Other safety alerts
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| The United States: Imodium (loperamide) for over-the-counter use: Drug Safety Communication - FDA limits packaging to encourage safe use |
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The US Food and Drug Administration (FDA) announces that, 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 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.
FDA is continuing to evaluate this safety issue and will update the public when more information is available.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm594403.htm
In Hong Kong, there are 63 registered pharmaceutical products containing loperamide. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to loperamide. Related news was previously issued by the FDA and UK Medicines and Healthcare products Regulatory Agency (MHRA), and was posted on the Drug Office website on 8 Jun 2016 and 27 Sep 2017 respectively. Letters to inform local healthcare professionals were issued by DH on 8 Jun 2016. Cardiotoxicity of loperamide related to the use of higher than recommended doses, and to its abuse or for self-treatment of opioid withdrawal is documented in reputable drug references such as Martindale: The Complete Drug Reference. DH will remain vigilant on safety update of loperamide issued by other overseas drug regulatory authorities.
Ends/Wednesday, Jan 31, 2018
Issued at HKT 15:00
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