❝ Almost a third of drugs cleared by the Food and Drug Administration pose safety risks that are identified only after their approval…
The researchers said the study, which appeared in JAMA, shows the need for ongoing monitoring of new treatments years after they hit the market.
❝ To win FDA approval, medications must be shown to be safe and effective. But many pivotal clinical trials used for approval involve fewer than 1,000 patients with follow-up of six months or less, according to the study. Safety problems often crop up years later after therapies have been used by much larger numbers of patients.
❝ The researchers reviewed 222 products approved between 2001 and 2010 and followed them through February of this year. With 32 percent of the medications, they found, the FDA took some kind of action to deal with safety issues that emerged after approval.
❝ Three of the drugs were withdrawn from the market. The FDA also required 61 new black-box warnings — the agency’s most serious safety alert, included in the drug’s packaging — and issued 59 safety communications to inform doctors and consumers about newly identified concerns. Some products had more than one boxed warning added or safety communication issued over the time of the study.
The median time for an FDA action was 4.2 years after approval…
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