Drugs

Panel Votes Down OTC Cold Ingredient

FDA’s Nonprescription Drugs Advisory Committee 9/12 voted 16 to 0 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. Phenylephrine is the active ingredient found in a number of common OTC cold and allergy treatments, such as Sudafed PE and Benadryl Allergy Plus Congestion.

University of California San Diego professor Jennifer Le said while voting no that oral phenylephrine is not efficacious for the symptomatic treatment of nasal congestion associated with both the common cold and allergic rhinitis. She recommended that FDA reconsider the drug’s labeling as Generally Recognized as Safe and Effective “since this may lead to consumer confusion about the efficacy of the drug.” She also expressed concern over the drug’s poor efficacy that equates to a safety issue for delaying effective treatment.

Also voting no was National Cancer Institute senior investigator William D. Figg, who said the “financial toxicity” associated with an ineffective drug was overwhelming. Earlier during the meeting, the panel was told that almost $2 billion annually is being spent on OTC remedies containing phenylephrine. “I agree it probably precludes any further studies to increase the dose with such a low bioavailability and a high first-pass metabolism,” he added.

The ball is now in FDA’s court to decide the OTC monograph status of the active ingredient.

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