FDA News

FDA: Imodium packaging changes needed to stem abuse, misuse

To limit the misuse and abuse of the over-the-counter anti-diarrheal medication Imodium, the FDA announced that it is working with manufacturers to make a switch to blister and single-use packaging for the product, according to a statement.

Loperamide — sold commercially as Imodium AD (Johnson & Johnson) and as generics — is used in high doses by some individuals with an opioid addiction as an alternative to manage opioid withdrawals or to achieve similar euphoric effects to opioid use.

“With 11.5 million Americans misusing opioids in the past year and more than 40 people dying every day from overdoses involving prescription opioids, it has become abundantly clear that more vigilant action is needed from the FDA and others to get ahead of this crisis,” Scott Gottlieb, MD, commissioner of the FDA said in the statement.

Loperamide works on opioid receptors in the gut to reduce the number of bowel movements over a short period. It is approved for 8 mg a day for OTC use but is often packaged in large volume bottles sold at pharmacies and online.

When taken in high doses, it can lead to severe heart rhythm problem and death, according to the press release. In an accompanying Safety Communication, the FDA laid out the symptoms of a loperamide overdose: fainting, rapid heartbeat or irregular heart rhythm and unresponsiveness.

The FDA requested that retail packages of loperamide only contain a limited amount of the drug for short-term diarrhea. They recommended a package of eight 2-mg capsules in blister packaging.

Because the abuse of loperamide requires the purchase of very large quantities of the drug, Gottlieb said he will also reach out to online retailers and ask them to take voluntary steps to help address the issue.

“Today’s action is intended to change how the product is packaged, to eliminate these large volume containers,” he said in the press release. “I believe anyone who is distributing health care products has an obligation to be a partner in helping address the most pressing public health challenges like opioid abuse.”

Disclosures: Gottlieb is employed by the FDA.

To limit the misuse and abuse of the over-the-counter anti-diarrheal medication Imodium, the FDA announced that it is working with manufacturers to make a switch to blister and single-use packaging for the product, according to a statement.

Loperamide — sold commercially as Imodium AD (Johnson & Johnson) and as generics — is used in high doses by some individuals with an opioid addiction as an alternative to manage opioid withdrawals or to achieve similar euphoric effects to opioid use.

“With 11.5 million Americans misusing opioids in the past year and more than 40 people dying every day from overdoses involving prescription opioids, it has become abundantly clear that more vigilant action is needed from the FDA and others to get ahead of this crisis,” Scott Gottlieb, MD, commissioner of the FDA said in the statement.

Loperamide works on opioid receptors in the gut to reduce the number of bowel movements over a short period. It is approved for 8 mg a day for OTC use but is often packaged in large volume bottles sold at pharmacies and online.

When taken in high doses, it can lead to severe heart rhythm problem and death, according to the press release. In an accompanying Safety Communication, the FDA laid out the symptoms of a loperamide overdose: fainting, rapid heartbeat or irregular heart rhythm and unresponsiveness.

The FDA requested that retail packages of loperamide only contain a limited amount of the drug for short-term diarrhea. They recommended a package of eight 2-mg capsules in blister packaging.

Because the abuse of loperamide requires the purchase of very large quantities of the drug, Gottlieb said he will also reach out to online retailers and ask them to take voluntary steps to help address the issue.

“Today’s action is intended to change how the product is packaged, to eliminate these large volume containers,” he said in the press release. “I believe anyone who is distributing health care products has an obligation to be a partner in helping address the most pressing public health challenges like opioid abuse.”

Disclosures: Gottlieb is employed by the FDA.