How Safe Are America's Medicines?
No. 1 of WebMD's Top 10 Stories of 2004: A series of drug removals and warnings opened up a floodgate of questions over the safety of drugs. What have we learned, and what can we expect in the future?
By Daniel DeNoon
Reviewed By Michael Smith
Are medicines safe for us and for our children? Americans once thought so. Now we aren't so sure.
It's been a shaky year for our faith in U.S. drug safety:
- Heart safety questions led to the withdrawal of the arthritis drug Vioxx.
- Vioxx's sister drugs Celebrex and Bextra are reported to have heart safety concerns. (In April 2005 the FDA asked that Bextra be pulled from the market because of heart, stomach and skin risks).
- The FDA releases heart warnings about the over-the-counter pain reliever Aleve. (In April 2005 the FDA asked makers of over-the-counter anti-inflammatory drugs to revise their labels to include more specific information about the potential of ulcer, heart, and stroke risks.
- Antidepressant drugs now carry a new "black-box" warning about suicide risk.
- The ADHD drug Strattera is associated with -- in a very small number of patients -- serious liver damage.
- A maverick FDA drug reviewer told Congress that several drugs now on the market may not be safe. He acknowledged he did not speak for the FDA, which finds the drugs safe when used properly. The drugs (Crestor, Bextra, Meridia, Accutane, and Serevent) remain on the market.
- A three-year-old study of the FDA's drug review process surfaced late this year. It shows that nearly one in five FDA reviewers felt pressured to approve a drug, and that two out of three FDA reviewers lack confidence in how the FDA monitors the safety of a drug once it is approved. The report, from the Health and Human Service's inspector general's office, concludes that "these findings present a significant warning signal."