New Packaging Limits to Promote Safe Use of Loperamide
January 30, 2018 – The U.S. FDA has announced that it is working with manufacturers of loperamide, commonly known as Imodium® and used to control symptoms of diarrhea, to make changes to packaging of the over-the-counter (OTC) medication. Although the drug is safe at approved doses, when taken in much higher amounts it can cause serious heart problems or even be fatal. In some cases, individuals may deliberately abuse loperamide in an attempt to achieve a euphoric effect. In others, loperamide may be misused by individuals seeking to self-treat symptoms of opioid withdrawal.
Sold in several generic forms and store brands as well as under the Imodium® brand name, loperamide slows movement in the intestines by acting on opioid receptors in the gut. Although a warning was added to the drug labeling in 2016 regarding the dangers of misusing or abusing the drug, reports of severe adverse effects from inappropriate use of loperamide continue to be submitted to the FDA.
Manufacturers and the FDA are exploring the use of blister packs and other single-dose packaging, as well as limiting the number of doses in a package, to help encourage safe and appropriate utilization of loperamide. The maximum approved OTC dosage is 8mg per day for adults. With a prescription, adults can take up to 12mg of loperamide per day. Patients should consult a healthcare professional if they have been taking loperamide over the counter for more than two days and their symptoms have not resolved.
In the event an individual experiences fainting, rapid or irregular heartbeat, or unresponsiveness while taking loperamide, call 911 and inform healthcare professionals that the individual has been taking loperamide. The FDA advises healthcare professionals to be aware of the dangers of misusing or abusing loperamide, and to educate patients on safe and appropriate utilization. Adverse events and side effects should be reported to the FDA’s MedWatch program.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.