FDA CHANGES MONOGRAPH FOR OTC NASAL DECONGESTANT PRODUCTS

The FDA is amending the final monograph (FM) for OTC nasal decongestant drugs to remove language indicating the products can be used to treat sinusitis, according to a recently released final rule.

The final rule, released as part of the FDA's ongoing review of OTC drug products, removes the indication "for the temporary relief of nasal congestion associated with sinusitis" from the FM, and prohibits the use of the terms "sinusitis" and "associated with sinusitis" elsewhere on the labeling for nasal decongestant drugs. The agency said the indication is potentially misleading because recent research suggests OTC nasal decongestants are not effective treatments for sinusitis, a condition in which the sinuses become inflamed.

OTC nasal decongestants are routinely prescribed by physicians to treat sinusitis, but the FDA said current research calls the practice into question. "Recent publications indicate that prospective studies on the role of nasal decongestants in the treatment of sinusitis are lacking, and the data on their uses as an adjunct in the treatment of sinusitis are limited and controversial," the final rule states. "In addition, there is preclinical evidence that topical nasal decongestants may have a negative effect on the resolution of sinusitis."

In light of the questions raised by recent research, the FDA said it is concerned that the current labeling for nasal decongestants may prompt consumers to treat sinusitis symptoms with OTC medications, rather than seek medical evaluation and definitive treatment.

To view the final rule, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0289-nfr0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0289-nfr0001.pdf)