FDA Shifts Aim At Loperamide Packaging In War Against Opioid Abuse


With more than 40 Americans dying each day because of opioid abuse, the U.S. Food and Drug Administration is intensifying its efforts by implementing new limitations on over-the-counter loperamide medication.

Loperamide is an opioid agent commonly used to treat the short-term symptoms of diarrhea. It promotes intestinal slowdown when taken in proper doses but if abused, it induces euphoria by binding brain receptors.

On a molecular level, it has the same effect on the body just like strong illicit drugs such as heroin, morphine, and oxycodone. However, loperamide is more readily available at a significantly cheaper price.

To get high off the medication, addicts have to take extreme measures. According to Dr. Scott Krakower, an addiction specialist at Northwell Health, they pop from around 50 to 300 pills per day.

FDA Commissioner Wants Smaller Blister Packs For Imodium

In its most recent announcement, the FDA stressed that loperamide abuse is increasingly becoming a problem for the country. To address the problem, one of its solutions is to limit intake by requesting manufacturers to use smaller blister packaging.

Current regulations allow a maximum daily dosage of 8 milligrams for adults purchasing OTC and 16 milligrams if prescribed by a physician.

The medication is marketed under store brands and the brand name Imodium A-D. It is also available through its generic name.

In spring of 2017, the FDA imposed the addition of labels that warn consumers of risks that come with ingesting large doses of loperamide, including overdose and death.

On Jan. 31, the agency has once again called the attention of OTC manufacturers. This time, it intends to regulate the medication's packaging to ensure it would only contain enough for the treatment of short-term diarrhea.

"One example is a single retail package containing eight 2-milligram capsules in blister packaging," writes FDA Commissioner Scott Gottlieb. "We asked manufacturers to take the necessary steps to implement these changes in a timely fashion."

The announcement also appeals to online distributors for voluntary action on this matter as the agency can only exercise limited control over such establishments. Gottlieb explained that loperamide abusers often purchase from these retailers as they require the medication in large quantities. Commonly, they order bottles of pills online.

So far, manufacturers have responded cooperatively to the FDA's new regulations. Johnson & Johnson, the company behind Imodium, says that it will remain partners with the agency in educating consumers.

Agency Releases Updated Opioid Analgesic REMS Education Blueprint

Aside from the announcement, the FDA has also released an updated version of its Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.

The Blueprint now contains new information on pain management strategies including pharmacologic and nonpharmacologic treatment. This step is expected to educate professionals regarding the proper use of opioids.

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