(2003; 13 pages)
SALMETEROL - Risk of life-threatening asthma episodes
USA. The US FDA is advising that all drug products containing salmeterol will now include new safety information and warnings about a small but significant number of reports of life-threatening asthma episodes or asthma related deaths in patients taking these products. Salmeterol is a long-acting bronchodilator used to treat asthma and chronic obstructive pulmonary disease (COPD). The FDA announcement follows the findings of a large safety study in the US showing a significant increase in respiratory-related death or life-threatening experience in African-American patients treated with the drug (Serevent). However, the FDA emphasizes that based on available data, the benefits of treatment with salmeterol in patients with asthma and COPD continue to outweigh the potential risks when used according to the instructions contained in the product labelling. Patients should not stop taking products that contain salmeterol, or any other medication for asthma or COPD without consulting their physicians since abrupt discontinuation of therapy can result in worsening of the disease with serious and fatal consequences.
FDA Talk Paper, 14 Aug 2003. Available from URL: http://www.fda.gov