have recommended that the drug be avoided in patients with a history of cardiovascular disease. The TGA circulated a ...
THE TGA has rejected claims in the national media that it advised GPs to stop prescribing the weight loss drug sibutramine (Reductil) based on safety concerns. Reports in weekend newspapers claimed patients were turning to the Internet to order supplies of the drug after the TGA circulated a directive to doctors on Christmas Eve stating new clinical trial evidence had found the drug to be unsafe. However, a spokesperson for the TGA has told MO that while the TGA proposed some added precautions be included in Reductil product information, it did not recommend prescribing restrictions. ...
Before a drug or device can enter the Australian market, it needs TGA approval. Mary Fallon examines the strength of our regulatory fortress. NO-ONE could argue the Therapeutic Goods Administration (TGA) has an easy job. On the one hand, it needs to make timely decisions about whether to allow medicines and medical devices onto the Australian market. On the other, it needs to make sure public safety standards are upheld. It’s a fine line to walk, and national TGA manager Dr Rohan Hammett believes his agency of 550 staff does “a remarkable job” of ...
Will a new scheme forcing pharma companies to pay for PBS listings have a downside for patients, doctors and industry? Pamela Wilson takes a look. WITH one hand the Government giveth, with the other it taketh away. That’s how some health industry experts believe the new PBS cost-recovery plans will work. There’s widespread concern that this legislation, recently passed by Federal Parliament, will increase the cost of medications and impact on the availability of targeted, or orphan, drugs for Australian patients. It works like this: from January, pharmaceutical companies will have to pay ...
THE Therapeutic Goods Administration (TGA) says there are no local safety concerns after a Canadian company that exports medicines to Australia recalled some of its products. Apotex, which provides a wide range of products available on the PBS, issued a recall of 40 of its products in the US and Canada last week after the US Food and Drug Administration (FDA) placed an import ban on medicines produced at two of its manufacturing sites in Toronto. The recall followed the FDA’s finding that Apotex had deviated from acceptable manufacturing processes. The TGA said it was confident ...
NEW TGA measures to improve pharmacovigilance – and ultimately reduce adverse drug reactions – may fall short of their potential due to inadequate resourcing, an academic has claimed. As of next year, the TGA has stipulated that pharmaceutical companies must present postmarketing pharmacovigilance and risk minimisation plans as part of the TGA pre-approval process for a medicine. In some instances, the plan may simply describe routine passive pharmacovigilance activity, but where there are gaps in safety data, it will include proposed studies to overcome the gap. Writing in the current issue of the MJA , ...
The herpes simplex treatment famciclovir could be downscheduled from S4 to S3 prescription if the TGA’s National Drugs and Poisons Schedule Committee agrees to the change. The committee will meet in October to consider amending the schedule for oral famciclovir in divided preparations for treating herpes labialis (cold sores). The committee has also been asked to consider amending 10 mg or lower doses of oral montelukast for treating seasonal allergic rhinitis from prescription to pharmacist-only scheduling. Nabiximols, a botanical extract containing cannabinoids in a buccal spray preparation, will be considered for scheduling as a drug of ...
THE class action against the TGA – sparked by the body’s 2003 decision to recall hundreds of products manufactured by Pan Pharmaceuticals – was due back in the Federal Court this week. The $120 million claim was lodged by PharmaCare Laboratories on behalf of 165 sponsors, customers and creditors of Pan Pharmaceuticals who were affected by the recall. As MO went to press, both parties were expected to attend a direction hearing, where they would receive instructions on submitting evidence. Brett Saunders, of McLachlan Thorpe Partners, the law firm representing PharmaCare Laboratories, told ...
EXPERTS are at odds over whether new moves by Marie Stopes International to provide Queensland women with medical abortion will contravene the state’s outdated laws, and put patients and doctors at risk of prosecution. Fourteen doctors working for Marie Stopes International were last week granted a licence by the Therapeutic Goods Administration to provide the controversial RU-486 abortion drug to women, just two months after Cairns-based gynaecologist and obstetrician Dr Caroline de Costa stopped prescribing it. Dr de Costa – who was the first medical professional in Australia to be granted a licence to prescribe RU-486 – ...
