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Serevent Should Have Stronger Warnings About Fatal Side Effects in Children, FDA Panel Says

Nov 29, 2007 | Parker Waichman LLP

Serevent, a top selling asthma drug, needs stronger safety warnings, a Food & Drug Advisory (FDA) panel said yesterday.  The FDA panel's Serevent recommendation came after five children died while using the drug.  If adopted, the new warnings could have serious implications for Serevent sales, and for those of another GlaxoSmithKline asthma medication, Advair.   Serevent is an active ingredient in Advair.

Serevent and Advair are inhalation powders used to prevent asthma attacks.  Asthma is a chronic lung disease that causes inflammation and narrowing of the airways in the lungs.   Asthma attacks cause shortness of breath, cough, chest pain and other symptoms.  Serevent and Advair contain long-acting beta 2-adrenergic agonists that prevent the release of substances in the body that cause inflammation of airways in the lungs.  Both Serevent and Advair are used to prevent asthma attacks, and do not work if an asthma attack has already begun. Advair and Serevent are also used to treat chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis.

The FDA advisory panel met yesterday to review nine new adverse event reports involving pediatric Serevent patients.  Those reports included five deaths over a period of about a year.  The panel also looked at several others studies that indicated increased hospitalizations and deaths in children using Serevent.  Panel members were obviously disturbed by the Serevent side-effect reports, with two panel members arguing that Serevent should actually be pulled from the market. "The data is very troubling because both the increase in hospitalization and in mortality is so different" from what doctors currently believe, said panel member Thomas Newman, an epidemiologist at the University of California, San Francisco.

Serevent problems first came to light a few years back.   Consumer group Public Citizen lists both Serevent and Advair on its "worst drugs" list.  Since the fatal side effects where first reported, Serevent sales have plummeted, but Advair is still a blockbuster for Glaxo.

The FDA will consider the safety of other drugs in Serevent's class, including Advair, at a future advisory panel meeting.  It is theorized that a steroid used as an ingredient in Advair, but not Serevent, provided protection against serious complications, but the FDA panel rejected that notion, saying there was no real evidence to support it.

In 2005, the FDA strengthened the warning labels for Serevent and Advair, as well as Foradil, a similar drug made by Novartis AG, warning that these asthma drugs should be reserved for patients who did not respond to other asthma therapies.  The label changes came after a study found that patients taking Serevent where four times more likely to suffer an asthma-related death.  Others showed that Serevent and Foradil increased asthma exacerbations and hospitalizations in both adults and children.

In a statement, GlaxoSmithKline said that it remained confident that Serevent and Advair are safe drugs, and their benefits outweigh any risks.  Serevent and Advair are the second best-selling medications in the world, with sales of more than $6 billion.

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