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Denture Cream Zinc Poisoning on FDA Radar

February 26, 2011 By

U.S. health regulators have finally weighed in on the risk of zinc poisoning posed by denture creams like Fixodent, and until recently, Super Poligrip. This week, the Food & Drug Administration (FDA) sent a letter to the makers of zinc containing denture creams recommending that they take steps to mitigate the risk of neuropathy and neurological injury posed by overuse of the products.

The FDA letter comes more than two years after the journal “Neurology” published a study linking excessive use of zinc-containing denture creams to neurological injury, and more than a year after scores of denture cream zinc poisoning lawsuits naming the makers of Super Poligrip and Fixodent were consolidated in a mass tort in federal court in Florida.  The FDA action also comes almost exactly a year after GlaxoSmithKline took the zinc out of Super Poligrip products, and Procter & Gamble added a warning about zinc in Fixodent to its website and package label. [Read more...]

Filed Under: Fixodent Zinc Poisoning Neuropathy Tagged With: , , , , ,

All Antipsychotic Drugs to Bear New Pregnancy Caution

February 23, 2011 By

The U.S. Food & Drug Administration (FDA) has mandated that the Pregnancy sections of the labels for the entire class of antipsychotic drugs now include consistent information about the potential risk for EPS and/or withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

Drugs that will bear the new caution include Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, and Symbyax, as well as others. [Read more...]

Filed Under: Defective Drugs Tagged With: ,

Characterization of Breast Implant Lymphoma Risk by Plastic Surgery Groups Sparks Outrage

February 22, 2011 By

Two important professional organizations for plastic surgeons have been accused of telling their members to downplay the breast implant lymphoma risk.  According to Public Citizen, this occurred during a webinar held for members of the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) on February 3, just days after the U.S. Food & Drug Administration (FDA) warned the public about a possible association between breast implants and anaplastic large cell lymphoma (ALCL).

The consumer advocacy group says it was given portions of the webinar’s transcript from a “concerned plastic surgeon.”   According to Public Citizen, here is some of what Dr. Phil Haeck, president of ASPS, advised doctors to tell women about the breast implant-lymphoma connection: [Read more...]

Filed Under: Defective Medical Devices Tagged With: ,

PPIs, Fosamax Not a Good Match, Study Says

February 17, 2011 By

A new study is highlighting another possible problem with proton pump inhibitors (PPIs). They might inhibit the effectiveness of Fosamax and other drugs known as bisphosphonates that are used to treat osteoporosis.

For the “Archives of Internal Medicine” study, researchers observed 38,088 new users of Fosamax (alendronate sodium) for a period of mean duration 3.5 years. The risk for hip fracture was evaluated in relationship to Fosamax refill, based on recent pharmacy records. In Fosamax users who were not taking PPIs concurrently, and who were fully refill compliant in taking Fosamax, there was a 39 percent reduction in hip fractures. However, the same reduction was not seen in those taking both PPIs and Fosamax. [Read more...]

Filed Under: Defective Drugs, Fosamax / Bisphosphonates, Proton Pump Inhibitors

Camp Lejeune Toxic Water Lawsuits Move Forward

February 16, 2011 By

It looks like lawsuits involving tainted water at North Carolina’s Camp Lejeune Marine Corps base will be heard in one jurisdiction.  Earlier this month, the U.S. Judicial Panel on Multidistrict Litigation consolidated all Camp Lejeune toxic water lawsuits in a multidistrict litigation. The lawsuits were transferred to the U.S. District Court, Northern District of Georgia, and will be presided over by Judge J. Owen Forrester.

In a Transfer Order dated February 4, the panel wrote: “It is undisputed that these actions share factual questions arising out of alleged death or injuries due to contaminated drinking water on the Marine Corps Base at Camp Lejeune, North Carolina. Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary.” [Read more...]

Filed Under: Camp Lejeune Toxic Water Tagged With: ,
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