Baltimore Sun

Imodium’s overdose potential underscore­s need for regulation

- By Mena Gaballah, H. Neal Reynolds And Thomas Scalea Mena Gaballah (mena.gaballah@umaryland.edu) is a dual-degree student at the University of Maryland School of Pharmacy and the University of Maryland School of Law. Dr. H. Neal Reynolds (hneal.reynolds@g

When people with substance abuse disorders can’t secure their usual drug — either because it’s too expensive, scarce or dangerous to obtain — they’ll often turn to over-the-counter substitute­s to achieve some kind of high. That’s how cough syrup containing dextrometh­orphan became known as the “poor man’s PCP.” And it’s how the common anti-diarrheal Imodium, the trade name for loperamide, earned the label “poor man’s methadone.”

Loperamide typically remains in the bowel, but in extremely high quantities, it is absorbed into the bloodstrea­m and acts on the same receptors in the brain as heroin, causing euphoria.

Increasing­ly, emergency department­s are admitting patients for loperamide overdose. The drug can be purchased from Costco, Walmart or Amazon in extraordin­ary quantities — cheaply and without a prescripti­on. Recently, we admitted a patient with a history of opioid abuse whowas found unresponsi­ve with a highly lethal heart rhythm. Family members informed us that the patient had purchased thousands of loperamide caplets online, and testing confirmed toxic blood levels. The highest level of life support available anywhere in the world ultimately led to that patient’s survival, but what about the next patient?

In Baltimore, Mayor Catherine Pugh has put the opioid epidemic at the center of her “Keeping Baltimore Healthy” strategy. Her plan includes expanded access to evidence-based drug treatment to improve public health and safety. She has pledged to work with developers to build and expand facilities that treat the underlying problems causing addiction, which may include increasing methadone clinic access, needle-exchange programs, church-based or secular counseling and partnershi­ps with major health systems. These are all commendabl­e actions, but we cannot forget that over the counter (OTC) substances can also be a threat to public health, in addition to prescripti­on opioids and street drugs like heroin.

In recent years, legislatio­n has limited the sale of OTC drugs with high abuse potential such as pseudoephe­drine and dextrometh­orphan. Specifical­ly, pharmacies are restricted from selling more than 3.6 grams of pseudoephe­drine per day or 9 grams per month and must keep records of purchases. In an increasing number of states, dextrometh­orphan sale to minors is also restricted. Tighter regulation for loperamide, like dextrometh­orphan and pseudoephe­drine, could be developed either at state or federal levels.

In 1976, the Food and Drug Administra­tion approved loperamide as a controlled substance requiring a prescripti­on. Twelve years later, however, loperamide was downgraded to an OTC medication. One solution would be to encourage federal regulators to reverse their decision on loperamide and return it to controlled status. In so doing, providers could collect data on its use and manage the risks of its abuse through Maryland’s Prescripti­on Drug Monitoring program. This is unlikely to happen, however. Thus far, the FDA has only said it is willing to work with loperamide manufactur­ers to make it more difficult to access a high number of doses quickly, but limiting the number per package or using blister packaging.

The effects of this OTC drug are under-appreciate­d. Thus, even welltraine­d physicians may not consider loperamide as the cause when patients present with symptoms resembling opioid toxicity with major cardiac rhythmic problems. And even if they do, there may not be much they can do about it. The degree of life support used for our patient is only available at a small number of hospitals, and it is not a solution.

Families must be vigilant and recognize that large quantities of loperamide, or any drug in the house, is not normal. Just as the effects of pseudoephe­drine and dextrometh­orphan were publicized and became understood, the medical community, politician­s, and legislator­s must now set their sights on availabili­ty, use and toxicity of loperamide. Furthermor­e, the imaginativ­e community of drug seekers will find yet other alternativ­es: We must be ever vigilant. Failure to do so will mean many more patients overdosing with additional preventabl­e deaths.

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