FDA to hear public comments on pulling decongestants like Sudafed off shelves

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FDA to hear public comments on pulling decongestants like Sudafed off shelves
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The market for oral decongestants is huge: A study of 100,000 US households showed that about half purchased medications with phenylephrine each year.

The Food and Drug Administration is taking the battle over Sudafed and other decongestants to the streets.recent finding that phenylephrineOn Tuesday of this week, an FDA advisory panel announced — after examining decades of documentation and clinical trial results — that oral phenylephrine is no better than a placebo at reducing nasal congestion.

Nasal sprays containing phenylephrine are unaffected by the ruling and would remain available for over-the-counter purchases. The FDA will soon allow public comments on a proposal to remove popular decongestants like Sudafed from store shelves.“The public would then have the opportunity to comment on the proposed order. If, after considering the comments, FDA continued to conclude phenylephrine is not effective, the agency would issue a final order … and phenylephrine would no longer be considered GRASE,” the FDA announced.

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