While each decision must be considered individually, the process may be systematically biased such that risks are overstated and benefits are undervalued. The committee cited the potential for off-label use (e.g., in children and in those with asthma), potential neuropsychiatric adverse effects (e.g., suicide), and labeling too difficult for the average adult to understand.ĭespite the FDA’s implicit desire to make prescription-only medications more readily available, its advisory committees have voted in opposition. In May, the Nonprescription Drugs Advisory Committee voted against Merck’s request to market Singulair Allergy (montelukast) to adults with allergic rhinitis ( 4). While the committees acknowledged epinephrine’s efficacy, they concluded that its safety was unproven. In February, the joint FDA Pulmonary Allergy Drug Advisory Committee and the Non-Prescription Drugs Advisory Committee voted against Armstrong Pharmaceuticals’ request to market Primatene HFA (epinephrine hydroflouroalkane) to patients with asthma ( 3). In 2014, the FDA evaluated two respiratory medications for potential nonprescription use.
#Over the counter asthma inhaler professional
The American Thoracic Society, a professional medical organization, questioned the paradigm’s benefits and argued that unsupervised use of prescription-only medications might place patients at risk ( 2). Fewer prescription-seeking visits might also lower health care expenditures. The FDA reasoned that reducing the monetary and nonmonetary costs associated with obtaining prescriptions could increase medication access for first-time and continuing users while freeing physicians to care for patients with more complex needs. Food and Drug Administration (FDA) proposed a new paradigm whereby specific, existing prescription-only medications could be made available for nonprescription (“over-the-counter”) use, provided that conditions for their safe use could be established ( 1). This article examines the rationale for, and potential ramifications of, making asthma medications available for nonprescription use. These organizations cited unsubstantiated benefits and unnecessary risks as reasons to oppose greater over-the-counter availability of current prescription-only medications. Many organizations expressed opposition, including the American Thoracic Society and other societies representing patients with respiratory diseases.
The Food and Drug Administration recently requested public comment on a new paradigm whereby specific prescription-only medications could be made available over the counter, provided that conditions for their safe use could be established. The inconvenience and costs associated with obtaining these prescription-only medications are factors that contribute to poor adherence. However, adherence to these medications is suboptimal. Medications that provide quick relief of symptoms and that control airway inflammation are the mainstays of asthma treatment.
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