FDA Orders Amgen to Pull TV Ad for Psoriasis Drug
February 21, 2005 07:53 { LA Times }

The Food and Drug Administration demanded Friday that Amgen Inc. pull television ads that the agency said made misleading claims about the company's psoriasis drug, Enbrel.

The Food & Drug Administration has issued a warning regarding a very seriousside effect of Topamax? - generic name Topiramate - an antiepileptic or anticonvulsant drug, prescribed by more than 500,000 physicians to some 825,000 patients over the last four years... (Read Article)

Date: Tue, 8 Feb 2005 16:18:37 -0500
From: CDER MEDWATCH LISTSERV
Subject: FDA MedWatch: ZyPREXA (olanzapine) and ZYRTEC (cetirizine HCI) me dication errors due to name confusion

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Eli Lilly and FDA notified healthcare professionals reports of medication dispensing or prescribing errors between the atypical antipsychotic ZyPREXA (olanzapine), indicated for the short-term and maintenance treatment of schizophrenia and for the short-term treatment of acute mixed or manic episodes associated with Bipolar I Disorder, and the antihistamine ZYRTEC (cetirizine HCI) marketed by Pfizer, indicated for the treatment of allergic rhinitis or chronic urticaria. These reports include instances where Zyprexa was incorrectly dispensed for Zyrtec and vice versa, leading to unnecessary adverse events or potential relapse in patients suffering from schizophrenia or bipolar disorder.

Read the complete MedWatch 2005 safety summary, including links to the Dear Healthcare Professional letter, at http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#ZyPREXA

Patients who rely on painkillers like Bextra and Celebrex are seeking more relief.

They long for a day when they no longer have to worry that their medications will be pulled from the market. One after another, pain sufferers -- most with arthritis -- pleaded Thursday with government advisers to consider their conditions when deciding the fate of so-called Cox-2 inhibitors.

Merck, too. The FDA panel votes to put all of the Cox-2 drugs back on the market with restrictions. A Food and Drug Administration panel's support for Vioxx, Celebrex and Bextra is good news for Merck and Pfizer, but restoring consumers' confidence in the three COX-2 painkillers might be tougher. Merck & Co. Inc. will consider selling its arthritis pill Vioxx again if the U.S. Food and Drug Administration decides the cardiovascular risks are similar to those of related prescription pain relievers, a company official said on Thursday.

http://english.epochtimes.com/news/5-2-17/26493.html

Public Citizen Report Details Donohue's Questionable Performance on Two Corporate Boards WASHINGTON, D.C. - Tom Donohue has a vested interest in the national campaign to limit corporate accountability because the U.S. Chamber of Commerce president sits on... (Read Article)