A new study has found that 1 in 3 therapeutic products greenlit by the FDA are linked to new safety risks after approval.

Pills in man's hand

Pre-approval clinical trials aren't enough to catch the side effects of many drugs. That's the conclusion of a new study, published by the Journal of the American Medical Association, on the amount of "safety events" flagged after a drug is released to the market.

Third Of Drugs Have Unknown Risks Upon Approval

Reviewing 222 drugs approved between January 1, 2001 and December 31, 2010, an international team of researchers found that nearly 1 in 3 products had been linked to a safety event that was only noticed after approval by February 28, 2017. In total, 123 new safety events were identified in that time period, leading to 3 product withdrawals and 61 "black box" warnings.

The group hailed from Yale, Harvard, the State University of New York and several French hospitals.

Dangers May Slip Through Gaps In Hasty Pathways

Just over 200 therapeutic products may not sound like a lot, but that's the total number of FDA-regulated medicines approved between 2001 and 2010. Approvals skewed heavily toward pharmaceuticals; only 39 of the products were classified as "biologics," a category that would include some vaccines, which are based in small samples of a virus.

Most of the safety events identified weren't observed for years. The median gap between approval and risk establishment sat around 4.2 years. The vast majority of risks had been caught by 10 years. Those drugs funneled through accelerated approval pathways were significantly more likely to be associated with a postmarket safety event.

Joseph Ross, the study's lead author and an associate professor of medicine at Yale, said, "we seem to have decided as a society that we want drugs reviewed faster." The Trump administration has signaled its hope of speeding up approval even more, but, as Ross told the Washington Post, that makes "a strong system [...] to continually evaluate drugs" more important than ever.

Biologics Linked To Higher Rate Of Safety Events

Despite the discrepancy in numbers, biologic products were far more likely to become associated with major safety risks than pharmaceuticals.

Technically, biologics are manufactured, not through chemical synthesis, but in biological systems. Scientists use plant and animal cells, often genetically-engineered, to create living factories that produce complex molecules with therapeutic applications. Biologics are usually more complicated than pharmaceutical drugs. In fact, these substances are often so intricate that their properties cannot be fully characterized in the lab.

Psychiatric treatments were another point of emphasis, nearly four times as likely to be linked to new safety risks than products designed for other conditions.

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About Laurence Banville

Attorney Contributor:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including negligent security cases, child sexual abuse and Dram Shop and liquor liability cases.

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