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News > Science and Tech

Nearly 1 in 3 Drugs Have Safety Issues Even After FDA Approval

  • The report says the FDA failed to secure drugs approved, as criticism sparks over slow processes

    The report says the FDA failed to secure drugs approved, as criticism sparks over slow processes | Photo: Reuters

Published 14 May 2017

New research shows that nearly one in three drugs approved by the U.S. Food and Drug Administration, or FDA, have health and safety issues, raising concerns about carelessness within the organization.

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According to the report, commissioned by Yale University, prescription drugs used to treat mental health issues such as depression were more likely to have these issues.

"The fact that so many new safety risks are being identified after FDA approval indicates that the FDA is taking its responsibility of ensuring the safety of new drugs throughout their lifetime seriously," said one of the researchers, Nicholas Downing from Brigham and Women's Hospital.

Researches studied the effects of 222 drugs between 2001 and 2010 and found that 32 percent of them had safety issues. Only three drugs were pulled from the market during the study period.

It took years after the drugs had been approved for safety concerns to arise, meaning citizens would have taken most of the drugs without knowing the health risks.

"However, these safety risks emerge, on average, four years after approval. This means that many patients are exposed to these medications before the risks become clear," Downing said.

Antidepressants, autoimmune, migraine, and erectile dysfunction medication had more safety warnings, according to the investigations.

"It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up," said lead researcher Joseph Ross from Yale University. 

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Previous research shows that the FDA approves drugs faster than other organizations in Europe and most clinical trials involved less than a thousand patients. Most of the trials lasted six months or less, making it difficult to identify long-term issues.

The investigation comes as the government has called the FDA to speed up the drug approval process.

The FDA said they're reviewing the study and hope it will be used to draft a drug approval policy in the future.

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