THURSDAY, Nov. 4 (HealthDay News) -- Ofirmev has been approved
by the U.S. Food and Drug Administration to treat fever and
mild-to-moderate pain, maker Cadence Pharmaceuticals said in a news
release.
It's the first FDA-approved injected version of acetaminophen,
the San Diego company said. Acetaminophen is the active ingredient
in Tylenol.
Approval followed clinical studies involving 1,020 adults and
355 pediatric patients aged 2 and older. The drug's effectiveness
to treat pain and fever hasn't been studied in children younger
than 2, Cadence said.
The most common side effects of Ofirmev included nausea,
vomiting, headache, insomnia, constipation and agitation. The drug
shouldn't be used by people with active liver disease, alcoholism
or a known sensitivity to acetaminophen, the company said.
More information
To learn more about acetaminophen, visit the
FDA.