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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?


To: VLAD who wrote (10280)6/30/1998 7:04:00 PM
From: Edderd  Read Replies (3) | Respond to of 23519
 
VLAD
Glad to report two new converts to MUSE today. Both Viagra failures but one was because his wife would not let him try Viagra because of the bad publicity. How's that for a new twist on trying MUSE. Both were titrated in the office and were very happy with the result. (500) I hope this is a strong trend. Later I will post a recall on another drug with a lot less incidence of problems than Viagra. Just bad ones.
Ed



To: VLAD who wrote (10280)6/30/1998 7:20:00 PM
From: Edderd  Read Replies (1) | Respond to of 23519
 
Vlad How does this compare with the Viagra scenario?
WYETH-AYERST LABORATORJES
P0. B0X8299, PHILADELPHIA, PA 19101-8299 Division ofAmerican Home Products Corporation



Philipj de Vane, M.D.
Vice President, Clinical Affairs
and Nortb American Medical Director

June22, 1998

Dear Healthcare Professional:

Wyeth-Ayerst Laboratories announced today the voluntary market withdrawal of DURACT~ (bromfenac sodium capsules), a nonsteroidal anti-inflammatory analgesic indicated for the short-term (10 days or less) management of acute pain. The company is taking this action based on postmarketing reports of severe hepatic failure, resulting in four deaths and eight liver transplants.
Approximately 2.5 million prescriptions have been dispensed since DURACT was launched in July 1997. The great majority of those prescriptions were for 10 days or less, a duration of treatment which we continue to believe is safe and effective. All but one of the 12 reported deaths and transplants occurred among the relatively
small percentage of patients who took DURACT for more than 10 days. The exception was a person who had pre-existing significant liver disease.
In February 1998, Wyeth-Ayerst Laboratories and the Food and Drug Administration agreed on labeling changes to further emphasize that DURACT should be used for 10 days or less. These changes were initiated in response to earlier reports of serious hepatic events associated with longer-term use. Alter this action, the number of prescriptions for longer duration use, as well as the number of reported serious hepatic events, was reduced but not completely eliminated. The company has now concluded that further steps to limit use of a potent NSAID analgesic such as DURACT to just 10 days would not be feasible or effective. In light of these circumstances, as well as the availability of other therapies, Wyeth-Ayerst has decided to withdraw this product.
Please discontinue prescribing and dispensing DURACT immediately. You should consider contacting patients who may be taking DURACT for longer than 10 days or who have a history of liver disease. Any such patients should discontinue DURACT treatment. You or your patients may call 1-800-281-9260 with any questions regarding DURACT.
Sincerely,



Philip J. de Vane, M.D.

Isn't that interesting.
Ed