FaultyDrugs.com » Deaths

Epoetin alfa- Preliminary Safety Findings points out to Deaths

Admin — Tue, 18 Nov 2008 08:57:02 +0000

FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product. Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%). Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group.

FDA anticipates the receipt of additional data within the next several weeks. As soon as the review of these data is complete, FDA will communicate our conclusions and recommendations to the public. The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.

FDA recalls Zyprexa

Admin — Sun, 27 Jul 2008 08:45:15 +0000

Zyprexa was FDA approved for the short-term treatment of acute manic episodes in bipolar disorder. The worlds best selling schizophrenia drug, Zyprexa sales account for 40% of Eli Lillys $11.08 billion in sales. There have been many questions regarding the popular drug Zyprexa and its safety. Linked to 288 reported Zyprexa diabetes cases, including 23 deaths, the Zyprexa concerns were so great that Japan and the European Union required that diabetes warnings be included on Zyprexa labeling.

The Public Citizen consumer group thinks the FDA has not adequately warned physicians and Zyprexa patients of the Zyprexa risks. Hyperglycemia, diabetes, and ketoacidosis have been reported amongst Zyprexa patients. Ketoacidosis, associated to Zyprexa adverse effects reports end up fatal in about 50% of the cases. The last time the Zyprexa labeling was updated in the U.S. the FDA only made a quick reference to the risk of Zyprexa diabetes and hyperglycemia in the middle of the adverse reactions section of Zyprexa labeling.

Heparin Recall and Deaths

Admin — Sun, 27 Jul 2008 08:26:13 +0000

The FDA was in the hot seat on Capitol Hill after a tainted drug was implicated in multiple deaths. A recent study found that more than 80 percent of active ingredients in U.S. drugs come from abroad, but only 11 percent of foreign suppliers are investigated by the FDA.