TOP FIVE BIGGEST DRUG RECALLS
In 1961, the drug Thalidomide prompted Congress to create the Kefauver-Harris Drug Amendments after 10,000 to 20,000 were affected by birth defects caused by the drug. Congress gave authority to the FDA to oversee the pharmaceutical industry and required companies to prove their products were safe for use.
Each of the following five drug recalls created a huge outcry after these drugs injured thousands of people:
- Fen-phen: This popular weight-loss drug was recalled in 1997 after more than 50,000 consumers began experiencing heart problems. Today, combined legal expenses and awards have cost manufacturer Wyeth more than $21 billion dollars.
- Diethylstilbestrol (DES): DES was prescribed to women to prevent miscarriages during pregnancy, and it was more than 30 years before doctors connected the drug to a rare tumor that presented in the daughters of patients who took the drug. The drug was never patented, so each individual manufacturer paid legal damages according to market share.
- Cerivastatin (Baycol): This cholesterol drug was made by Bayer and cost $6 billion in damages from 100,000 deaths from a severe muscle disorder that clogs the kidneys with muscle tissue.
- Rofecoxib (Vioxx): Vioxx was an arthritis pain reliever that caused the biggest drug recall in history after accusations that both Merck and FDA both ignored evidence of danger from the drug. The more than 140,000 cases of coronary disease caused by the drug were settled for $4.8 billion after five years on the market.
- Valdecoxib (Bextra): Another NSAID put on the market for arthritis sufferers, Bextra was pulled by Pfizer after just one year and cost them more than $2 billion in legal awards and fees after the drug increased risk of heart attack and stroke and caused a fatal condition. In the end, the Pfizer subsidiary Pharmacia & UpJohn Company was fined nearly $2 billion after admitting to “intend to defraud or mislead” in promoting the drug.