Fw: FDA issues Vioxx warning - March 25, 2002

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Sent: Monday, March 25, 2002 4:42 PM

Subject: FDA issues Vioxx warning - March 25, 2002

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http://www.cnn.com/2002/HEALTH/conditions/03/25/vioxx.meningitis.ap/index.ht

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> FDA issues Vioxx warning

>

> CHICAGO, Illinois (AP) --The popular painkiller Vioxx has been linked to

> five cases of a nonbacterial type of meningitis, a possible side effect

> that, although rare, is serious, the U.S. Food and Drug Administration

> reports.

>

> The cases are among seven reported to the FDA from May 1999 -- when it

> approved Vioxx for arthritis and other acute pain -- through February

2001,

> according to the report in Monday's Archives of Internal Medicine.

>

> Some 52 million Vioxx prescriptions have been written in the United States

> since June 1999, a spokeswoman for Merck & Co. said.

>

> All seven patients were taking Vioxx when they developed meningitis, but

> two cases lacked enough information to determine possible causes, the

> report said.

>

> Since February 2001, meningitis also has been reported in five other Vioxx

> patients, but those cases have not been evaluated in detail, said Renan

> Bonnel of the FDA's Center for Drug Evaluation and Research, an author of

> the report.

>

> No one has died in any of the cases, Bonnel said.

>

> The report notes that other nonsteroidal anti-inflammatory drugs,

including

> ibuprofen and naproxen, also have been linked in rare cases to meningitis.

> Celebrex, a drug similar to Vioxx, has been linked to six cases of

> meningitis but the reports " contain very little or no information to

assess

> causality, " Bonnel said.

>

> The Vioxx patients described in Archives were ages 16 to 67 and developed

> symptoms up to 12 days after starting the drug. Symptoms included

headache,

> stiff neck, eye pain, fever and chills.

>

> " All cases were serious, requiring hospitalization, " the report said.

>

> The diagnosis was aseptic meningitis, inflammation of the brain and spinal

> cord that is not caused by bacteria and is generally less severe than

> bacterial meningitis. It is sometimes caused by a virus or a medication

and

> the FDA report doesn't say it was definitely caused by Vioxx.

>

> However, the FDA has required Merck to add meningitis to the list of

> potential side effects included on the Vioxx product label and package

> insert. Merck spokeswoman Fanelle said the company added the

> information in 2000.

>

> Fanelle said that just because an adverse event occurs in patients " does

> not prove that the drug causes it, " and the reported cases represent a

tiny

> fraction of the 52 million Vioxx prescriptions.

>

> " This is a rare event and we don't think this is cause for worry, " Fanelle

> said.

>

> Vioxx also has been scrutinized for data that some say suggests a possible

> link to heart attacks, though Merck disputes that conclusion.

>

>

>

>

> Find this article at:

>

http://www.cnn.com/2002/HEALTH/conditions/03/25/vioxx.meningitis.ap/index.ht

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