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The unanimous vote, which specifically declared oral formulations of phenylephrine ineffective, is expected to disrupt the market for OTC cold and allergy remedies, where consumers largely prefer ...
The U.S. Food and Drug Administration (FDA) announced that it plans to ban products containing phenylephrine, an ingredient found in many over-the-counter (OTC) oral cold and flu medications.
The stakes are high, experts say, because a committee vote declaring phenylephrine ineffective as an oral decongestant could push the FDA to revoke the drug’s over-the-counter designation as ...
On Thursday, the FDA proposed removing oral phenylephrine from the list of approved active ingredients for over-the-counter (OTC) nasal decongestants, citing concerns over its effectiveness. After ...
The Food and Drug Administration (FDA) is proposing the removal from the market of a common ingredient found in most oral over-the-counter cold medicines because it doesn’t work.
Factors that may induce or sustain [2] hyperventilation include: physiological stress, anxiety or panic disorder, high altitude, head injury, stroke, respiratory disorders such as asthma, pneumonia, or hyperventilation syndrome, [5] cardiovascular problems such as pulmonary embolisms, anemia, an incorrectly calibrated medical respirator, [1] [3 ...
The FDA advisory committee’s decision last year was nonbinding — meaning the FDA itself makes the final call on whether oral phenylephrine is considered effective and whether it needs to be ...
The FDA assembled its outside advisers to take another look at phenylephrine, which became the main drug in over-the-counter decongestants when medicines with an older ingredient ...