Almost one-third of new drugs approved by U.S. regulators over a decade ended up years later with warnings about unexpected, sometimes life-threatening side effects or complications, a new Associated Press analysis found.
The results covered all 222 prescription drugs approved by the U.S. Food and Drug Administration from 2001 through 2010. The researchers looked at potential problems that cropped up during routine monitoring that’s done once a medicine is on the market.
The 71 flagged drugs included top-sellers for treating depression, arthritis, infections and blood clots. Safety issues included risks for serious skin reactions, liver damage, cancer and even death.
New drugs are generally tested first in hundreds or even thousands of people for safety and effectiveness.
The researchers analyzed online FDA data on new drugs and the agency’s later safety announcements. Problems surfaced on average about four years after approval. Results were published in early May in the Journal of the American Medical Association.
The study counted black-box warnings for dozens of drugs; these involved serious problems including deaths or life-threatening conditions linked with the drugs. There were also dozens of alerts for less serious potential harms and three drug withdrawals because of the potential for death or other serious harm.
Safety issues were most common for psychiatric drugs and biologic drugs – made from living cells rather than chemicals – than for older drug types. Drugs brought to market through “accelerated” approval were slightly more likely to have later safety issues than those approved through conventional channels, a link seen in some previous research.
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