When the Food and Drug Administration pulls drugs off the market because of possibly dangerous side effects, heart complications often are the concern.
A Bloomberg analysis has found that the risk of heart complications was a factor in 10 of the 21 drugs removed from the U.S. market since 1995 because of safety issues.
These include Roche’s blood-pressure drug Posicor, recalled in 1998, Johnson & Johnson’s antihistamine Hismanal, recalled in 1999, and Merck & Co.’s Vioxx, an arthritis drug. Vioxx was pulled in 2004 after a study suggested the drug doubled the risk of heart attacks after 18 months of treatment.
The withdrawn drugs were on the market from 11 months to 30 years before being pulled, Bloomberg reported.
The analysis follows last week’s near-withdrawal of GlaxoSmithKline’s diabetes drug Avandia, which has been found to increase the risk of heart attacks. U.S. regulators decided to sharply restrict use of the drug, while their European counterparts completely suspended sales.
Sen. Charles Grassley, R-Iowa, who has been highly critical of the FDA’s drug safety review process, told Bloomberg that the data supported his proposal for establishing an independent drug safety evaluation center within the agency.
Some doctors argue that heart risks can best be determined in large controlled studies but other experts say that requiring such reviews in all instances would inhibit the development of new drugs.
Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research, said the agency has begun requiring new safety tests to measure the heart risks of drugs used over long periods to treat chronic conditions.
Related posts:
FDA Slaps Tight Restrictions on Diabetes Drug Avandia
FDA Probes Glaxo’s Failure to Disclose Avandia Risks, Time Reports
Heart Studies Prompt FDA to Consider Pulling Diet Drug Meridia From the Market


