FDA Warns Against Using OPMS Black Liquid Kratom Following Consumer Death

Kratom side effects have been linked to dozens of deaths, according to the FDA, which warns consumers to throw the dietary supplement away.

Consumers should not use OPMS Black Liquid Kratom because it may cause serious side effects like aggressive behavior, addiction, and even death, according to a new federal health warning.

The U.S. Food and Drug Administration issued the kratom warning on July 26, after receiving an adverse event report involving at least one person who died after using Optimized Plant Mediated Solution Black Liquid Kratom.

Kratom is a plant native to Asia, which has gained popularity in recent years as a dietary supplement due to the perceived benefits for pain relief, anxiety, and energy. As a dietary supplement, the leaves of the plant are dried, crushed, and used in tea or other consumer products. However, side effects of kratom has been linked to a number of recent health concerns.

Kratom Health Concerns

In 2016, the U.S. Justice Department’s Drug Enforcement Administration (DEA) proposed a rule to list Kratom as a Schedule I controlled substance, along with heroin and other highly addictive drugs. The rule was declined by Congress, but the DEA has maintained its stance that kratom is potentially harmful to users.

Then in 2018, the FDA issued a warning for Kratom products, indicating it was not safe for medicinal purposes. The warning was issued after the agency received reports of 44  deaths linked to Kratom use.

Earlier this year, a wrongful death lawsuit was filed by the family of a man who died due to Kratom-associated side effects. The autopsy determined the man had high levels of alkaloids linked to Kratom poisoning.

Black Liquid Kratom Warning

In the new FDA health alert, the agency issued a “Do Not Use” warning for Optimized Plant Mediated Solution (OPMS) Black Liquid Kratom.

The warning indicates the FDA has serious concerns about the safety and use of Kratom in dietary supplements and consumer foods. The available scientific data and information indicate Kratom is known to cause serious side effects and health risks, including liver toxicity, seizures, and substance use disorder (SUD).

Consumers have reported experiencing serious side effects, such as withdrawal symptoms, addiction, digestive issues, restless leg syndrome, skin problems, aggressive behavior, increased anxiety, lack of energy, and inability to focus.

The OPMS label indicates the product contains Kratom alkaloids, mitragynine, and 7-hydroxymitragynine (7-OH mitragynine).

The FDA has not approved any prescription or over-the-counter drug products or supplements containing Kratom or associated compounds, including mitragynine and the more potent metabolite, 7-OH mitragynine.

Consumers may believe Kratom products are safe because Kratom is made from a plant and is available online and in some retail stores, like vape/smoke shops. But, Kratom is not lawfully marketed as a dietary supplement and cannot be lawfully added to conventional foods.

Consumers who have recently purchased OPMS Black Liquid Kratom sold online and in certain retail stores should not use it and discard the product, the FDA advises.

Anyone who has experienced side effects from taking Kratom should report it to the FDA’s MedWatch Adverse Event Reporting program.