One-third of all drugs approved by the U.S. Food and Drug Administration
(FDA) are later discovered to have safety problems, according to a new
study. The results are very concerning given that the Trump Administration
is exploring ways to speed up the drug approval process.
Researchers examined 222 prescription drugs approved by the FDA from 2001
through 2010. In total, 71 drugs were withdrawn, required a "black
box" warning regarding newly discovered side effects, or necessitated
an FDA safety communication regarding new risks.
In several cases, the
safety issues linked to the drugs included deaths or life-threatening conditions. The three drugs that were
removed from the market were Bextra, an anti-inflammatory drug; Zelnorm,
which was used to treat irritable bowel syndrome; and Raptiva, a medication
used for psoriasis. Bextra and Zelnorm were withdrawn due to cardiovascular
risks, while Raptiva was discovered to increase the risk of a rare and
potentially-deadly nervous system infection that causes brain damage.
which was published in the
Journal of the American Medical Association, revealed that safety issues were most common for psychiatric drugs and
biologic drugs (drugs manufactured using living cells rather than chemicals).
Drugs subject to the FDA’s "accelerated" approval process
and those approaching the regulatory deadline for approval were also more
likely to have problems down the road.
“The large percentage of problems was a surprise,” and they
included side effects not seen during the review process, said Dr. Joseph
Ross, the study’s lead author and an associate professor of medicine
and public health at Yale University.
According to the researchers, their findings highlight the need for continuous
monitoring of the safety of new drugs throughout their life cycle. “While
the administration pushes for less regulation and faster approvals, those
decisions have consequences,” Ross noted.
We agree that while it is important to get new drugs to patients who need
them, new treatments still need to undergo sufficient efficacy and safety
testing. If not, the medications may ultimately do patients more harm
If you or someone you love has suffered serious harm due to a dangerous
or defective drug, don’t hesitate to
a San Diego product liability attorney at the Law Offices of Robert Vaage
for a free consultation.