Product News and Recalls

FDA reviewer recommends against Pfizer drug

A U.S. Food and Drug Administration medical reviewer recommended the agency not approve tafamidis, a drug developed by a Pfizer Inc. subsidiary to treat a rare genetic disorder that affects the nervous system. The reviewer said there was “inadequate” evidence the drug works, according to the Wall Street Journal.

This is the second recent setback for Pfizer. Last week, the New England Journal of Medicine published a study that found the pharmaceutical giant’s popular antibiotic azithromycin, sold under the brand name Zithromax, caries a small but significant risk of sudden death from heart problems.

Pfizer subsidiary FoldRx is seeking FDA approval of tafamidis to treat an inherited condition called transthyretin familial amyloid polyneuropathy, believed to affect 8,000 people world-wide.

A panel of non-FDA experts will review tafamidis this week, and the FDA released a review in preparation for the meeting. The drug has a proposed brand name of Vyndaqel and was approved in Europe last year. An agency division head said in a memo that the FDA hasn’t made a final decision on tafamidis.

The study on Zithromax was big news because the antibiotic is widely used to treat common infections such as bronchitis and pneumonia. Researchers looked at more than 500,000 Medicaid recipients from Tennessee over a span of 14 years and found that patients who took a five-day course of Zithromax were more than twice as likely to die than people taking different antibiotics. This risk was even higher for people who already had cardiovascular disease.

The FDA, in announcing the study results, cautioned that patients should not stop taking the medication without first checking with their doctors.

If you or a loved one suffered a heart injury while on Zithromax, then you should consider consulting with an attorney who handles pharmaceutical cases.

See the Wall Street Journal report here: http://online.wsj.com/article/BT-CO-20120522-709918.html