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Safety concerns often exist after drug approval

Harold Mandel's picture
drug approvals

Researchers say that new safety concerns have been identified for 33 percent of FDA approved drugs.


There have been growing concerns about the safety profile of many drugs. These concerns often persist even after drugs are cleared by the FDA.

The UN has blasted excessive medicalizing and torture by psychiatrists

Simply because drugs have been cleared for clinical use by the FDA that does not mean they are necessarily safe. The aggressive marketing and resultant prescribing of these drugs often leads to harm to patients. In Canada a post-market drug safety and effectiveness network has been developed to confront this problem. The problem of safety with psychiatric drugs is so serious the UN has blasted excessive medicalizing and torture by psychiatrists.

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There are safety concerns which have been identified for a third of FDA approved drugs reports Yale News. In the years after approval by the Food and Drug Administration (FDA) there is a new safety issue found in about 33 percent of drugs. This finding shows that there is a need for continued surveillance of new drugs during the
post-market period.

The FDA depends on premarket drug testing and clinical trials in order to assess the safety and effectiveness of new drugs. There are generally less than 1,000 patients studied over a period of six months or less for these trials. This makes it very hard to identify safety issues which might arise once more patients use the drug for a longer period of time.

32 percent of new drugs were identified as having a safety issue

The Yale research team analyzed data on new drugs which were approved between 2001 and 2010, with a follow up through 2017. The researchers discovered that 32 percent of new drugs were identified as having a safety issue after they were approved. Associate professor of medicine and public health Dr. Joseph Ross, who led the study, says this does not often lead to a drug withdrawal. However, black box warnings and new drug safety communication by the FDA to physicians and patients about new safety information is often seen.

The FDA appears to be under pressure to accelerate approvals of new drugs. Dr. Ross says when drug evaluation is persistently sped up there is the potential for compromising patient safety. It is hoped this study will help open up debate dealing with how premarket drug evaluation is done.

This study has been published by JAMA. Postmarket safety events are often seen with novel pharmaceuticals and biologics after initial regulatory approval of these therapeutics. There have been statistically significantly higher rates of these safety events seen with biologics and psychiatric therapeutics. There is clearly a need to continue to monitor the safety of novel therapeutics even after FDA approval.