Talking with Theresa M. Michele, M.D., who is the director of the Division of Nonprescription Drug Products, CDER.
Recently, FDA began taking steps to implement packaging limitations for the common anti-diarrhea medicine loperamide, which is sold over-the-counter (OTC) under the brand name Imodium, under store brands, and in generic form. The agency is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. This move is part of a collaborative effort with manufacturers to foster safe use of the medicine, and to reduce the likelihood of its misuse or abuse. In the last few years, the FDA has seen an increase in reports of unsafe use of the medicine, which can result in severe heart problems.
Theresa Michele discusses why the FDA is taking this action and what health care providers can do if they suspect a patient may be misusing or abusing the medicine.
To learn more, please visit: Reducing the Risk of Loperamide Misuse and Abuse.