Legal Updates
Antipsychotics Prescribed to Children Under Evaluation
Wednesday, November 19, 2008
On November 18, 2008, a panel of federal drug experts said powerful antipsychotic medicines are being used far too cavalierly in children, and regulators must do more to warn doctors of their substantial risks. More than 389,000 children and teenagers were treated last year with Risperdal, one of five popular…
Johnson & Johnson Pays Millions After Duragesic Patch Death
Tuesday, November 18, 2008
A Chicago jury ruled on November 17, 2008, that subsidiaries of Johnson & Johnson must pay $16.6 million to the family of a woman near Chicago who died of a drug overdose after using a defective Duragesic patch as a pain killer. The woman, 38, died in February 2004 because…
Panel Urges FDA to Update Labels of Facial Fillers
Tuesday, November 18, 2008
On November 18, 2008, a panel of independent advisers urged the FDA to revise the labeling of cosmetic facial fillers to include the possibility of long lasting reactions such as bumps under the skin, blotches and scars."It is almost a no-brainer," said Dr. Michael Bigby, a Harvard Medical School dermatologist.…
Voluntary National Recall of Topical Acne Cream Issued
Tuesday, November 18, 2008
On November 13, 2008, CSI USA, Inc. issued a voluntary nationwide consumer product recall of all lots of 1 ounce (28 g) tubes of 10% Benzoyl Peroxide Acne Cream with the following names: "DG Maximum Strength Acne Medicated Gel" (sold at Dollar General); "Kroger Acne Gel 10% Benzoyl Peroxide Acne…
Zyprexa Faces New FDA Scrutiny
Monday, November 17, 2008
On November 14, 2008, U.S. regulators announced that Eli Lilly & Co.'s antipsychotic Zyprexa should be watched for potential risks in children. The FDA recommended adding a new warning to Zyprexa about the risk of weight gain and other metabolic changes in children, side effects already noted for adults, according…
Lawmakers Want Activis NJ Facilities Shut Down
Monday, November 17, 2008
On November, 14, 2008, U.S. Attorneys in New Jersey filed a lawsuit seeking a shutdown of three Actavis Inc. plants until they are brought into compliance with testing, manufacturing laws and FDA regulations. The complaint requests that the court prevent Actavis Inc., Actavis Totowa, and executives Sigurdur Olafsson and Douglas…
