FDA Agenda Addresses OTC Medications
Allergy and asthma medications are at the forefront of the U.S. Food and Drug Administration (FDA) agenda this year as the agency considers moving more drugs from prescription to over-the-counter (OTC) status.
Two medications recently considered were Nasacort®, the corticosteroid nasal spray approved for OTC use in late 2013, and Primatene HFA, an OTC asthma bronchodilator still under consideration at this time.
On May 2, FDA’s Nonprescription Drugs Advisory Committee voted 11-4 against an application for OTC montelukast tablets, called Singulair® Allergy. Merck, the drug manufacturer, had proposed to label the product to temporarily relieve symptoms of hay fever and other respiratory allergies in adults 18 years and older.
Montelukast, a leukotriene receptor antagonist currently available by prescription only, was first approved in 1998 for preventive treatment of asthma. Some years later, it was approved to treat allergic rhinitis and to prevent exercise-induced bronchospasm (EIB), and is now available in tablets, chewable tablets and granules, for children as young as 6 months. The proposed OTC use would have only applied to 10 mg tablets for adults.
Allergy & Asthma Network Mothers of Asthmatics (AANMA) testified in opposition to OTC labeling for Singulair.
“The medication has a 15-year history of use for asthma, and if available OTC, there would be no regulations to keep people from buying it for that purpose – with or without a diagnosis – even if it is only labeled for allergy,” says Tonya Winders, AANMA president and CEO. “Asthma is not an over-the-counter disease; it is life-threatening and requires carefully coordinated treatment from qualified health care professionals.
“Singulair also carries a significant warning for possible behavioral side effects, especially for children, and Allergy & Asthma Network is concerned that OTC labels would not address this danger clearly enough.”
Allergy & Asthma Network will also address the issue of switching asthma and life-threatening allergy medications from prescription to OTC status at its 17th annual Allergy & Asthma Day Capitol Hill, May 6-7.