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Asthma Drugs Under Fire for Decades

The history of asthma medicine is a tale of woe and intrigue. In the 1960s there was a surprising increase in deaths from asthma over previous decades, especially in Australia and England.

Many patients were found dead with their inhalers clutched tightly in their hands. Experts blamed the deaths on high doses of a bronchodilator called isoproterenol. This drug opened airways quite effectively, but it also increased heart rate and triggered potentially fatal heart rhythms.

The United States appears to have escaped that epidemic of asthma deaths largely because isoproterenol was available only at much lower doses.

Americans escaped another asthma tragedy in the 1970s. A new asthma drug was introduced in New Zealand in 1976 called fenoterol. It was a more potent asthma inhaler also designed to open airways. The trouble was that the more people used fenoterol, the more asthma deaths occurred (Thorax, Feb. 1991).

This observation, along with similar episodes in Canada, led some physicians to wonder whether drug therapy might be part of the problem rather than the solution (Medical Clinics of North America, July 1996).

Fast forward to 2008. The mainstays of asthma treatment these days still involve bronchodilators. These drugs open constricted airways during an asthma attack. They work on the same principle as the old drugs of the 1960s and 1970s.

But drug companies always like an edge. They have created longer-acting bronchodilators with twice-a-day dosing. Instead of puffing on an inhaler like albuterol every four to six hours, patients use drugs like Serevent and Foradil every twelve hours.

The convenience was supposed to be beneficial, but some researchers now question the safety of these long-acting puffers. After reviewing data from 110 clinical trials involving more than 60,000 patients, FDA safety officials concluded that these drugs are linked to higher rates of asthma-related hospitalizations and deaths.

How paradoxical. The very medicines intended to open airways and improve breathing appear to be contributing to complications. The FDA staffers who reviewed the data recommended banning Serevent and Foradil for treating asthma.

Some agency safety experts even advocated banning all long-acting bronchodilators for children. That includes combination drugs like Advair and Symbicort. These inhalers contain steroids that are intended to calm inflammation along with the bronchodilators.

The manufacturers maintain that adding a steroid reduces the danger from bronchodilators. Safety reviewer Andrew Mosholder, MD, counters that there is inadequate evidence to show that adding steroids eliminates the risk.

An FDA advisory panel of outside experts recently voted to ban both Foradil and Serevent for use in asthma, but suggested that Advair and Symbicort should remain on the market. Despite this recommendation, some panel members called for further research on the long-term safety of these combination drugs.

All this controversy means that people with breathing problems, whether due to asthma or chronic obstructive pulmonary disease (COPD), face a difficult dilemma. Even after 40 years, questions remain about the safety of some of their medications.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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