OTC Phenypropylamine---increased stroke risk

A friend of mine forwarded me a brief letter which I feel deserves the widest possible circulation.



There were originally two over-the-counter (vascular) decongestants that were sold for relief of the symptoms of the common cold: phenylpropylamine, and pseudoephedrine. Of the two, phenylpropylamine was observed to cause a more severe vascular constriction in the cerebral circulation, and a statistically significant increase in the incidence of strokes in patients NOT OTHERWISE AT CVA RISK was noted. This was of especial significance in women and children, and so gradually fewer and fewer OTC "cold pills" contained phenylpropylamine. For instance, the popular decongestant Sudafed contained only pseudoephedrine.



Several years ago, the government noted that bathtub chemists were "cooking" psudoephedrine (with acetone, I think) to make methamphetamine, aka "speed" or "crank". The government therefore strongly discouraged the use of OTC pseudoephedrine, and now in some states it is kept behind the drug store's counter, or you have to sign for it, or the amount you can buy is limited.



However, post-marketing studies, as reported in the FDA's surveillance bulletin, have again noticed an increase in strokes associated with the use of phenylpropylamine. Therefore I have send a letter to all of my patients: DISCARD ALL COLD TABLETS CONTAINING PHENYLPROPYLAMINE, and never buy such tablets, either OTC or by prescription. This warning also applies to nasal sprays.



I would hope all my readers follow this advice (and please check with your doctors to notify them of your action and your reason for it).

The FDA link is: http://www.fda.gov/cder/druginfopage/ppa