FRESH calls for generic pharmaceutical companies to be forced to comply with the full industry code of conduct have emerged, after generics manufacturer Sigma recently invited GPs to attend a 10-day educational event aboard a six-star cruise ship on the Mediterranean. GPs can attend the event for $7400, which includes conference registration, accommodation and airfares to Rome. The Medicines Australia code of conduct applies to all pharmaceutical companies, however manufacturers of generic drugs must only comply with rules on marketing and advertising. Medicines Australia CEO Ian Chalmers said the event highlighted the double standards for branded ...
AUSTRALIAN regulators are reviewing the safety of widely used smoking cessation products varenicline (Champix) and bupropion (Zyban and generic alternatives) after a number of reports of serious neuropsychiatric symptoms following their use. The US Food and Drug Administration (FDA) recently announced that following analysis of post-marketing adverse events, it would require manufacturers to add black box warnings regarding the risk of suicidal ideation and behaviour in patients with no history of psychiatric illness. The manufacturers are also expected to update prescribing information and patient medication guidelines with similar warnings. To the end of March 2009, the ...
A SWINE flu vaccine may still be many months away, despite the continuing rise in cases, Australia’s first fatalities and the growing threat to vulnerable Indigenous communities. The Therapeutic Goods Administration (TGA) is not commenting on whether the vaccine will be fast-tracked, with the manufacturer’s scheduled trial program due to take six months to complete. While batches of the vaccine could be ready for use in August, little trial data will be available to the TGA by then, CSL spokeswoman Dr Rachel David said. “Given that currently the mortality from the H1N1 [flu] is not high, ...
THE anti-thyroid drug propylthiouracil (PTU) has been linked to liver failure and death, according to the US Food and Drug Administration (FDA). It said to date there had been 12 deaths and five liver transplants in adults, and one death and six transplants in children taking the drug. A spokesperson said the Therapeutic Goods Administration would review the FDA evidence, and that women aged up to 30 years had a higher risk of hepatotoxicity. The manufacturer, Phebra, is reviewing the drug’s product information.
THE Therapeutic Goods Administration (TGA) has dismissed concerns about neurological symptoms following immunisation with Gardasil. In an update on adverse events associated with the vaccine, the TGA said last week that it was aware of a small number of cases in which neurological symptoms similar to those experienced with a demyelinating disorder had been reported shortly after HPV vaccination. However, the incidence was “not demonstrably higher than would be expected to occur by chance”. Among the 1304 suspected adverse reactions reported in Australia following 4.7 million doses of Gardasil, one in five was a psychogenic event ...
FOR many heroin users and their desperate families, the prospect of a quick fix for addiction to this all-consuming drug has been a tantalising reality. Naltrexone implants have been inserted into thousands of Australian heroin users over the past decade, despite serious safety concerns raised by drug treatment agencies around the country. These implants are not registered with the Therapeutic Goods Administration (TGA) and are either produced here or imported from China. Clinics around the country have been inserting these devices – under the TGA Special Access Scheme – by claiming that heroin-dependent patients are critically ill and at risk of death. These ...
PRESSURE on the Therapeutic Goods Administration (TGA) to curb the unscrupulous promotion of complementary weight-loss products is mounting, with leading health groups now agitating for change. In submissions to the regulatory body, health groups such as the Royal Australasian College of Physicians (RACP) and the Public Health Association of Australia (PHAA) have called for complementary weight-loss products to be delisted by the TGA and removed from shelves, unless promoters are able to provide evidence of efficacy. The calls follow recent admissions from Parliamentary Secretary for Health and Ageing Senator Jan McLucas that she held concerns over how ...
A LEADING health policy critic has rejected calls for the complementary medicines industry to be given a central role in the development of the government’s preventive health policy. In an editorial for ABC News online, Complementary Healthcare Council executive director Dr Wendy Morrow (PhD) last week called for the appointment of a “chief complementary healthcare adviser to sit within the Department of Health”. “[We] believe it is highly unlikely that the Government will make significant inroads into the burden of disease (and the associated national healthcare expenditure impost) without broader consideration of the value of complementary medicines,” ...
