Harmful Drug Exposure

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Harmful Drug Exposure news feed.

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 >>]

FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor Celebrex

December 17th, 2004. (Press Release) The FDA today released the following statement on the halting of a clinical trial of the Cox-2 inhibitor Celebrex (celecoxib): The Food and Drug Administration (FDA) learned last night from the National Cancer Institute (NCI) and Pfizer, Inc., that NCI has stopped drug administration in an ongoing clinical trial ... [More >>]

Merck & Co., Inc. Response to an Editorial Posted on the New England Journal of Medicine Web Site

December 8th, 2004. In response to an editorial that appeared today on the New England Journal of Medicine website, Merck & Co., Inc. believes that it is important to emphasize that the company promptly and appropriately disclosed the results of the VIGOR (VIOXX Gastrointestinal Outcomes Research) study. Merck correctly communicated about the benefits ... [More >>]

Vioxx drug recall; pain and arthritis drug shown to increase risks of stroke, heart attack

September 30th, 2004. Results of a recent study on Vioxx confirmed long-standing concerns that the drug increases the risk of stroke and heart attack, spurring maker Merck to voluntarily pull the drug worldwide (in some countries, the drug is marketed under the name "Ceoxx"). Vioxx is regularly prescribed for treatment of arthritis and acute ... [More >>]

FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product

September 30th, 2004. (Press Release) The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with ... [More >>]

Merck Announces Voluntary Worldwide Withdrawal of VIOXX®

September 30th, 2004. Merck & Co., Inc. today announced a voluntary worldwide withdrawal of VIOXX® (rofecoxib), its arthritis and acute pain medication. The company's decision, which is effective immediately, is based on new, three-year data from a prospective, randomized, placebo-controlled clinical trial, the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial. The trial, which ... [More >>]

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Last Updated: February 05, 2008. 10:53:35 am

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