Dangerous drugs and devices for women removed from market

Women have historically played an important role in supporting safe food and effective medicines¹, with the support of women's groups helping to usher in the modern FDA.² Today, FDA is responsible for approving medications based on data from clinical trials. But the FDA's supervision of drugs doesn't end with approval. The agency continues to collect information about complications from drugs and medical devices after they are on the market.³ Sometimes, for example, a drug or device may have side effects not shown in clinical trials. When this happens, the FDA reviews the facts and may request withdrawal of the drug or device from the market.

Instances when the FDA removed drugs or devices from the market, or limited their use, due to safety concerns include the following:

• In 1992, the FDA restricted silicone gel-filled breast implants to women who needed reconstruction surgery or their existing silicone gel-filled implants replaced. The FDA has since continued to work with manufacturers on improving the safety of these implants.⁴
• In 1997, the FDA removed the appetite suppressants fenfluramin and dexfenfluramine because of increased risk for heart valve disease.⁵
• In 1988, the FDA removed birth control pills containing more than 50 micrograms of estrogen from the market because of a higher risk for rare but fatal thromboembolisms.⁶
• In 2011, the FDA cautioned women about the complications that can occur when surgical mesh is used to treat pelvic organ prolapse and stress urinary incontinence.⁷

Learn more about the stages of drug development and review by the FDA.

Sources

1. FDA, 100 Years of Protecting and Promoting Women's Health
2. FDA, The Story of the Laws Behind the Labels
3. FDA, The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective
4. FDA, Regulatory History of Breast Implants in the U.S.
5. FDA, Fen-Phen Safety Update Information
6. FDA, 100 Years of Protecting and Promoting Women's Health
7. FDA, Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse