FDA News and Discussions

The FDA has recently completed a comprehensive review of the safety data for both Prilosec and Nexium. Recently, there have been concerns voiced in the media about the safety of these drugs. Often times, the media is quick to jump on a report that may suggest an issue with a pharmaceutical product, the reality of the situation is often much more complex and needs to be thoroughly reviewed before any assumptions are made or published.

FDA advisers recently suggested that the world's most widely used flu drug should carry stronger warnings. The current warning label references the fact that there have been reported cases of delirium and self-injury. The panel of advisers suggested that the FDA require the manufacturer, Roche, to include language about recent deaths in Japan based on abnormal behaviors. Five deaths have been reported in Japan after children had been prescribed Tamiflu, the children falling out of windows or running into traffic caused the deaths.

The FDA recently released a statement that Crestor, a cholesterol-lowering statin manufactured by AstraZeneca could in rare cases increase the risk of a life threatening muscle disease known as rhabdomyolysis. New warnings and instructions were proposed by the company and approved by the FDA, and were sent out to doctors as part of the industry’s new approach to ensuring patients and doctors are well informed of any risks associated with their medications.

While the risk of rhabdomyolysis has been well known about with statins for some time, it appears the risk is somewhat greater in Crestor, than with some of the others in the same class such as Pfizer’s Lipitor. The new warnings signal a change in the industry, with all the recent lawsuits filed over COX-2 painkiller Vioxx’s side effects the pharmaceutical industry is taking every step possible to ensure the public is well aware of every possible side effect.

An FDA advisory panel recently voted 31-1 to allow COX-2 Inhibitor painkillers to remain on the market. COX-2 Inhibitors are manufactured by a number of companies, such as Pfizer’s Celebrex and Bextra or the recently pulled Merck Vioxx. The panel felt that the benefits of the drugs far outweighed the potential risks. They feel the risk versus benefit decision is best left up to the doctor and patient. Once the FDA formally rules on the issue, Merck has said that re-introducing Vioxx to the market is not out of the question.

Recently an FDA advisory panel voted 20 to 3 to not allow Merck to sell it’s cholesterol-lowering statin, named Mevacor, as an over-the counter medication. Although most doctors agree that millions of Americans could benefit from taking statins to help control their cholesterol, the panel found that was just not enough data to prove to them that the drug would be safe to start taking with first consulting a doctor. This leaves open the possibility of Merck conducting more clinical trials and providing the panel with more safety data.