Sinusitis Indication Removed From OTC Decongestant Monograph

Marketers of OTC nasal decongestants have an April 11, 2007 deadline to remove references to the indication "sinusitis" from product labeling in order to comply with a monograph amendment.

Producers with annual sales less than $25,000 will have until Oct. 11, 2007 to comply.

A final rule published in the Oct. 11 Federal Register amends the final monograph for OTC nasal decongestant products to remove the indication "for the temporary relief of nasal decongestion associated with sinusitis."

The terms "sinusitis" and "associated with sinusitis" will be prohibited anywhere on product labeling.

The amendment was published as a proposed rule in August 2004 (¹ (Also see "FDA Proposes “Sinusitis” Exclusion From OTC Nasal Decongestant Monograph" - Pink Sheet, 2 Aug, 2004.), p. 6).

Data on decongestants for sinusitis treatment are "limited and controversial" the agency says, citing a dearth of prospective studies.

Topical nasal decongestants in particular "may have a negative effect on the resolution of sinusitis, as they may increase the degree of sinus inflammation."

The agency also expresses concern that consumers will treat their symptoms with decongestants and forgo seeking medical treatment for the underlying condition.

"Consumers may interpret current product labeling as implying that a nasal decongestant can treat sinusitis and will delay consulting a physician for treatment," the final rule says.

"The delay in medical evaluation could also result in a lost opportunity for early diagnosis of another serious medical condition in consumers who have symptoms similar to sinusitis."

FDA cites bacterial sinusitis and sinusitis accompanied by asthma as conditions for which delay of treatment could lead to more serious complications.

The agency originally included the sinusitis indication in a 1976 advance notice of proposed rulemaking on the recommendation of the OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic Drug Products advisory review panel.

However, the agency now "no longer considers sinusitis an appropriate OTC indication and believes that the current labeling is potentially misleading."

The final rule cites treatment guidelines published in the December 1998 Journal of Allergy and Clinical Immunology and others released by the American Academy of Pediatrics in 2001.

The agency rejected a number of arguments submitted by Pfizer in December 2004 comments on the proposed rule (² (Also see "Sinusitis Exclusion From Nasal Decongestant Labels Is Unsupported – Pfizer" - Pink Sheet, 6 Dec, 2004.), p. 6).

For example, Pfizer's claim that current labeling is adequate to prevent consumers from delaying treatment was not accompanied by data, FDA says.

Current labeling directs consumers to see a doctor if symptoms do not improve within seven days or are accompanied by fever.

However, the occurrence of fever in patients with sinusitis is "variable," FDA notes, and concomitant analgesic use may mask such symptoms.

Furthermore, Pfizer's contention that consumers are unlikely to mistake treatment claims for disease treatment claims was similarly unaccompanied by data, the final rule states.

Pfizer's Sudafed pseudoephedrine and phenylephrine formulations will be affected by the rule, as will certain sinus products under Wyeth's Advil line, Tylenol Sinus Severe Congestion from McNeil and private label products. Schering Plough's topical spray Afrin also carries sinusitis references.

FDA estimates a one-time compliance cost to industry for relabeling of $3,000 to $4,000 per SKU, based on information from manufacturers.

Of the roughly 2,000 decongestant SKUs on the market, the agency estimates about 26%, or 520 SKUs, currently carry a sinusitis claim, for a total industry cost ranging between $1.6 mil. and $2.1 mil.

The compliance period should allow firms to use up existing stock and make the changes "in the normal course of business," FDA says.

- Christopher Walker