Imotil FDA Alerts

Voluntary Recall of Certain Family Dollar Over-the-Counter Products

July 21, 2022 -- Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022 due to product being stored outside of labeled temperature requirements.

To date, Family Dollar has not received any consumer complaints or reports of illness related to this recall.

A list of the recalled products is attached. This recall goes to the retail store level.

Family Dollar has notified its affected stores asking them to check their stock immediately and to quarantine and discontinue the sale of any affected product. Customers that may have bought affected product may return such product to the Family Dollar store where they were purchased without receipt. This recall does not apply to Delaware, Alaska, Hawaii as no Family Dollar stores in Delaware received any products subject to this recall and Family Dollar does not have any stores in Alaska or Hawaii.

Customers with questions regarding this recall may contact Family Dollar Customer Service at 844-636-7687 between 9am and 5pm EST. Customers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular 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
• https://www.fda.gov/safety/report-problem-fda

List of Recalled Products

Source: FDA

Drug Safety Communication: Imodium (loperamide) for Over-the-Counter Use - FDA Limits Packaging To Encourage Safe Use

[9-20-2019] UPDATE
To help address loperamide abuse and misuse, FDA approved changes to the packaging for tablet and capsule forms of the brand-name over-the-counter (OTC) anti-diarrheal medicines Imodium A-D, Imodium Multi-Symptom Relief, and Be Health Loperamide HCl Capsules. These changes limit each carton to no more than 48 mg of loperamide and require the tablets and capsules to be packaged in individual doses. FDA continues to work with manufacturers, including those of generic and liquid OTC loperamide products to institute appropriate package sizes and types that support the safe use of these medicines.

This is an update to the FDA Drug Safety Communication: Loperamide (Imodium) - Serious Heart Problems With High Doses From Abuse and Misuse - June 7, 2016

[1-30-2018]
ISSUE: To foster safe use of the over-the counter (OTC) anti-diarrhea drug loperamide, FDA is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package. FDA continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of loperamide, primarily among people who are intentionally misusing or abusing the product, despite the addition of a warning to the medicine label and a previous communication. Loperamide is a safe drug when used as directed.

Loperamide acts on opioid receptors in the gut to slow the movement in the intestines and decrease the number of bowel movements. It is safe at approved doses, but when much higher than recommended doses are taken, it can lead to serious problems, including severe heart rhythm problems and death.

FDA is continuing to evaluate this safety issue and will update the public when more information is available.

BACKGROUND: Loperamide is FDA-approved to help control symptoms of diarrhea, including Travelers’ Diarrhea. The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use. It is sold under the OTC brand name Imodium A-D, as store brands, and as generics.

FDA previously issued a Drug Safety Communication about this safety concern in 2016, and added warnings about serious heart problems to the drug label of prescription loperamide and to the Drug Facts label of OTC loperamide products.

RECOMMENDATION: Patients and consumers should only take the dose of loperamide directed by your health care professionals or according to the OTC Drug Facts label, as taking more than prescribed or listed on the label can cause severe heart rhythm problems or death. If you are using OTC loperamide and your diarrhea lasts more than 2 days, stop taking the medicine and contact your health care professional.

Seek medical attention immediately by calling 911 if you or someone taking loperamide experiences any of the following, and tell health care professionals the person has been taking loperamide:

• Fainting
• Rapid heartbeat or irregular heart rhythm
• Unresponsiveness, meaning that you can’t wake the person up or the person doesn’t answer or react normally

Health care professionals should be aware that using much higher than recommended doses of loperamide, either intentionally or unintentionally, can result in serious cardiac adverse events, including QT interval prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope, and cardiac arrest. In cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects. Some individuals are taking high doses of loperamide to treat symptoms of opioid withdrawal. If loperamide toxicity is suspected, promptly discontinue the drug and start necessary therapy. For some cases of abnormal heart rhythms in which drug treatment is ineffective, electrical pacing or cardioversion may be required. Also counsel patients to take loperamide only as prescribed or according to the OTC Drug Facts label and advise patients that drug interactions with commonly used medicines may increase the risk of serious cardiac events.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form 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

[01/30/2018 - Drug Safety Communication - FDA]

Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse

ISSUE: FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide (see Examples of Drugs that Can Potentially Interact with Loperamide, in the FDA Drug Safety Communication).

The majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria. FDA continues to evaluate this safety issue and will determine if additional FDA actions are needed.

BACKGROUND: Loperamide is approved to help control symptoms of diarrhea, including Travelers’ Diarrhea. The maximum approved daily dose for adults is 8 mg per day for OTC use and 16 mg per day for prescription use. It is sold under the OTC brand name Imodium A-D, as store brands, and as generics. See the FDA Drug Safety Communication for data summary.

RECOMMENDATION: Health care professionals should be aware that use of higher than recommended doses of loperamide can result in serious cardiac adverse events. Consider loperamide as a possible cause of unexplained cardiac events including QT interval prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope, and cardiac arrest. In cases of abuse, individuals often use other drugs together with loperamide in attempts to increase its absorption and penetration across the blood-brain barrier, inhibit loperamide metabolism, and enhance its euphoric effects. If loperamide toxicity is suspected, promptly discontinue the drug and start necessary therapy. If loperamide ingestion is suspected, measure blood levels, which may require specific testing. For some cases of Torsades de Pointes in which drug treatment is ineffective, electrical pacing or cardioversion may be required. Refer patients with opioid use disorders for treatment (see Additional Information for Health Care Professionals in the FDA Drug Safety Communication).

Patients and consumers should only take loperamide in the dose directed by their health care professionals or according to the OTC Drug Facts label. Do not use more than the dose prescribed or listed on the label, as doing so can cause severe heart rhythm problems or death.

If your diarrhea lasts more than 2 days, stop taking loperamide and contact your health care professional. Seek medical attention immediately by calling 911 if you or someone taking loperamide experiences any of the following:

• Fainting
• Rapid heartbeat or irregular heart rhythm
• Unresponsiveness, meaning that you can’t wake the person up or the person doesn’t answer or react normally 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form 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

[06/07/2016 - Drug Safety Communication - FDA]