Nearly one in three drugs
found to have safety concerns after FDA approval
Brigham and Women's Hospital
How often are safety concerns raised about a drug after it's
been approved by the FDA?
Nicholas Downing, MD, of the Department of Medicine at Brigham
and Women's Hospital, and colleagues have found that for drugs approved between
2001 and 2010, nearly 1 in 3 had a postmarket safety event.
The team defines post-market safety events as those that lead to
either withdrawal from the market due to safety concerns, a boxed warning or
FDA issuance of a safety communication.
They found that of 222 novel therapeutics the FDA approved
during this time period, three were withdrawn, 61 received boxed warnings and
59 elicited safety communications. The team's findings are published in JAMA.
"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 Downing, lead author of the study.
"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."
The team found that three drugs had been withdrawn from the
market over an average follow-up period of 11.7 years.
Boxed warnings, which are issued when new, life-threatening risks
are identified, were issued for 61 drugs, including antipsychotics, SSRIs
(selective serotonin reuptake inhibitors) and a class of drugs for the
treatment of autoimmune disease.
Safety communications, which are issued when new, serious risks
are identified, were issued for 59 drugs, including drugs for migraine,
erectile dysfunction and diabetes.
Post-market safety events were significantly more frequent among
biologics, therapeutics indicated for the treatment of psychiatric disease,
those receiving accelerated approval and those with near-regulatory deadline
approval. Events were significantly less frequent among drugs with regulatory
review times less than 200 days.
"This analysis highlights that there is residual
uncertainty about the risks and benefits of new drugs at the time of approval,
thereby demonstrating the need for all stakeholders engaged in the drug
development process to commit to the generation of clinically useful
information both before and after regulatory approval," said Downing.