FDA Issues Warning About Loperamide

The U.S. Food and Drug Administration (FDA) has published several warnings concerning adverse drug events and loperamide use.  You probably recognize loperamide as the primary ingredient in popular anti-diarrhea medication Imodium.  Sold at most drugstores and retailers, loperamide is sold under a variety of generic, store, and brand names.  According to the FDA, using too much loperamide, abusing the drug, or taking it alongside certain other medications can cause serious adverse drug events, including heart problems.

In this article, the medical malpractice attorneys at MedMalFirm.com explain the dangers of this drug, and offer guidance for patients who may have experienced adverse side effects from the medication.

Background and Information

Loperamide is a common over-the-counter (OTC) and prescription anti-diarrhea medication.  Loperamide is recommended for adults experiencing diarrhea and associated symptoms, and may be recommended at an OTC dosage (8-miligrams), or a prescription dosage (16-miligrams) per day.  In general, products containing loperamide should only be given to children under 12 under strict doctor supervision.  The FDA recommends not giving children under two years old products containing the drug.

Loperamide products help reduce intestinal movement by acting along opioid receptors in the brain.  This helps to decrease the frequency and severity of diarrhea and associated symptoms.  While taking loperamide products, it is generally recommended to contact a healthcare provider if diarrhea lasts more than two (2) days, or if your condition worsens.  Loperamide is not designed to be taken long-term, and should not be taken in excess of the recommended dosage.  Always consult your healthcare provider before starting a new medication, especially if you are prone to drug sensitivity, already take other medications regularly, or are unsure of the proper dose you should take.

Loperamide Side Effects

Like most medications, products containing loperamide may result in some general side effects, such as:

• Dizziness
• Dry mouth
• Drowsiness
• Nausea
• Stomach discomfort
• Constipation

These side effects are the most common, and result from using the drug as directed or prescribed.  The recent FDA warning describes the potential dangerous side effects that may occur with overuse, abuse, or adverse drug interaction.  According to the FDA Safety Announcement, serious side effects may include abnormal heart rhythms, cardiac arrest, other serious cardiac events, and even death.

Most of the reports of serious heart problems associated with loperamide are among adults using the drug inappropriately – particularly those attempting to self-medicate opioid withdrawal, or those trying to use the drug to get a “high”.  Consumed in high concentrations, loperamide reportedly can cause a euphoric feeling, making it dangerous for individuals who use drugs for recreational purposes.  With ready availability and no prescription requirement for OTC brands, the potential for misuse and deadly side effects make loperamide a serious concern.

Drug Interactions

Another area of concern for the FDA are reports resulting from loperamide interacting with other medications.  The FDA is currently investigating reports to further their published warning and give consumers additional information about possible risks.  So far, the FDA lists the following medications that may negatively interact with loperamide:

• Cimetidine (Tagamet HB)
• Ranitidine (Zantac)
• Quinine (Qualaquin)
• Clarithromycin (Prevpac, Biaxin)
• Erythromycin (Eryc, Eryped, Ery-Tab)
• Ketoconazole
• Gemfibrozil (Lopid)
• Ritonavir (Norvir, Kaletra, Viekira Pak)

The FDA insists that this list is not exhaustive, and that the exact risks and side effects of drug interactions are unknown.  If you take any medications, OTC or prescription, make sure you check with your healthcare provider prior to taking loperamide products.  Some of these (and likely other) medications may interfere with your body’s ability to properly absorb and distribute loperamide properly.

What You Need to Know

Loperamide is an opioid drug, and therefore has the potential risk for misuse and abuse.  Loperamide should not be used to relieve symptoms of withdrawal, as it is not intended for that purpose, and is largely ineffective.  Individuals with opioid use disorders should get help with their symptoms via an FDA-approved treatment plan.

If you or someone you love uses products containing loperamide, you should contact a healthcare provider or 911 immediately if any of the following symptoms occur:

• Rapid or abnormal heartbeat or rhythm
• Fainting
• Unresponsiveness – Meaning that the person using the drug does not react, respond, or wake up normally

If you get medical attention, it may be necessary for your doctor to specifically order a loperamide blood screen.  Even though it is an opioid, loperamide often does not yield a positive result on standard tests.  This means that even if you have taken too much of the medication and suffered an adverse drug event, your doctor may not be able to attribute your symptoms to the drug.

If you have experienced adverse drug events after taking products containing loperamide, it is also important that you report your experience to MedWatch, the FDA’s adverse event reporting program.  Documenting any medication errors, interactions, side effects, or negative experiences is important in understanding the potential risks of medications Americans take every day.

Getting Help After Adverse Drug Events

Just because the FDA publishes a warning about possible side effects does not mean that retailers and healthcare providers will cease providing the drug to patients and consumers.  As a consumer, you have the right to know about potential risks and side effects of products you buy or are prescribed.  It is the manufacturer’s responsibility to inform healthcare providers and consumers about adverse drug events, and issue a recall if necessary.

As a patient, you also have the right to be informed about medications that are recommended or prescribed to you. Your doctor has the responsibility of gathering information about your health, current medications, possible risk factors, and side effects, and then advising you about your health.  Your doctor serves as something of a mediator between drug manufacturers and you – the patient – and should always carefully consider any warnings or safety alerts before recommending a medication.  Similarly, your pharmacist should only advise you to take medications in accordance with your doctor’s orders, as well as legal and medical guidelines.

Contact Us to Learn More

If you believe that you have been harmed due to medication errors or adverse drug events related to loperamide, contact our medical malpractice attorneys to learn more about the responsibilities of drug manufacturers, doctors, and pharmacists. At MedMalFirm.com, we can help you understand your legal rights and find the best options to ensure that you are compensated for losses associated with healthcare negligence. Fill out our online form to request a free consultation.