Report Links Vioxx to Meningitis

[Guest guest]

Wouldn't have expected that, a. Thanks for the warning.

[ ] Report Links Vioxx to Meningitis

>

> Report Links Vioxx to Meningitis

>

>

> Sunday, March 24, 2002 4:28 p.m. EST

>

>

>

>

> By LINDSEY TANNER AP Medical

> Writer

>

> CHICAGO (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 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.

>

>

>

http://news.lycos.com/news/story.asp?n_2=1 & section=MyLycos & pitem=AP%2DVi

oxx%2DMeningitis & rev=20020324 & pub_tag=APONLINE

[Guest guest]

Report Links Vioxx to Meningitis

Sunday, March 24, 2002 4:28 p.m. EST

By LINDSEY TANNER AP Medical

Writer

CHICAGO (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 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.

http://news.lycos.com/news/story.asp?n_2=1 & section=MyLycos & pitem=AP%2DVioxx%2DMe\

ningitis & rev=20020324 & pub_tag=APONLINE