FDA Reevaluates Over-the-Counter Cold Medications
Phenylephrine, a key ingredient in many over-the-counter cold preparations, has been re-evaluated by the FDA Advisory panel who deemed the ingredient ineffective. Data showed very small amounts of the drug actually reaches nasal mucosa to help decrease congestion. This is due to first pass metabolism that inactivates 99% of the parent drug.
Recommended course: Cough, Cold and Fever Symptoms: Pharmacologic Therapies
This medication became increasingly more utilized among people who were not able to use or could not tolerate pseudoephedrine. According to reports, pseudoephedrine caused a number of untoward effects such as heart palpitations, arrhythmias, tachycardia, urinary retention and elevations in blood pressure.
Phenylephrine has been shown to be less effective than a nasal decongestant which can provide temporary relief of nasal mucosal congestion. However, topical decongestants including oxymetazoline (Afrin) can cause rebound if used for more than the prescribed three days.
While phenylephrine is considered to be a safe medication, its effectiveness is not nearly as good as initially thought. The medication will now go into FDA review to decide if it will continue with the OTC designation.