Drugs

FDA Clarifies Safety of Phenylephrine Products

FDA has issued a safety clarification about its 9/12 Non-prescription Drug Advisory Committee deliberation and 16 to 0 vote (see story) that current scientific data do not support the effectiveness of the over-the-counter monograph dosage of orally administered phenylephrine (10mg) as a nasal decongestant. In the notice, the agency noted that “neither FDA nor the committee raised concerns about safety issues with use of oral phenylephrine at the recommended dose.”

The clarification outlines how FDA would proceed if it determines that oral phenylephrine is not effective. The agency would “first issue a proposed order removing phenylephrine from this monograph,” it says. “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 removing this ingredient from the monograph, and phenylephrine would no longer be considered GRASE. FDA would then work closely with manufacturers to reformulate products as needed to help ensure availability of safe and effective products to treat symptoms of colds or allergies.”

Additionally, FDA notes that phenylephrine is also an ingredient in nasal sprays to treat congestion, and that the advisory committee only reviewed orally administered phenylephrine. “Phenylephrine-containing nasal sprays will not be affected by any possible actions taken for phenylephrine in orally administered products (such as tablets or capsules that contain phenylephrine).”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome