WIS News 10 - Columbia, South Carolina | Health Alert: Questions over asthma drugs

Health Alert: Questions over asthma drugs

(National) July 13, 2005 - Patricia Younger uses the drug Advair to prevent asthma attacks, "It helps a lot because it opens up your air passages and it maintains you most of the day."

Dr. Guilleremo Gutierrez says patients like Advair because they only have to take it twice a day, "The alternatives are equally useful to the patient, but they have to be taken more frequently."

Advair and the drug Serevent both contain Salmeterol. Two-years ago, a clinical trial of Salmeterol was stopped early because some patients' asthma got worse and 13 out of 13,000 died. It's a small number, but three times the number of deaths among patients not using the drug.

Frequent FDA critic Dr. Sidney Wolfe says the drugs shouldn't be used, "Given that the purpose of treating asthma is to prevent people from dying, if a drug increases the death rate, it really shouldn't be used."

Dr. Katharine Knobil with Glaxo Smith Kline, the drug's manufacturer, insists Salmeterol is safe, "We firmly believe that Salmeterol remains a valuable medication that has improved the level of care for patients with asthma and COPD."

Serevent and Advair already have black box warnings on the labels, but another asthma drug, Foradil, does not. A separate trial found asthma flare-ups in patients whose used twice the recommended dose.

The FDA is asking a panel of experts if warnings should be added, changed or if the drugs should be pulled altogether. The FDA's expert panel is recommending these drugs stay on the market, but they want to add a warning to the drug Foradil.

Reported by Dawndy Mercer
Posted 8:44pm by BrettWitt