Posted by Article on 4/2/2002, 10:53 am

Non-Bacterial Meningitis Linked to Vioxx Use Mon Mar 25, 1:57 PM ET By Faith Reidenbach NEW YORK (Reuters Health) - In a small number of cases, a rare side effect, aseptic meningitis, has developed in people taking the painkiller Vioxx, the US Food and Drug Administration (news - web sites) (FDA) reported Monday. 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 (rofecoxib) 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 development of aseptic meningitis was an "idiosyncratic" reaction, the FDA says, meaning that these patients probably had an abnormal susceptibility to the drug that was peculiar to those individuals. The FDA's report, published in the March 25th issue of Archives of Internal Medicine (news - web sites), does not go so far as to state that Vioxx caused aseptic meningitis in these patients. As Christine Fanelle, a spokeswoman for Merck, the drug's maker, told Reuters Health, "The fact that an adverse event occurs while a patient is taking a medication does not necessarily prove that the drug has caused the event. "This rare adverse experience has been in our prescribing information for the past 2 years," Fanelle added. "Patient safety is of great importance to Merck, and we believe that the information is clearly given to physicians and to patients. It's also in the patient packaging insert." Vioxx belongs to a relatively new class of anti-inflammatory drugs called COX-2 inhibitors. Some older anti-inflammatory drugs, including ibuprofen and naproxen, have been linked to aseptic meningitis in rare cases. The five cases reported Monday are the first to be associated with a COX-2 inhibitor. SOURCE: Archives of Internal Medicine 2002;162:713-715.

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