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FDA Wants to Limit Doses per Package of Diarrhea Drug Imodium Because of Opioid Withdrawal Misuse

FDA Wants to Limit Doses per Package of Diarrhea Drug Imodium Because of Opioid Withdrawal Misuse | Pharma Industry Regulation |

The FDA has asked J&J and makers of generic versions of Imodium to reduce the number of caplets in a retail package. A safety communication released Tuesday by the FDA doesn’t specify the amount the agency wants manufacturers to limit purchases to, but notes that consumers are only supposed to take the over-the-counter version the drug for two days, or a maximum of eight two-milligram pills.


On its website, J&J links to sellers who offered Imodium in packages of 24 to 48 caplets. Other stores had generic versions available online in bottles of as much as 200 pills.


The FDA warned in 2016 that people were using high doses of the active ingredient in Imodium, loperamide, to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria. Taking the drug in large quantities could lead to serious heart problems that could lead to death, according to the agency.


Ten deaths from loperamide use were reported to FDA from its approval in 1976 through Dec. 14, 2015. The agency hasn’t updated those numbers, but it says abuse of the drug is on the rise.


The steps to limit Imodium are part of a broader FDA effort to stem the tide of overdose deaths. More than 42,000 Americans died from opioid overdoses in 2016, according to the Centers for Disease Control and Prevention.

Pharma Guy's insight:

According to the FDA: "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 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."

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