Consult Your Pharmacist - BP Effects of Nasal Decongestants

US Pharmacist. 2000;25(2) 

In This Article

Safety of Topical Decongestants

In the FDA's final rule, the agency summarized some communications it had received regarding topical nasal decongestants. Each expressed the opinion that sprays and drops should not be required to carry the warning cited above. One reasoned that systemic distribution of topical decongestant sprays and drops should be so minimal as to have no effect. Another opined that patients would be unable to accidentally swallow enough topical product to cause a reaction. The FDA examined the studies submitted by the correspondents but failed to find support for the assertion that topical products would be safe for patients with high blood pressure or heart disease. Further, the agency found that cardiovascular adverse reactions are among the most frequent adverse effects noted with topical nasal decongestants, exceeded only by rebound congestion. They discovered that all sprays and drops (especially oxymetazoline) produced bradycardia, tachycardia, hypertension and hypotension. Thus, the warnings are required on decongestant drops and sprays.

Somewhat later, the FDA amended the nasal decongestant monograph to discuss desoxyephedrine, which assumed the new name levmetamfetamine.[2] The warning against use in high blood pressure is not required for this inhaler ingredient. The warning is also not required for propylhexedrine, the other inhaler ingredient.


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