Drug Recalls

The pharmaceutical industry is both lucrative and cut-throat. Many companies face strong pressure to get their drugs on the market as soon as possible and to market them as broadly as they can. Pharmaceutical companies need to balance this pressure with the ethical obligation to exercise caution so that drugs are adequately tested before reaching the market. While some drug manufacturers scrupulously adhere to this ethical responsibility, others do not.

The Food and Drug Administration (FDA) is responsible for guaranteeing that drugs released on the market are safe for consumption. The process to receive FDA approval for a new drug is rigorous and can take a long time. In spite of this, it is still difficult to ascertain the long-term effects of a particular drug.

Furthermore, there are occasions when these tests are financed and carried out by the drug manufacturer's laboratories, which is clearly a conflict of interest.

When problems and harmful side effects develop in relation to an approved drug, the FDA can issue a recall. Recalls can be either voluntary or mandatory. If it is voluntary, the drug manufacturer decides to remove it from the market on its own. In mandatory recalls, the FDA orders a drug to be removed.

When a drug has the potential to cause serious or possibly fatal side effects, the FDA will issue a black box warning. It will appear either on the drug's label or in the literature accompanying the product. This is the most severe warning the FDA can issue for a drug.

Pharmaceutical drugs have contributed to more than 1,000 deaths since 1993. Some of the most serious drug recalls include:

* Fen-phen - More than six million Americans took this diet drug in the 1990's. Approximately 30% of women taking it developed heart valve abnormalities.
* Heparin - Heparin sodium is used as a blood thinner for patients who need heart surgery or kidney dialysis. Many patients who received large doses of the drug exhibited side effects including nausea, sweating, oral swelling, vomiting, and shortness of breath.
* Accutane - Accutane is an acne medication that was very successful in severe cases that did not respond well to other treatments. However, the drug can cause liver damage, birth defects, suicidal tendencies, and irritable bowel syndrome.