Drugs

Senators Seek FDA Imodium Packaging Info

The Senate Homeland Security and Governmental Affairs Committee is asking FDA for information on its 1/30 policy to ask manufacturers to limit packaging for Imodium (loperamide). The agency said it would ask manufacturers to use blister packs or other single-dose packaging to limit the number of Imodium doses available over the counter in one package.

A 4/18 letter to FDA commissioner Scott Gottlieb from committee chairman Ron Johnson (R-WI) and Ranking Member Claire McCaskill (D-MO) says FDA’s rationale for the policy is to address potential safety concerns stemming from individuals mixing loperamide with other drugs to enhance euphoric effects or using loperamide to treat opioid withdrawal.

“While these efforts are well-intentioned,” the senators wrote, “FDA’s policy would limit over-the-counter packs to eight pills, which is enough to treat acute diarrhea for only two days. This decision could have unintended consequences for the millions of Americans who use loperamide on a regular basis, including individuals suffering from Crohn’s and IBS (irritable bowel syndrome).”

The committee asked FDA for information:

describing the process, justification, and analysis underlying FDA’s decision to request limits on packaging for loperamide;
providing the number of deaths that have resulted exclusively from overuse of loperamide between 2013 and 2017, the number of opioid deaths to which the use of loperamide contributed in the same period, and any available estimates of the number of Americans using the drug to manage opioid withdrawal;
describing whether FDA sought or received comments from people who rely on loperamide, including individuals affected by Crohn’s and IBS, with an explanation of how the comments were weighed against other public health considerations; and
describing any applications pending before the agency for additional therapies or treatments for individuals suffering from Crohn’s or IBS.

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