Post by catatonic on Nov 8, 2003 8:47:06 GMT -5
The FDA has concluded that use of Serevent can be life threatening, its manufacturer has halted its tests on the drug, and all patients currently using Serevent are urged to visit their doctors and replace this medication with something safer.
Among the scary findings: "a trend toward increased risk of life-threatening asthma episodes or asthma related deaths".
A copy of the letter GalaxoSmithKline will be sending to all Serevent users urging them to stop using the drug can be found at www.fda.gov/medwatch/SAFETY/2003/serevent.htm
The full text of the FDA's "Med Watch" summary and warning is below:
The Serevent Multicenter Asthma Research Trial (SMART) was conducted to further investigate the safety of Serevent (salmeterol) a long-acting â2-agonist, following concerns about regular use of short and long-acting â2-agonists in the management of asthma. The primary endpoint of the study was the combined number of respiratory-related deaths and respiratory-related life-threatening experiences. Although interim analysis did not demonstrate a significant difference for the primary endpoint, a trend toward increased risk of life-threatening asthma episodes or asthma related deaths with Serevent was found when all patients were considered. The manufacturer, GlaxoSmithKline (GSK) states it stopped the study early because of problems with enrollment and the improbability of obtaining a clear conclusion due to the low overall rate of primary events. The FDA has emphasized that the benefits of therapy far outweigh the risks and firmly advises patients to continue their therapy with Serevent until they are able to consult with their physician. Any adverse event information associated with Serevent should be forwarded to GSK at 1-888-825-5249 or directly to the FDA at 1-800-FDA-1088. Visit the FDA website for a copy of the Dear Healthcare Professional letter: www.fda.gov/medwatch/SAFETY/2003/serevent.htm
Among the scary findings: "a trend toward increased risk of life-threatening asthma episodes or asthma related deaths".
A copy of the letter GalaxoSmithKline will be sending to all Serevent users urging them to stop using the drug can be found at www.fda.gov/medwatch/SAFETY/2003/serevent.htm
The full text of the FDA's "Med Watch" summary and warning is below:
The Serevent Multicenter Asthma Research Trial (SMART) was conducted to further investigate the safety of Serevent (salmeterol) a long-acting â2-agonist, following concerns about regular use of short and long-acting â2-agonists in the management of asthma. The primary endpoint of the study was the combined number of respiratory-related deaths and respiratory-related life-threatening experiences. Although interim analysis did not demonstrate a significant difference for the primary endpoint, a trend toward increased risk of life-threatening asthma episodes or asthma related deaths with Serevent was found when all patients were considered. The manufacturer, GlaxoSmithKline (GSK) states it stopped the study early because of problems with enrollment and the improbability of obtaining a clear conclusion due to the low overall rate of primary events. The FDA has emphasized that the benefits of therapy far outweigh the risks and firmly advises patients to continue their therapy with Serevent until they are able to consult with their physician. Any adverse event information associated with Serevent should be forwarded to GSK at 1-888-825-5249 or directly to the FDA at 1-800-FDA-1088. Visit the FDA website for a copy of the Dear Healthcare Professional letter: www.fda.gov/medwatch/SAFETY/2003/serevent.htm
