Archive for April, 2005

FDA Issues Public Health Advisory for Antipsychotic Drugs used for Treatment of Behavioral Disorders in Elderly Patients

April 11th, 2005. (Press Release) The Food and Drug Administration (FDA) today issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning an unapproved (i.e., “off-label”) use of certain drugs called “atypical antipsychotic drugs.” These drugs are approved for the treatment of schizophrenia and mania, but ... [More >>]

FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

April 7th, 2005. (Press Release) The Food and Drug Administration (FDA) today announced a series of important changes pertaining to the marketing of the non-steroidal anti-inflammatory class of drugs, including COX-2 selective and prescription and non-prescription (over-the-counter (OTC)) non-selective NSAID medications. A list of these products is available on the FDA web site. ... [More >>]

New FDA Labeling for Pfizer’s Celebrex and All Other NSAIDs to Reflect Similar Cardiovascular Profile

April 7th, 2005. (Press Release) Pfizer said today it will work with the U.S. Food and Drug Administration (FDA) to add expanded risk information in the Celebrex label following an FDA decision announced this morning to require boxed warnings of potential cardiovascular risk for all COX-2 pain relievers and all NSAIDs, including older non-specific drugs ... [More >>]

Arthritis Drug Bextra Pulled; FDA Requests Revised Label on OTC NSAIDS

April 7th, 2005. What should I do if I am currently taking Bextra? You should speak with your doctor immediately to investigate options to discontinue Bextra and seek alternative treatments. Stevens-Johnson Syndrome In addition to cardiovascular problems, Bextra has been linked to a rare but sometimes ... [More >>]

New FDA Labeling for Pfizer’s Celebrex and All Other NSAIDs to Reflect Similar Cardiovascular Profile

April 7th, 2005. (Press Release) Pfizer said today it will work with the U.S. Food and Drug Administration (FDA) to add expanded risk information in the Celebrex label following an FDA decision announced this morning to require boxed warnings of potential cardiovascular risk for all COX-2 pain relievers and all NSAIDs, including older non-specific drugs ... [More >>]

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