Category Archives: Pharmaceuticals

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The US Food & Drug Administration is Looking into Whether Morning-After Emergency Contraceptive Pills Fail to Work in Women Over a Certain Weight

The FDA quickly addressed a recent report that European health regulators have ordered a label change on an emergency contraceptive product sold by French drugmaker HRA Pharma under the brand name Norlevo(levonorgestrel). The European authorities now require the drug’s labeling to address the potential that there is diminishing effectiveness of the pill depending upon the weight of the user. According to HRA, the emergency contraceptive begins to lose its effectivness for wormn who weigh more than 165 pounds and is completely ineffective for women…

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Pennsylvania Superior Court Upholds Dismissal of Suit Claiming Paxil Caused Birth Defects

The Pennsylvania Superior Court recently upheld the trial court’s ruling in Thomas v. SmithKline Beecham Corp., 27 Pa.D.&C. 5th 279 (Pa.Commw. Ct. 2012).  Thomas dismissed plaintiff’s wrongful death and survival claims based on her use of the antidepressant drug Paxil during pregnancy as time barred.  She ingested Paxil during her pregnancy and she was subsequently informed in 2001 that a fetal echocardiogram revealed that her fetus had congenital heart defects.  Three days later she chose to undergo a therapeutic abortion at less than…

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This Week’s Life Science Headlines

        Litigation

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This Week’s Life Science Headlines

        Litigation

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Direct Mailers for Aranesp Targeted by FDA

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) recently criticized the makers of Aranesp for a direct mailer that was allegedly in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, the mailer was found to be false or misleading because it omitted important risk information, suggested use beyond that which was substantiated, made unsubstantiated efficacy claims, and omitted material facts. OPDP also found that the mailer evidenced that Aranesp was intended for a new…

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Newly Released Study Links Glaucoma to Long-Term Use of Oral Contraceptives

Building upon data secured from the Centers for Disease Control and Prevention, an international team of researchers has concluded that women who have used birth control pills on a long-term basis are twice as likely to have glaucoma, a leading cause of blindness in the United States. Glaucoma is caused by increased fluid pressure on the eye, resulting in irreversible damage to the optic nerve. Glaucoma usually affects patients who are middle-aged and older, and has no known cure. Scientists from the University of California,…

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This Week’s Life Science Headlines

        Litigation

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FDA Rule Proposal Could Lead to Liability for Generic Drug Manufacturers

The U.S. Food and Drug Administration (FDA) is proposing new rule changes that would permit generic drug manufacturers to amend drug warning labels when they receive new information related to drug safety; irrespective of whether the revised labeling differs from the brand name manufacturer. The proposed rules further provide that the generic manufacturer would be required to submit the labeling changes along with the data supporting the change to the FDA, which would review the request and post the data in a public web page.…

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Despite Reported Risks, Side Effects and Threatened Litigation, Crestor Top Selling Drug

According to a report by the research firm IMS Health, (free membership login required) new prescriptions and refills for Crestor, a drug used to lower cholesterol, exceeded all other prescribed drugs in the United States between October 2012 and September 2013. Crestor (rosuvastatin), like Lipitor (atorvastatin) is widely-used to lower cholesterol and belongs  to a family of drugs called “statins.” Among the best-selling drugs in the United States, statins use the liver to block the body’s creation of cholesterol, which is a key contributor…

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