Drugs

Don’t Move Imodium from OTC to Rx: CHPA

The Consumer Healthcare Products Association (CHPA) says FDA should deny a citizen petition filed by a Sajoy Varghese of the Jesse Brown VA Medical Center, Chicago, seeking an amendment of the marketing status of Imodium (loperamide) from nonprescription (over-the-counter) to prescription. “Based on the available evidence demonstrating a long history of safe and effective use of loperamide when used according to labeled directions as well as a low rate of abuse/misuse of loperamide, we do not believe that changing the marketing status of loperamide from OTC to prescription is warranted,” a CHPA petition response says. “While published literature reports of serious cardiac adverse events and deaths in association with massive overdose of loperamide have increased in recent years, the number of such events is still extremely low.”

The association says it is working with its member companies and FDA to further assess reports of loperamide misuse/abuse and to develop additional strategies to mitigate such occurrences. Its letter notes a 6/2016 FDA drug safety communication addressing serious heart problems reported in association with loperamide taken in doses higher than recommended, often to avoid opiate withdrawal or as an opiate substitute. “The majority of these cases involved individuals who were intentionally misusing/abusing high doses of loperamide,” it says. CHPA says that issues raised by the agency in its safety communication were addressed in an 8/2016 product labeling update when FDA issued a supplement request to update labeling for loperamide NDA products. The changes included addition of a Heart Alert warning and revised pediatric dosing instructions, it says.

The association says it and its member companies are considering a broad range of actions intended to develop a better understanding of the misuse and/or abuse of loperamide, including monitoring and assessing cases of loperamide abuse reported in social media or reported to databases. “Such efforts may contribute to the understanding of trends and aid the development of effective interventions,” the letter says. “We are also discussing ways to effectively communicate with a broad range of stakeholders in this effort as a means of enhancing understanding and awareness of this issue. Through cooperative efforts such as these, and ongoing monitoring, CHPA believes that loperamide can safely remain an over-the-counter product.”

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