FDA warns against homeopathic asthma products
SILVER SPRING, Md. — The Food and Drug Administration on Thursday issued a warning to consumers to avoid use of over-the-counter asthma products labeled as homeopathic as "the products have not been evaluated for safety and effectiveness."
The agency directed consumers to talk to their healthcare provider about a prescription asthma remedy or a nonprescription solution that is marketed OTC in accordance with an FDA monograph.
The American Association of Homeopathic Pharmacists, representing the principal manufacturers and distributors of homeopathic medicines in the United States, said it fully supports the Food and Drug Administration’s position that consumers should seek the advice of their health care provider if they suspect they or their children are experiencing symptoms of asthma, which includes, but is not limited to, shortness of breath, chest tightness, wheezing and/or coughing. The AAHP supports the concern that self-treatment of suspected or diagnosed asthma without the advice of a health care provider may place consumers at risk.
"Consumers with diagnosed asthma should seek regular advice from their health care provider for management of intermittent and chronic asthma symptoms," the association stated. "If consumers wish to include homeopathic medicines in their asthma treatment plan, the AAHP suggests consumers seek evaluation by a homeopathic physician who has completed post-graduate medical training in the selection of homeopathic medicines for individual cases."
However, there aren't many OTC medications for asthma on the market. Nephron Pharmaceuticals has a recepinephrine solution on shelves called Asthmanefrin that generated $18.4 million for the 52 weeks ended Dec. 28, 2014, according to IRI data for total U.S. multi-outlets. Sales were relatively flat with a slight 0.8% lift.
And it doesn't look likely that the one-time $100 million asthma-relief brand Primatene Mist will make a comeback to the marketplace. Primatene Mist had been withdrawn from the market in December 2011 when the agency removed all inhalers containing chlorofluorocarbons from the market. And a pair of FDA advisory panels in February of last year did not recommend a petition by Armstrong Pharamceuticals to approve Primatene HFA, an epinephrine inhalation aerosol indicated for the temporary relief of mild symptoms of intermittent asthma for people ages 12 years or older.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program, the agency stated.