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FDA Announces Voluntary Withdrawal of Pergolide Products

The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinson’s disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients’ heart valves.  Continue reading ⇒

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DID YOU KNOW THAT THE ORTHO EVRA PATCH MARKETD IN CANADA HAS A LOWER DOSE OF ESTADIOL DUE TO SAFETY CONCERNS?

November 10, 2005 - SOGC Statement

EVRA marketed in Canada has lower estrogen amounts than ORTHO EVRA in the US

On November 10, 2005, the US Food and Drug Administration (FDA) announced new prescribing information for the ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system) birth control patch.  Continue reading ⇒

STUDY FUNDED BY JOHNSON & JOHNSON FINDS A TWO-FOLD INCREASE IN THE RISK OF THROMBOEMBOLISM AMONG ORTHO EVRA USERS

In a study prepared by I3 Drug Safety, a service company for the pharmaceutical industry, the authors found that women using the Ortho Evra birth control were more than twice as likely to suffer venous thromboembolisms than woman using oral birth control. Continue reading ⇒

SUPERVISING JUDGE IN PHILADELPHIA REPLACED

Philadelphia Common Pleas Judge Paul P. Panepinto, who is seeking the GOP nomination for a seat on the state Supreme Court, has been replaced as the judge supervising the Complex Litigation Center. His replacement is Judge Allan L. Tereshko. The next status conference will be in June.

CANADIAN STUDY FINDS A THREEFOLD INCREASE IN THE RISK OF CARIDAIC MALFORMATIONS FROM FIRST TRIMESTER EXPOSURE TO PAXIL

Canadian researchers in study entitled “First Trimester Exposure to Paroxetine and Risk of Cardiac Malformations in Infants: The Importance of Dosage”, Birth Defects Research (Part B) 80:18-27(2007, concluded that women exposed to >25mg /day of Paxil during the first trimester of pregnancy were an increased risk (adj OR = 3.07, 95% CI = 1.00, 9.42) of having a child with cardiac defor Continue reading ⇒

Glaxo Smith Kline data links Paxil to increased risk of birth defects

On December 13, 2005, Glaxo Smith Kline released a follow up to a prior study comparing the effects of bupropion to other antidepressants. The preliminary study and it follow up are available on the GSK website. Continue reading ⇒

COX-2 Selective (includes Bextra, Celebrex, and Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

The Food and Drug Administration (FDA) has issued supplemental request letters to sponsors of all non-steroidal anti-inflammatory drugs (NSAID) requesting that they make labeling changes to their products. These letters include recommended proposed labeling for both the prescription and over-the-counter (OTC) NSAIDs and a medication guide for the entire class of prescription products. Continue reading ⇒

FDA Alert for Practitioners: Celecoxib (marketed as Celebrex)

Celebrex has been associated with an increased risk of serious adverse cardiovascular (CV) events in a long-term placebo controlled trial. Based on the currently available data, FDA has concluded that an increased risk of serious adverse CV events appears to be a class effect of non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin). Continue reading ⇒

Lawsuits of Interest

Accutane  (isotretinoin)
Advair  (Fluticasone/salmeterol)
Avandia  (Rosiglitazone)
Bextra  (Valdecoxib)
Celebrex  (Celecoxib)
Chantix  (Varenicline)
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