Drugs

FDA Seeks Patient Input on Loperamide Restrictions

FDA commissioner Scott Gottlieb says the agency is seeking input from the patient community on how best to strike a balance between restricting loperamide availability to deter its abuse to produce an opioid high and the legitimate need for the drug for patients suffering from chronic diarrhea associated with inflammatory bowel disease, including Crohn’s disease. Loperamide is sold in branded and generic prescription forms and over-the-counter as Immodium A-D.

Writing in an FDA Voice blog post, Gottlieb says FDA doesn’t want to create access issues for patients with chronic diarrhea, and is proceeding in a step-wise, deliberative fashion “to ensure that the actions we take in relation to OTC loperamide use are reasonable and scientifically sound, and that these actions are necessary to achieve safe use of the drug and to address the issue of abuse and misuse.”

One of the steps FDA has announced is to ask manufacturers to change packaging of the OTC product, such as using blister packs, to help deter abuse. “OTC loperamide is currently approved in packages of eight to 200 tablets, which are often sold in multipacks of more than 1,000 tablets at a time,” Gottlieb says. “This is more than a three-year supply if the drug is taken according to the product label. Evidence suggests that reasonable packaging limitations and unit-of-dose packaging may reduce medication overdose and death.”

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