Medwatch Update

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Hi All,

Here is some new Medwatch updates.

You can get these updates sent to your email from

www.fda.gov/medwatch

Fred

12/22/2004

Liver Toxicity Warning Added to Infliximab (Remicade) Prescribing Information

A new warning describing rare reports of liver toxicity associated with

infliximab (Remicade, by Centocor). The liver toxicity may include acute liver

failure, jaundice (yellowing of the skin and whites of eyes), hepatitis, and

cholestasis. Some of these cases have caused death or required liver

transplantation. Additionally, autoimmune hepatitis has been diagnosed in some

of these cases. The onset of the liver toxicity typically occurred between two

weeks to more than a year after infliximab initiation. Liver toxicity has been

reported in approximately 3 patients in controlled clinical trials and 35

patients in voluntary postmarketing reported events. Approximately 576,000

patients have been treated with infliximab worldwide.

Patients should contact their physician immediately if signs or symptoms of

liver toxicity appear. Signs and symptoms of liver toxicity may include the

following:

Jaundice (yellowing of the skin or whites of the eyes)

Nausea

Vomiting

Abdominal pain

Elevated liver enzymes

Find more information at FDA MedWatch.

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12/20/2004

Study Halted Following Evidence of Increased Heart Risks with Naproxen (Aleve)

The National Institutes of Health (NIH) halted a clinical trial involving the

nonsteroidal anti-inflammatory drug (NSAID) naproxen (Aleve, Naprosyn) due to

preliminary information showing evidence of increased risk of cardiovascular

events, such as heart attack or stroke.

The trial is known as the Alzheimer Disease Anti-Inflammatory Prevention Trial

(ADAPT). The NIH has been studying the effects of naproxen (220 mg twice daily),

celecoxib (Celebrex, 200 mg twice daily) and placebo (sugar pills) to assess the

potential benefits to decrease the risk of developing Alzheimer Disease. The

study specifically included people 70 years or older who were considered to be

at increased risk because of family history, but did not have symptoms of the

disease.

Although no significant increase in risk for celecoxib was found in this trial,

the use of these drugs in the study was suspended in part because of findings

reported last week from a National Cancer Institute (NCI) trial to test the

effectiveness of celecoxib in preventing colon cancer (see eMedicine Alert

12/17/04). In addition, however, data from the ADAPT trial indicated an apparent

increase in cardiovascular and cerebrovascular events among the participants

taking naproxen when compared with those on placebo.

The NIH and FDA will further review of the scientific data and advises patients

currently taking naproxen to carefully follow the instructions on the label and

not exceed the recommended dose (220 mg twice daily) and do not take for longer

than 10 days, unless directed by your physician.

Find more information at FDA MedWatch.

For additional information:http://www.nih.gov/news/pr/dec2004/od-20.htm