In One-Third of Drugs, Safety Issues Identified after Approval
A new study published in the Journal of the American Medical Association (JAMA) highlights the need for ongoing safety monitoring after drugs are approved and sold. Researchers found that, in about one-third of drugs approved by the U.S. Food and Drug Administration (FDA), safety problems are identified after approval. To gain clearance for a new drug, manufacturers must submit data showing that the medication is safe and effective. According to study authors, however, oftentimes these trials involve less than 1,000 patients and conduct follow-up for six months or less. Drug safety issues often take years to appear.
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The study was published on May 9, 2017. Investigators looked at 222 new drugs approved by the FDA from 2001 through 2010. Among these, safety issues were identified in 71 drugs (32 percent); this means regulators took some type of action to address a safety concern.
At a median follow-up of 11.7 years, three medications were removed from the market altogether. A total of 61 new black-box warnings were added; this is the most serious type of safety alert included on a drug’s packaging. Researchers also found that the agency issued 59 safety communications, in which regulators notified consumers and the medical community about potential safety risks.
The study found that the median for regulatory action was 4.2 years after approval.
At 10 years, the proportion of drugs affected by a postmarket safety action was 30.8 percent.
Researchers noted that postmarket safety issues were commonly identified with psychiatric drugs, drugs approved through the accelerated problem, and drug approved close to the deadline. The authors stated, “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.”
“Postmarket safety events are common after FDA approval, highlighting the importance of continuous monitoring of the safety of novel therapeutics throughout their life cycle,” authors concluded.
The FDA has four separate routes for expediting drug approval: priority review, breakthrough therapy, accelerated approval and fast track. Fast track promotes the development and review of drugs needed for serious conditions that fulfill an unmet medical need. Breakthrough therapy focuses on a new treatment that may be superior to an existing treatment.
Accelerated approval involves drugs for serious conditions with an unmet need. This type of approval is based on surrogate endpoints, which suggest a clinical benefit but are not direct measures of clinical benefit itself. A priority review means that the FDA seeks to act on an application within 6 months.
Study Highlights Need for Ongoing Drug Safety Monitoring
The lead author is Joseph Ross, an associate professor of medicine and public health at Yale University. “We seem to have decided as a society that we want drugs reviewed faster,” he said, according to The Washington Post. As such, it especially crucial “that we have a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively,”
“No drug is completely safe, and during premarket evaluation, we are not going to pick up all the safety signals,”
A spokeswoman at the FDA said, according to The Washington Post “FDA performs post-market monitoring to identify new safety information that may impact product labeling. In general, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”
The Washington Post also interviewed Eric Topol, founder and director of Scripps Translational Science Institute. Topol, who was not involved in the study, commented, “the fact that it is one out of three of FDA-approved drugs is troubling.”
He said that clinical trials often do not reflect real-world results, because participants are frequently cherry-picked to produce the best results. Topol proposed that regulators conditionally approve drugs and gather safety data from every patient early on. “Why not have a standard where we put every new drug under watch, and see if we could catch a problem before the drug is widely advertised?” he suggested.
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