Rosiglitazone remains but experts debate withdrawal
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have thrown a lifeline to diabetes drug rosiglitazone as experts continue to debate whether the drug should be withdrawn.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 Australians “and falling” are taking rosiglitazone, according to the TGA.
Professor Duncan Topliss, director of endocrinology and diabetes at Alfred Health and former chair of the TGA’s Adverse Drug Reactions Advisory Committee, said rosiglitazone should be withdrawn and ongoing trials of the drug stopped.
“On the balance of probabilities, I don’t think this drug should be prescribed. It’s already got pretty tight restrictions in Australia… I’m not sure what additional restrictions you could place on it that would leave it on the market.”
The FDA meeting was preceded by claims in The New York Times that an unfavourable rosiglitazone trial was buried in 2001 by manufacturer Glaxo-SmithKline. In Australia, independent Senator Nick Xenophon even called for executives to face jail for suppressing data.
However, Dr Camilla Chong, GSK’s medical director for Australasia, said the company had consistently acted in a responsible manner and made all its data available to regulators.
Queensland cardiologist Associate Professor David Colquhoun said the safety question would be unanswered until completion of the TIDE trial, which compares rosiglitazone to pioglitazone.
Professor Emily Banks, chair of the TGA’s advisory committee on medicine safety, said it was awaiting the FDA’s final report.