The GlaxoSmithKline diabetes drug Avandia topped list of drugs linked to fatal adverse events in 2009, according to an analysis of U.S. Food and Drug Administration records by Horsham, Pa.-based Institute for Safe Medication Practices.
Avandia topped the list with 1,354 deaths reported to the FDA in 2009. The drug, also known by its generic name rosiglitazone, has been the focus on scientific controversy over the possible health risks and Glaxo faces numerous lawsuits. Studies have shown Avandia increases risk of heart failure and other cardiovascular problems such as heart attacks and strokes. Glaxo has defended the way it handled the heart risk of Avandia.
Earlier this month, Glaxo confirmed that it had settled the first Avandia case scheduled for trial in the U.S. That case was set to be tried in state court in Philadelphia with the next case scheduled for trial in October. In May, Glaxo reportedly settled about 700 Avandia suits for about $60 million.
In the report ISMP said, “GlaxoSmithKline, told us earlier that it believed many of the adverse drug event reports for rosiglitazone were associated with possible lawsuits against the company.”
Another top drug on the list was Deferasirox, sold under the brand name Exjade. It is used by patients who have had a lot of blood transfusions to remove excess iron.
ISMP said that the FDA got 1,320 reports of deaths linked to Exjade in 2009.
Here is the list of the top 15 medications by number of deaths reported to the FDA in 2009:
Drug name Brandname(s) Deaths in 2009
ROSIGLITAZONE AVANDIA 1,354
DEFERASIROX EXJADE 1,320
IMATINIB GLEEVEC 261
SUNITINIB SUTENT 252
IBANDRONATE BONIVA 250
QUETIAPINE SEROQUEL 248
CAPECITABINE XELODA 218
SILDENAFIL VIAGRA, REVATIO 190
TACROLIMUS PROGRAF, PROTOPIC 180
Source: Institute for Safe Medication Practices
For the full ISMP report click here.
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