Dec 15 2008 UPDATE –A panel of federal drug experts has decided that asthma medications Serevent and Foradil should be subject to restrictions because they pose a serious health threat to patients if used incorrectly. The medications increase the risk of death unless they are paired with a steroid.
The panel suggested that labels for Foradil and Serevent be rewritten to clarify that they should be used with an inhaled corticosteroid, which is designed to reduce inflammation of the airway. The makers of the drugs, Novartis and GlaxoSmithKline, agreed to the labeling but disapprove of a potential Food and Drug Administration (FDA) decision to prohibit marketing. The FDA recommends that these two drugs not be marketed to children and some adults.
Members of the panel warn patients to consult with their doctor before stopping any asthma treatment. Two other drugs, Advair and Symbicort, were also evaluated. The panel ruled that they aren't subject to the same restrictions.
Dec 09 2008 ORIGINAL ALERT –
The Food and Drug Administration (FDA) officials wrote in a report that asthma patients should no longer take the drugs. A third official said that Advair and Symbicort can be used by adults but that none of the four drugs should be used by people under the age of 17. Other experts say that the risk of death is small, and that banning the drugs could lead to asthmatics relying on other, more dangerous drugs. The FDA analyzed findings from 110 clinical trials involving 61,000 patients.
Sudden deaths among asthmatics still holding their inhalers have sparked the debate, but it has been difficult to determine whether the fatalities were caused by patients’ breathing problems or the inhalers. The FDA will convene a committee of experts to resolve the debate, which has been going on for more than a decade. No matter the committee's decision, however, the drugs will probably remain on the market because the agency’s drug safety officials concluded that they are beneficial to patients suffering from chronic obstructive pulmonary disease, most of whom are elderly.