Journal notes heart-related risks posed by Avandia
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.
Report: Menthol-flavored cigarettes could be latest banned tobacco product
WASHINGTON — Menthol-flavored cigarettes are the latest target for tobacco opponents, according to published reports.
Reuters reported Friday that a committee of advisers to the Food and Drug Administration said in a report that banning mentholated cigarettes would benefit public health. Under legislation adopted in 2009, most flavored cigarettes already are banned.
The Food and Drug Administration will consider banning or limiting menthol when it receives the report Wednesday, though analysts have said a ban on menthol cigarettes is unlikely, Reuters reported.
Lilly issues warning over alcohol prep pads associated with Forteo
INDIANAPOLIS — Drug maker Eli Lilly is warning patients to avoid using alcohol prep pads that come with one of its osteoporosis drugs due to the risk of bacterial infections.
Lilly said Thursday that patients should not use pads made by the Triad Group contained in the black starter kits for Forteo (teriparatide [rDNA origin]). Triad is recalling prep pads due to potential contamination with Bacillus cereus, which can cause life-threatening infections in some patients. The recall does not affect the delivery device of Forteo, which is used for preventing bone fractures in men and postmenopausal women with osteoporosis.
Several companies, including Genentech and Bayer, have warned patients not to use Triad Group prep pads included with their drugs since Triad began the recall in January.