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A rare side effect, aseptic meningitis, has developed in people taking
the painkiller Vioxx, the US Food and Drug Administration (FDA)
reported March 25.
Meningitis is an inflammation of the membranes covering the brain
and spinal cord. Aseptic meningitis is not considered as severe
as meningitis caused by a bacterial infection, but it is serious
and required hospitalization in all five of the Vioxx-associated
cases.
Vioxx is prescribed for osteoarthritis pain, acute pain and menstrual
pain. It was approved by the FDA in May 1999. Between then and February
2001, the FDA received seven reports of
aseptic meningitis in patients taking Vioxx. In two cases
not enough information was included for FDA investigators to assess
whether the meningitis was related to use of the drug.
The other cases are believed to be associated with Vioxx because
the patients developed two or more symptoms of aseptic meningitis
1 to 12 days after they began using the drug. These included headache,
fever, sensitivity to light, neck stiffness and confusion.
Another fact that suggests a link to Vioxx use was that the patients
recovered completely once they stopped taking the drug. One patient
was restarted on Vioxx twice, and both
times the symptoms of meningitis reappeared.
The five patients, ages 16 to 67, were on dosages ranging from
12.5 to 50 milligrams per day. The FDA's report does not go so far
as to state that Vioxx caused aseptic meningitis in these patients.
Archives of Internal Medicine
March 25, 2002;162:713-715
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