Drug Side Effects Commonly Found Years After FDA Approval: Study

New drugs approved by federal regulators are commonly linked to serious side effects, which were missed or overlooked when the manufacturer originally researched and introduced the medication, according to the findings of a new study. 

Researchers from Yale, the Mayo Clinic and Brigham and Women’s Hospital published a study on May 9 in Journal of the American Medical Association (JAMA), which indicates that a third of all FDA-approved drugs later need to have updated label warnings or are recalled from the market due to adverse health effects.

The study looked at 222 new drugs and biologics approved from 2001 and 2010, and followed up on those medications up to February 29, 2017. They looked for drugs that received updated postmarketing information, such as boxed warnings, safety communications or recalls due to safety issues.

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According to the findings, about 32% of the drugs were later linked to problems not seen in the initial studies. These included three drugs that were completely removed from the market, 61 boxed warnings, and 59 safety communications. The findings indicate that the median time between a drug being approved and receiving a postmarket safety event was 4.2 years.

Researchers indicate that biologics, which are genetically engineered proteins, like insulin and human growth hormones, and drugs used to treat pyschiatric problems were more frequently linked to postmarket health problems than other pharmaceuticals.

The study also found that drugs that underwent an accelerated approval process were more than twice as likely as other drugs to be later associated with new adverse health side effects.

“Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event,” the researchers determined. “Biologics, psychiatric therapeutics, and accelerated and near-regulatory deadline approval were statistically significantly associated with higher rates of events, highlighting the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.”

The findings raise serious concerns, as the FDA has been criticized for its failure to follow up on such postmarket surveillance, allowing approved medications to stay on the market even when manufacturers fail to follow through with required studies designed to ensure they are safe and effective.

In January 2016, a report by the Government Accountability Office (GAO) warned that the FDA was approving too many drugs through fact-track approval processes, and then failing to adequately monitor those drugs once they hit the market.

The GAO’s findings were similar to warnings issued in a report released by the Institute of Medicine of the National Academies in 2012, which found that the agency’s current approach to drug oversight after medications are approved is not sufficient and does not ensure that the benefits and risks of drugs are consistently monitored over the life cycle of the product.

While the FDA has said it is working on fixing the problem and that its postmarketing surveillance of drugs is improving, the GAO report pointed out that most of the possible drug safety issues the FDA already identified as potential problems were not being tracked through the FDA database. This could be because of the nature of the software the agency uses to update that data, which the review found to be problematic and likely made it harder for staffers to enter data.

The report comes at a time when the agency and pharmaceutical companies have called for ways to make it easier and cheaper to get new drugs on the market.


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