The U.S. Food and Drug Administration (FDA) has said that it is seeking additional information from drug manufacturers about their asthma products such as GlaxoSmithKine’s Serevent and Advair, Novartis AG’s and Schering Plough’s Foradil and Astrazeneca’s Symbicort regarding the safety of these drugs on children.

Are stricter warnings needed?

According to a recent CNN article, these drugs, referred to as long-acting beta antagonists, are used to prevent long term asthma. While they currently have strict warnings stating that use of the drugs “may increase the risk of asthma-related death”, the FDA believes that even stricter warnings may be needed – particularly for children under the age of 12. The current warnings were added last year after the FDA’s Pediatric Advisory Committee recommended them. Before deciding whether to include stricter warnings, the FDA has said that it wants to collect additional information from the manufacturers on their clinical studies.

Drug information

• Serevent: Manufactured by GlaxoSmithKline, Severent (salmeterol xinafoate inhalation powder) is breathed into the lungs, where microscopic particles are inhaled and cause air passages to relax. The product’s website, www.serevent.com, currently warns that “In patients with asthma, medicines like SEREVENT may increase the chance of asthma-related death.”
• Advair: Also manufactured by GlaxoSmithKline, Advair (fluticasone propionate and salmeterol inhalation powder) controls airway constriction and inflammation. The product’s website, www.advair.com, currently warns that “In patients with asthma, medicines like salmeterol may increase the chance of asthma-related death.”
• Foradil: Manufactured by Novartis AG and Schering Plough, Foradil (formoterol fumarate inhalation powder) is prescribed for asthma and chronic obstructive pulmonary disease (COPD). The product’s website, www.foradil.com, also warns of the possibility of asthma related death.
• Symbicort: Manufactured by Astrazeneca, Symbicort (budesonide/formoterol fumarate dihydrate inhalation aerosol) controls airway constriction and inflammation. This product’s website, www.symbicort.com, also warns of the possibility of asthma related death.

Next steps

The FDA has said that it will take several months to obtain the information needed to determine whether stricter warnings are needed and that the results will be announced via its website, www.fda.gov/.