Archive for the 'Defective Drugs' Category

Zyprexa warnings not sufficient

Wednesday, November 19th, 2008

Labels on the antipsychotic drug Zyprexa don’t warn patients of all its potential side effects.

That’s according to the FDA which says it is looking into requiring the drugs’s manufacturer, Eli Lilly,  to include information about some of the drug’s more recently publicized risks and adverse effects such as weight gain, in children, hyperglycemia, and other metabolic effects.

While Zyprexa—a potent brain tranquilizer that calms hallucinations related to schizophrenia and bipolar mania—is only approved for the treatment of schizophrenia and bipolar disorder, it was marketed for use in milder cases of bi-polar disorder and for dementia.

Also, internal Lilly documents and e-mail messages confirm Lilly marketed Zyprexa off-label. It was later found that Zyprexa can cause severe weight gain and an increase in blood sugar in many patients.  According to the American Diabetes Association, Zyprexa is likelier to cause diabetes than most other medicines for schizophrenia and bipolar disorder.

Last month, Lilly, in its ongoing Zyprexa scandal, agreed to pay $62 million to 32 states and Washington, D.C. to settle claims it improperly marketed Zyprexa.  CNN reported in an earlier release that, since 2005, Lilly has paid out over $1 billion in liability claims connected to Zyprexa.  CNN also pointed out that Lilly faces more problems, including a civil and criminal investigation led by federal prosecutors in Philadelphia.

Pre-emption argument seems headed for narrow drug company victory

Tuesday, November 4th, 2008

Watchers of the U.S. Supreme Court seem to agree that the high court will likely rule in favor of a drug manufacturer in a case that saw a Vermont woman loose her arm to gangrene.

However, consumer advocates appeared relieved that the case will affect only situations where there were no allegations that drug companies tried to hide information about potential risks and where the FDA rejected stronger label warnings.

The case, Wyeth v. Levine, has been billed as a major milestone in an effort by the pharmaceutical and other industries to free themselves of unpredictable state court personal injury litigation by embracing instead a single federal regulatory regime — in short, federal pre-emption of state courts.

In 2000, Vermont guitarist Diana Levine went to a clinic seeking relief for her migraine. She was injected with the Wyeth drug Phenergan by means of an intravenous method that was discouraged but not forbidden by the labeling, which had been approved by the Food and Drug Administration.

But based on arguments before the high court Monday, the case could be decided narrowly, giving little guidance about broader pre-emption issues beyond the area of drug labeling.

Chantix users could suffer seizures

Tuesday, November 4th, 2008

If you’re driving and you black out or have a seizure, you’ll likely have a car wreck.

That makes sense, of course, but you might not be aware that one of the side effects of the smoking cessation drug Chantix is patients could unexpectedly have a seizure and black out.

Since the drug was approved for use in early 2006, Chantix users reported more than 1,000 seizure incidents. Of those, 52 caused the individual to black out momentarily.

Other side effects of Chantix include suicidal thoughts and tendencies and, allegedly, 40 suicides, though there have been no conclusive link discovered. However, the FDA is considering modifying the drug’s label to include the risk of developing seizures.

Patients who have suffered from either of the drug’s side effects should not only discontinue use of Chantix, but may also wish to speak with their doctor as well as an experienced Chantix attorney on the development of litigation.