Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Monsanto Co. -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (1557)	3/16/1999 5:15:00 PM
From: Dan Spillane	Respond to of 2539

An example of a "safe" European product sold in the US; perhaps they test for safety by submitting products for reviews to the UK tabloids and readers? FDA says Schering division failed to probe drug reactions By Lisa Richwine ROCKVILLE, Md., March 16 (Reuters) - An American unit of German drug maker Schering AG (quote from Yahoo! UK & Ireland: SCHG.F) did not sufficiently investigate serious reactions to three of its products, including one death, the Food and Drug Administration said in a warning letter released Tuesday. The FDA said in a warning letter to Wayne, N.J.-based Berlex Laboratories Inc. that it failed to conduct ''prompt and adequate'' investigations of the cases. In one instance, a patient died after being given the contrast agent Magnevist. Contrast agents are used in diagnostic procedures such as magnetic resonance imaging. The agency sent the letter Feb. 24, one day before it charged Schering, in a similar letter, with delaying reports of serious adverse events in people taking Magnevist and two other drugs. That letter was released by the FDA on March 9. FDA requires drug makers to report serious or life- threatening reactions to their products within 15 days. Warnings letters are the first step in the agency's disciplinary process. Berlex representatives were not immediately available for comment Tuesday. But a company spokeswoman said last week that both Berlex and Schering were working with the FDA to make sure that reporting requirements were followed. The FDA said Berlex had instituted new procedures for handling reports but asked the company to provide specific details about how and when it would make the changes. The FDA also criticized Berlex for not turning over all the information it had about a patient who stopped breathing after being treated with Ultravist, another contrast agent. ''New information on the diagnosis of this medical event was obtained by your firm, but no follow-up report was submitted to include this new information,'' the FDA said in the letter. A third patient taking the drug Betapace, a treatment for irregular heart rhythm, reported unspecified hearing trouble. Berlex should have provided more information about the problem, the FDA said. Berlex also misrepresented certain information when it became aware of the problems, the FDA said. One report was dated three months later than the actual date received, the FDA said in the letter.