Friday, August 17, 2007

Black Box Warnings for Avandia and Actos

Article on cnn.com --  Avandia, Actos to include 'black box' warnings, by the Associated Press.  Here's an excerpt:

The diabetes drugs Avandia and Actos will be labeled with severe warnings about a risk of heart failure to some patients, health officials said Tuesday.

The makers of the drugs, GlaxoSmithKline Plc and Takeda Pharmaceutical Company Ltd., have agreed to add the "black-box" warnings, the Food and Drug Administration said. The warnings, the most severe that prescription drugs can bear, stress the medicines may cause or worsen heart failure and that patients should be closely monitored.

The warnings also apply to combination drugs that include the active ingredients in Avandia, made by Glaxo, or Takeda's Actos. The drugs help patients with Type 2 diabetes control their blood sugar levels.

BGS

August 17, 2007 in Avandia, FDA | Permalink | Comments (0) | TrackBack (0)

Wednesday, August 15, 2007

Ford Recalls 3.6 Million Vehicles For Faulty Cruise Control Switch and Possible Fire Risk

Article on cnn.com --  Ford recalling millions of vehicles because of faulty switches.  Here's an excerpt:

Two years after his wife of 34 years died in a fire, an Iowa man continues to maintain the blaze was started by a faulty cruise control switch under the hood of her 1996 Ford F-150 pickup -- while it was parked in the garage attached to his home.

Although Ford has denied -- and continues to deny -- the switch started the fire that killed 74-year-old Dolly Mohlis in 2005, the company recently settled a lawsuit brought against it by Earl Mohlis. And last week, it issued a recall of an estimated 3.6 million vehicles -- bringing the total recalled over the past decade to more than 10 million -- every single car and truck built with a similar cruise control switch.

BGS

August 15, 2007 in Vehicles | Permalink | Comments (1) | TrackBack (0)

Monday, August 13, 2007

FDA Accuses Pfizer of False Advertising for Anti-Psychotic Drug Geodon

Article on cnn.com -- FDA accuses Pfizer of false advertising: Pfizer's ad for anti-psychotic drug misleading, with health risk info missing, says FDA, by Aaron Smith.  Here's an excerpt:

The FDA on Monday accused Pfizer of false advertising for its anti-schizophrenia drug Geodon.

The Food and Drug Administration, in a letter posted on its Web site, said that a Pfizer (down $0.10 to $23.89, Charts, Fortune 500) advertisement appearing in a medical journal "is false or misleading because it omits important risk information and contains unsubstantiated superiority claims."

The FDA said that Pfizer omitted health risks that have been attributed to the injectable drug Geodon, including diabetes, high blood pressure and neurological disorders.

The FDA said that Pfizer used the term "movement disorders" to refer to a disorder called tardive dyskensia, a description that is "insufficient" to communicate its seriousness.

BGS

August 13, 2007 in FDA, Pharmaceuticals - Misc. | Permalink | Comments (1) | TrackBack (0)

Sunday, August 12, 2007

Richard Epstein on the Williams Punitive Damages Case

As I've posted before, there is an upcoming symposium on September 7 at at Charleston Law School in South Carolina on Punitive Damages, Due Process, and Deterrence: the Debate After Philip Morris v. Williams Download charleston_law_school_conference_brochure.pdf.  In advance of that conference, I thought I'd link Richard Epstein's interesting February 2007 Federalist Society audio commentary on the Williams case.

BGS

August 12, 2007 in Punitive Damages, Tobacco | Permalink | Comments (0) | TrackBack (0)