Safety Announcement [01-20-2012] The U.S. Food and Drug Administration (FDA) is informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). PML is a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or
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Pharmalot by Ed Silverman — In a defeat for Johnson & Johnson, a federal judged ruled the drugmaker will have to defend against lawsuits charging it failed to properly warn that its over-the-counter Motrin pain reliever can cause Stevens-Johnson Syndrome and a deadlier form of the disease known as Toxic Epidermal Necrolysis. The judge refused
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Bloomberg by Alex Nussbaum – House Democrats called for congressional hearings on a gastric band made by Allergan Inc. and transvaginal meshes of the kind made by Johnson & Johnson, saying the devices are hazardous to patients. U.S. Representative Henry Waxman, a California Democrat, and three colleagues urged Republicans who control the House Energy and
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California Watch by Erica Perez – A watchdog group is calling on the Food and Drug Administration to throw out a joint committee’s vote in support of a controversial oral contraceptive because four members of the committee – including a Stanford University professor of obstetrics and gynecology – had ties to the maker of the
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Parmalot by Ed Silverman — One month after Novartis initiated an investigation into a death tied to its new Gilenya pill for multiple sclerosis, the European Medicines Agency has now launched its own probe after receiving reports of up to 11 deaths among patients who took the medication. This includes the first death that the
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Pharmalot by Ed Silverman – – Just one week after a closely watched trial began in an Austin, Texas, courtroom, Johnson & Johnson has agreed to pay $158 million to settle a lawsuit filed by the state attorney general, who charged the Janssen pharmaceutical unit orchestrated a controversial program that was allegedly designed to boost
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Asbury Park Press by Michael Diamond – - A Johnson & Johnson subsidiary sold more than a dozen types of orthopaedic devices without getting the necessary approval from regulators, the U.S. Food and Drug Administration said in a warning letter released this week. DePuy Orthopaedics Inc., based in Warsaw, Ind., also had a quality system that didn’t comply
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WASHINGTON (Reuters) – Florida drugstore chain Rexall Inc is recalling softgel vitamins because their mislabeled bottles contain tablets made from crustacean shells, a potential allergen, the company said. Rexall’s Calcium 1200 mg plus 1000IU Vitamin D3, 60 softgels are actually in bottles holding Triple Strength Glucosamine Chondroitin and MSM Tablets, the company said in a
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In December 2011, a U.S. Food and Drug Administration (FDA) advisory panel voted 15-11 that the benefits of drospirenone-containing birth control pills, such as Yaz and Yasmin, outweigh the risks. Interestingly, though, an investigation by the Washington Monthly and the British Medical Journal (BMJ) found that at least four members of the committee have either done work for the drugs’
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(January 17, 2012) Los Angeles Times – – Nearly 89,000 Mini brand cars, including the Mini Cooper line of vehicles, are being recalled in the U.S. because of faulty water pumps that can malfunction and potentially cause engine compartment fires. The recall comes about three months after the National Highway Traffic Safety Administrationopened a defects investigation,
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on Florida’s Rexall recalls vitamins over shellfish fearsIt took me time to learn all the comments, but I honestly loved the blog. It proved to be very
on Roche Faces First Trial of Claims Over Raptiva InfectionsVivian this is David Ennis and thank your for your reply. We have our own facebook, twitter and youtube page.
on J&J Pays $158M To Settle Risperdal Lawsuit In TexasRisperal reproached. Same saga here as Eli Lilly Zyprexa. Johnson and Johnson is a trusted brand we associate with babies.
on Roche Faces First Trial of Claims Over Raptiva Infectionsi love your blog, i have it in my rss reader and always like new things coming up from it.
