The US FDA has put a class of
antiemetic drugs, including ondansetron on its latest quarterly list of
products to monitor because of potential signals of an increased risk for
serotonin syndrome.
The beta blocker
metoprolol succinate also landed on the list because of reports that suggested
therapeutic ineffectiveness.
Appearance on the
watch list does not mean that the agency has concluded that the drug poses the
health risk reported through FAERS. What it does mean is that the FDA will
investigate whether there is a causal connection.
The antiemetics on the
watch list belong to a subtype of serotonin blockers that bind to the 5-HT3
receptor. Serotonin syndrome is caused by excessive levels of the
neurotransmitter. It can be fatal. Symptoms include confusion, agitation,
dilated pupils, headache, rapid heart rate, and changes in blood pressure and
temperature.
Product name: active ingredient (trade) or product
class
|
Potential signal of a serious risk/new safety
information
|
Additional information (as of May 1, 2013)
|
Metoprolol succinate extended-release
products
|
Lack of therapeutic effect, possibly related to
product quality issues
|
FDA is continuing to evaluate this issue to
determine the need for any regulatory action.
|
Serotonin-3 (5-HT3) receptor antagonist products:
ondansetron, palonosetron
|
Serotonin syndrome
|
FDA is continuing to evaluate this issue to
determine the need for any regulatory action.
|
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