Some Asthma Drugs Too Risky, FDA Told

WASHINGTON (Dec. 11) - Government health advisers Thursday called for restrictions on some long-acting asthma drugs, but spared Advair, a top-selling medication used by millions of patients.

Outside experts advising the Food and Drug Administration recommended that Foradil and Serevent no longer be used for asthma. But they said the benefits of Advair and Symbicort clearly outweigh the risks.

All the medications contain an ingredient that relaxes muscles around stressed airways. But that may mask symptoms that can trigger life-threatening asthma attacks. Advair and Symbicort contain a second ingredient that reduces inflammation inside breathing passages and may help patients avoid such problems.

The FDA's own drug safety experts had recommended restrictions on all four drugs, including that none of them be used to treat asthmatic children. But the agency's respiratory specialists said the risks were manageable and no curbs were needed.

With its own experts deadlocked, the FDA called in an unusually large panel of 27 outside advisers. The medical and scientific experts said Advair and Symbicort should continue to be used with all patients, including children. The vote on Advair was 27-0; on Symbicort it was 26-0. On Foradil nine voted "yes" and 18 said "no," with a "no" vote meaning the risks were greater than the benefits. For Serevent the vote was 10-17.



The FDA usually follows the recommendations of its outside experts.
About 22 million people in the United States suffer from asthma, which claims nearly 3,600 lives. Children account for nearly one out of every three patients. An FDA analysis showed that the risks of long-acting asthma medications were greater in children.

The four medications contain a kind of drug called a long-acting beta agonist, or LABA. It relaxes the muscles around stressed airways to help patients breathe.

In recent years, millions of asthma patients have turned to the long-acting drugs to help them breathe more normally, allowing adults to get nights of uninterrupted sleep, and kids, for instance, to join a soccer team. Advair dominates the market, with almost 4 million patients.

But in rare cases, the drugs can increase the risk of serious asthma complications and send patients to the emergency room gasping for air.

Some experts believe that using a LABA alone can mask developing symptoms, and unexpectedly get patients in trouble. That's why treatment guidelines call for LABA medications to be used with a steroid. Asthma patients also carry a "rescue" inhaler for emergencies.

Bottom line: Unless it is ABSOLUTELY NECESSARY, do not pump your body full of drugs, especially steroids, as they can kill you.

If you suffer from severe asthma, emergecy inhalers are far safer and more efffective than prophylactic steroids.