UNSCRUPULOUS advertisers of complementary medicines may come under tighter control with an overhaul of the enforcement of the Therapeutic Goods Advertising code. Senator Jan McLucas, Parliamentary Secretary for Health and Ageing, told MO she was concerned enforcement of the code – including the Therapeutic Goods Administration’s (TGA) complaints resolution panel – was not “working efficiently and effectively.” “I have asked the TGA to prepare advice on possible changes,” she said. “Preliminary discussions have taken place with the Therapeutic Goods Advice Council.” The senator expressed her concerns following a special meeting with Dr Ken Harvey, ...
DETAILS remain sketchy on the structure and remit of the new body set to replace the Adverse Drug Reactions Advisory Committee (ADRAC) next year, with critics questioning the benefit of the changes. The TGA recently announced that ADRAC would be replaced by a new “Medicines Safety Committee” ( Medical Observer , 21 November ). It would have additional functions to oversee, assess and review risk management plans of sponsors in relation to the post-market safety of medicines, according to an official statement. Dr Ken Harvey, a La Trobe University public health policy expert, said the changes ...
INCREASED transparency and more drug information will be the remit for a new Therapeutic Goods Administration (TGA) committee to replace the much-criticised Adverse Drug Reactions Advisory Committee. The Medicines Safety Committee will take a “whole-of-lifecycle” approach to pharmacovigilance, and will be headed by a pharmaceutical company-appointed person who will oversee the post-marketing safety of medicines. The membership of all the TGA’s statutory committees will also change to include “a person with expertise in consumer issues”. No such role currently exists. Other changes include increasing the amount of publicly available information throughout the regulatory process, as well ...
CALLS for greater transparency within the Therapeutic Goods Administration (TGA) have been renewed by a leading academic, who has labelled the organisation as being among the “most secret” regulation agencies in the world. According to Dr Agnes Vitry (PhD), senior research fellow at the University of South Australia’s Division of Health Sciences, recent studies demonstrated that UK, European and even US authorities were more transparent, despite contending with more powerful pharmaceutical industries. In particular, Dr Vitry held up the US Food and Drug Administration as a model of best practice, noting meeting minutes and information on new ...
AS businesses and shareholders affected by the 2003 Pan Pharmaceuticals recall line up to be part of a class action against the Therapeutic Goods Administration (TGA), the government has ruled out an inquiry into the inner workings of the organisation. The new development follows last week’s $50 million government payout to Pan Pharmaceuticals founder Jim Selim, who claimed the organisation had acted illegally in 2003 when it recalled the company’s products and suspended its licence. Complementary Healthcare Council executive director Dr Wendy Morrow (PhD) met with Senator Jan McLucas, the parliamentary secretary for health and ageing, last ...
A PROPOSAL to allow GPs to prescribe isotretinoin (Roaccutane) for severe acne has met resistance from dermatologists who say the move could lead to birth defects, abortions and suicides. The TGA’s National Drugs and Poisons Schedule Committee will consider in October a proposal to extend prescribing of isotretinoin from dermatologists and specialist physicians to GPs. The Australasian College of Dermatologists will oppose the proposal, honorary secretary Dr Stephen Shumack said. “It’s a recipe for disaster because isotretinoin should be a last resort, but there could be lots of leakage to acne which isn’t severe and resistant, ...
PAN Pharmaceuticals former chief executive Jim Selim has won $55 million from the federal government after it chose to settle a claim that could have seen taxpayers part with more than $230 million. In 2003, Mr Selim’s company collapsed when the Therapeutic Goods Administration (TGA) recalled 219 of Pan’s products and suspended its manufacturing licence. The moves came after more than 100 people suffered side-effects, including severe hallucinations, from taking Pan’s travel sickness drug Travacalm. Despite the settlement, the government has not conceded Mr Selim’s claims that the TGA acted negligently and outside the limits of its statutory powers.