Bayer Halts U.S. Sale of Trasylol

[Guest guest]

Reposting -

article from the 'CBG - Coalition against BAYER Dangers' organization's

newsletter

_http://www.cbgnetwork.org/4.html_ (http://www.cbgnetwork.org/4.html)

 

 

 

November 5, 2007; Wall Street Journal

 

Bayer Halts U.S. Sale of Trasylol

_http://www.cbgnetwork.org/2210.html_ (http://www.cbgnetwork.org/2210.html)

 

 

Bayer AG will pull its antibleeding drug Trasylol from the U.S. market amid

growing evidence it may be linked to a higher risk of death than that of

competing drugs, according to people with knowledge of the matter.

 

It wasn't clear late yesterday if Bayer, based in Germany, would halt sales

of the drug in other countries, although such a move would be likely in light

of a suspension of U.S. sales.

 

Trasylol, which is supposed to reduce blood loss and allow patients

undergoing heart-bypass surgery to avoid transfusions, would be the third drug

this

year whose sale in the U.S. was halted under scrutiny from the Food and Drug

Administration, a signal of how the agency is weighing safety issues heavily

in drug decisions. Still, the history of Trasylol, which was approved in the

U.S. in 1993 and has been tied to high-profile safety concerns at least since

early 2006, is likely to draw questions from Congress and plaintiff

attorneys.

 

The drug had world-wide sales of $338 million in 2005. Sales dropped by

about a third last year.

 

Last month, after a Canadian clinical trial stopped enrolling patients to

take the drug because it appeared linked to a higher risk of death, the FDA

said it was reviewing Trasylol.

 

The drug's safety became a high-profile issue with the publication of a

study in the New England Journal of Medicine in January 2006, which found the

drug might be linked to a doubled risk of kidney failure, as well as increased

risk of heart attacks, heart failure and strokes. The authors concluded

" continued use is not prudent " and said two generic medications were safe

alternatives. However, the study didn't involve patients being randomly

assigned to

take the drug.

 

The FDA put out a notice about Trasylol in February 2006, urging doctors to

closely monitor patients taking the drug. In September 2006, an agency

advisory committee voted unanimously that the drug should remain on the market.

After the meeting, the FDA said a safety study commissioned by Bayer hadn't

been

submitted to the agency in time to be reviewed by the committee.

 

The FDA made changes to Trasylol's label in December 2006, including a

warning about potential kidney damage and a narrowing of the recommended

population of patients.

 

In September, another advisory committee examined the drug, this time

including the Bayer study, which suggested Trasylol might be tied to a higher

risk

of death and kidney damage. A follow-up to the earlier New England Journal

study, this one published in the Journal of the American Medical Association in

February, also tied Trasylol to mortality risk, and it advised that its use

" does not appear prudent. " Still, none of the safety studies were randomized.

 

The committee still voted, 16-1, that Trasylol remain on the market. Some

doctors argued that the drug filled an important niche for patients who

couldn't handle blood transfusions.

 

Finally, late last month, the FDA announced the new review in the wake of

the early findings from the randomized Canadian trial, which suggested Trasylol

" increases the risk of death " compared to the risk from other drugs, the

agency said. (Anna Wilde Mathews)

 

 

 

Further information:

 

· Bayer apologizes to FDA panel on Trasylol data:

_www.cbgnetwork.de/2099.html_ (http://www.cbgnetwork.de/2099.html)

 

· Bayer failed to report risks of drug: _www.cbgnetwork.de/1639.html_

(http://www.cbgnetwork.de/1639.html)

 

· Multiple Risks of Surgery Drug Seen: _www.cbgnetwork.de/1316.html_

(http://www.cbgnetwork.de/1316.html)

 

Coalition against BAYER Dangers (Germany) _www.CBGnetwork.org_

(http://www.CBGnetwork.org)

_CBGnetwork_ (CBGnetwork)

Fax: (+49) 211-333 940

Tel: (+49) 211-333 911

please send an e-mail for receiving the English newsletter Keycode BAYER

free of charge. German/Italian/French/Spanish newsletters also available.

 

Advisory Board

Prof. Juergen Junginger, designer, Krefeld,

Prof. Dr. Juergen Rochlitz, chemist, former member of the Bundestag,

Burgwald

Wolfram Esche, attorney, Cologne

Dr. Sigrid Müller, pharmacologist, Bremen

Eva Bulling-Schroeter, member of the Bundestag, Berlin

Prof. Dr. Anton Schneider, biologist, Neubeuern

Dorothee Sölle, theologian, Hamburg (died 2003)

Dr. Janis Schmelzer, historian, Berlin

Dr. Erika Abczynski, pediatrician, Dormagen

 

 

This email was cleaned by emailStripper, available for free from

_http://www.papercut.biz/emailStripper.htm_

(http://www.papercut.biz/emailStripper.htm)