- FDA to allow dispensing of GSK's Type 2 diabetes drug Avandia in retail pharmacies again
- Senate passes Drug Quality and Security Act
- Crossmark names Janet Carter-Smith VP
- 21 health industry groups address FDA on proposed changes to generic drug label rules
- FDA approves combination of two GSK drugs for skin cancer
LONDON — With respect to the Type 2 diabetes drug Avandia, British drug maker GlaxoSmithKline has another medical study to worry about.
Publishing results online in the British Medical Journal on Thursday, researchers at the University of East Anglia in the United Kingdom and Johns Hopkins University performed a review and analysis of 16 observational studies of a total of 810,000 patients using the drug, known generically as rosiglitazone, to assess their risk of heart attack, compared with those using Takeda’s Actos (pioglitazone). They found that patients using Avandia had a significantly higher risk of heart attacks, heart failure and death. Both drugs belong to the same class, known as thiazolidinediones, which work by targeting insulin resistance.
In response to studies indicating that use of Avandia could increase the risk of heart problems, the Food and Drug Administration placed restrictions on its use in September 2010. The agency also required GSK to create a risk evaluation and mitigation strategy, or REMS, for the drug, allowing its use when patients can’t control their blood-glucose levels with Actos.
But Actos might not be totally off the hook, either. On Friday, the European Medicines Agency announced it would investigate evidence linking the drug to bladder cancer in some patients. The FDA began its own review of Actos in September, based on five-year data from a 10-year study conducted by Takeda. Results showed that while there was no overall association between use of Actos and risk of bladder cancer, and the FDA had not concluded that the drug necessarily increased the risk, there was an increased risk among those taking Actos for the longest period of time and in the highest cumulative dose.