FDA & Prescription Drugs

• Testosterone Gels Get New Black Box Warning

  Jamie Sheller | May 09, 2009 10:16 AM | 0 CommentsPhiladelphia, PA

  Recently, the FDA announced that two testosterone gel products must have a new black box warning. The products are AndroGel 1% from Solvay Pharmaceuticals and Testim 1% from Auxilium...

• New Black Box Warnings Ordered For Botox Products

  Jamie Sheller | May 02, 2009 11:07 AM | 0 CommentsPhiladelphia, PA

  On April 30, 2009, the FDA announced a requirement that Botox and similar products must carry a black box warning on their labels. The new labels must highlight a warning about the risk of a...

• Settlement of Some Magnevist Lawsuits

  Jamie Sheller | April 28, 2009 12:56 PM | 0 CommentsPhiladelphia, PA

  The German drugmaker Bayer has been defending itself against lawsuits over its contrast agent Magnevist. Recently, Bayer agreed to settle some of the cases out of court, without admitting liability....

• Seroquel Should Not Be First Choice For Depression

  Jamie Sheller | April 12, 2009 11:58 PM | 1 CommentPhiladelphia, PA

  Due to its worrisome side effects, federal health experts declared that Seroquel should not be a first choice to treat depression. Seroquel is made by AstraZeneca, and is approved as a treatment for...

• Raptiva Recalled From Market

  Jamie Sheller | April 09, 2009 12:11 PM | 0 CommentsPhiladelphia, PA

  Genentech Inc., has voluntarily withdrawn Raptiva from the market. Raptiva is a psoriasis drug that has been linked to progressive multifocal leukoencephalopathy (PML), a rare brain infection. PML...

• Black Box Warning for Reglan

  Jamie Sheller | March 31, 2009 8:53 PM | 0 CommentsPhiladelphia, PA

  Reglan will soon get a boxed warning of the risks of long term and high dose use, as recently required by the FDA. Reglan is one of a group of drugs containing metoclopramide, which is used to treat...

• Promotion of High-Dose Laxative Leads to Injuries

  Jamie Sheller | March 24, 2009 12:55 PM | 0 CommentsPhiladelphia, PA

  The maker of an oral laxative product faces lawsuits over its promotion of the product. Fleet Phospho-Soda is a laxative made by C. B. Fleet Co., Inc., which is headquarted in Lynchburg, Virginia....

• Newly Released Documents Raise More Questions Over Seroquel

  Jamie Sheller | March 23, 2009 2:04 PM | 0 CommentsPhiladelphia, PA

  In early 2000, Dr. S. Charles Schulz reported to a national medical conference that Seroquel was significantly superior to the old preferred schizophrenia treatment. Dr. Schulz is the chief of...

• "Black Box" Warnings Ordered for Metoclopramide Drugs

  Jamie Sheller | March 12, 2009 6:59 PM | 0 CommentsPhiladelphia, PA

  Some drugs used to treat gastrointestinal disorders will soon have a black box warning. A black box warning is the strongest warning that the FDA requires for drug labels. Metoclopramide is a drug...

• Supreme Court Says No to Implied Preemption

  Jamie Sheller | March 09, 2009 10:43 AM | 0 CommentsPhiladelphia, PA

  In a highly anticipated decision, the United States Supreme Court has ruled that drug manufacturers are not shielded from personal injury lawsuits by implied preemption. The case, Wyeth v. Levine,...