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It doesn’t actually work, so let’s just double the dosage:
New and Improved! It’s Placebo DS!
by Randy Drake

T ast winter I reported that phenylephrine (PE), the decongestant that replaced pseudoephedrine (PSE) in most OTC cold remedies, is almost 100% ineffective. Evidence to support that claim continues to pour in.

In mid-October researchers at the University of Florida reported that “the 10 mg [maximum legal] dose doesn’t relieve stuffy noses any better than a dummy pill.” In fact, UF researcher Leslie Hendeles said that the new formulations “aren’t any better than taking nothing.” (UF article; PDF, 62 KB)

In December, medical reviewers at the FDA agreed that “there is limited evidence that [phenylephrine] actually relieves nasal congestion.” They admit that the studies they used to approve the drug in 1976 are “small, poorly designed, and decades old” and that “nearly all of the phenylephrine studies were inadequate.” Nevertheless, the FDA approved the drug, even though only 7 of the 14 studies they reviewed showed a modest improvement in nasal congestion, and the remaining 7 showed no improvement at all! (FDA article; PDF, 80 KB)

Each day, thousands of people take a drug that doesn’t do what it it claims to do. So what solution to this problem did the UF researchers propose? Increase the allowed dosage to 25 mg.

Neither UF researchers nor anyone else has actually done studies to prove the efficacy of phenylephrine at 25 mg. In fact, FDA review documents suggest that there is “mixed evidence” that phenylephrine would work at the increased dosage. So in effect, the “new & improved” dosage proposed by the UF would just give us more than twice as much of a drug that has been proven not to work!

God forbid that drug companies would go back to using the safe and effective nasal decongestants they’d used for decades. God forbid that the medically ignorant elected to public office across this country would reverse the stupid legislation they’d passed. Nope! We should just take more of a drug that doesn’t work.

Instead of giving your hard-earned dollars to drug companies for this bogus remedy, read my previous article for suggestions on choosing products that actually do work.


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