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Responding to Opioid Crisis, FDA Puts More Restrictions on Imodium

Responding to Opioid Crisis, FDA Puts More Restrictions on Imodium

TUESDAY, Jan. 30, 2018 (HealthDay News) — Increasingly, people addicted to opioid painkillers are using dangerously high doses of the diarrhea drug Imodium (loperamide), either to get high or to help ease withdrawal.

So, on Tuesday the U.S. Food and Drug Administration said it’s putting new restrictions on the packaging of the medication, dubbed by some as “the poor man’s methadone.”

“When higher than recommended doses are taken we’ve received reports of serious heart problems and deaths with loperamide, particularly among people who are intentionally misusing or abusing high doses,” FDA commissioner Dr. Scott Gottlieb said in an agency news release.

Because opioid abusers are using the drug in greater numbers, the FDA is requesting that makers “change the way they label and package these drugs, to stem abuse and misuse,” Gottlieb said.

The FDA already slapped a warning on OTC loperamide labeling in the spring of 2017, cautioning users about the dangers of misuse.

The latest changes relate to the drugs’ packaging.

Specifically, packaging of Imodium should now only “contain a limited amount of loperamide appropriate for use for short-term [‘Traveler‘s’] diarrhea according to the product label,” Gottlieb said.

For example, that might mean a package would only contain eight 2-milligram capsules of the diarrhea drug in a blister pack, the FDA said.

The new rules will also seek to eliminate the sale of loperamide in large bottles — sales that typically occur via the Internet, Gottlieb said.

“The abuse of loperamide requires the purchase of extremely large quantities,” he noted, and “today’s action is intended to change how the product is packaged, to eliminate these large volume containers. We know that many of the bulk purchases of these large volumes are being made online through major online web retailers.”

One busy emergency room doctor said he’s witnessed the problem firsthand, and “applauds” the FDA’s latest move.

“I most often encounter patients who abuse loperamide either to get high or to self-treat symptoms of opioid withdrawal,” said Dr. Robert Glatter, of Lenox Hill Hospital in New York City. “Many people view it as low risk since they think it’s only medicine to treat diarrhea.”

“But those who abuse it to get high are gambling with their life, in essence,” he said. “Simply put, escalating use may place you at risk for an overdose. An overdose of loperamide can make you stop breathing, drop your blood pressure, or even cause a fatal heart arrhythmia.”

But Glatter said even more can be done to curb this new danger.

“It also starts with education, and informing parents and teens via social media platforms of the dangers of loperamide abuse,” he said.

— E.J. Mundell

Published by connie dello buono

Connie Dello Buono is based in Sunnyvale California. Her first ebook is about women's health, Birthing Ways Healing Ways and her recent one is about cancer prevention, Curated Healing Ways. She had helped women have holistic childbirth as childbirth educator, founded Motherhealth, to serve seniors in the bay area with holistic caregivers and blogs at www.clubalthea.com with more than 10,000 health and finance related posts. Connie trains her own caregivers, which are the favorites of most bay area seniors who are home bound and alone. She is active in the rehab and nursing facilities, volunteering on music and movement for seniors. She is a member of Lion's club and offered scholarships to students in the Philippines. She is active at churchinsunnyvale.us and has Fridays Bible home study in Sunnyvale using the recovery version of the Bible , free at biblesforamerica.us She loves dancing and teaching and her courses can be found at https://teachclub.com/@thriveafter60 She is California Life Insurance licensed providing life insurance for older adults with health issues and helping women retire safely with income for life. at menloassetca.com , she helps with 401k rollover. 3 Benefit plans - Mortgage protection using term life insurance to pay for mortgage balance in event of death - Final Expense plan using Single Issue Whole Life Insurance, with cash back, disability benefit and guaranteed in the presence of health issues - Fixed Index Annuity retirement plan for safe, accessibility, less fees, less taxes, avoids probate as it goes directly to beneficiaries, rate of return with no downside market participation. She brings compassion and understanding to the needs of her clients, bringing holistic approach in health and life insurance. Her goal is to free families from worries especially during covid with caregivers and life insurance in the presence of health issues, especially for women. She can be reached at 408-854-1883 , motherhealth@gmail.com

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