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One-Third of Approved Drugs Have Safety Issues

Blue PillsOne-third of all drugs approved by the U.S. Food and Drug Administration (FDA) are later discovered to have safety problems, according to a new study. The results are very concerning given that the Trump Administration is exploring ways to speed up the drug approval process.

Researchers examined 222 prescription drugs approved by the FDA from 2001 through 2010. In total, 71 drugs were withdrawn, required a "black box" warning regarding newly discovered side effects, or necessitated an FDA safety communication regarding new risks.

In several cases, the safety issues linked to the drugs included deaths or life-threatening conditions. The three drugs that were removed from the market were Bextra, an anti-inflammatory drug; Zelnorm, which was used to treat irritable bowel syndrome; and Raptiva, a medication used for psoriasis. Bextra and Zelnorm were withdrawn due to cardiovascular risks, while Raptiva was discovered to increase the risk of a rare and potentially-deadly nervous system infection that causes brain damage.

The study, which was published in the Journal of the American Medical Association, revealed that safety issues were most common for psychiatric drugs and biologic drugs (drugs manufactured using living cells rather than chemicals). Drugs subject to the FDA’s "accelerated" approval process and those approaching the regulatory deadline for approval were also more likely to have problems down the road.

“The large percentage of problems was a surprise,” and they included side effects not seen during the review process, said Dr. Joseph Ross, the study’s lead author and an associate professor of medicine and public health at Yale University.

According to the researchers, their findings highlight the need for continuous monitoring of the safety of new drugs throughout their life cycle. “While the administration pushes for less regulation and faster approvals, those decisions have consequences,” Ross noted.

We agree that while it is important to get new drugs to patients who need them, new treatments still need to undergo sufficient efficacy and safety testing. If not, the medications may ultimately do patients more harm than good.

If you or someone you love has suffered serious harm due to a dangerous or defective drug, don’t hesitate to contact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.