Advil / Ibuprofen

ADVIL (Ibuprofen)

Manufacturer: Wyeth

Ibuprofen is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It is an over the counter drug primarily used to reduce the fever, pain, inflammation, and stiffness caused by many conditions, such as osteoarthritis, rheumatoid arthritis, and abdominal cramps associated with menstruation. Children's Advil is an over the counter drug primarily used to reduce fever in children.

FDA NSAIDs Decision Memo

SUBJECT: Analysis and recommendations for Agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk

Executive Summary

Following a thorough review of the available data we have reached the following conclusions regarding currently approved COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs)1 and the risk of adverse cardiovascular (CV) events:2

• The three approved COX-2 selective NSAIDs (i.e., celecoxib, rofecoxib, and valdecoxib) are associated with an increased risk of serious adverse CV events compared to placebo. The available data do not permit a rank ordering of these drugs with regard to CV risk.

• Data from large long-term controlled clinical trials that have included a comparison of COX-2 selective and non-selective NSAIDs do not clearly demonstrate that the COX-2 selective agents confer a greater risk of serious adverse CV events than non-selective NSAIDs.American Osteopathic College of Dermatology, 2004  Erythema Multiforme   However many drugs are trigger factors and a strong causative link has been found between antibiotics (especially sulfa drugs and penicillin's), NSAID's (drugs like Advil, Motrin and Naprosyn) and anti seizure medications (especially Dilantin and Phenobarbital).

By The Washington Post  |  January 2, 2007  FDA proposal stresses caution on painkillers

By Ricado Alonso-Zaldivar,Dec 2006    Stronger warnings urged for painkillers     The FDA wants consumers to be aware that using over-the-counter drugs carries risk

WNDU 16 Health Resource Dec 2006     FDA Calls for Stricter Medicine Warnings

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