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At Health Canada's request, Nutrabolics Inc. is voluntarily recalling "Blackout," a sleep-aid product, because it may pose serious health risks.
Health Canada says that the sleep aid contains the drug L-trytophan at a prescription strength dose.
Blackout has not been authorized by Health Canada, which means it has not been evaluated for safety, effectiveness or quality.
“At prescription doses, this medication should be used only under the supervision of a health care professional because of the higher risk of serious side effects and harmful drug interactions,” says Health Canada.
L-tryptophan is prescribed in Canada for use in combination with antidepressants for patients with depressive disorders.
The health authority warns that in rare cases, serotonin syndrome has been reported when L-tryptophan was taken with other drugs, including some that affect the central nervous system.
Serotonin syndrome is a potentially life-threatening reaction with symptoms that include high body temperature, agitation, sweating, rapid heart rate and high blood pressure, muscle rigidity, confusion and seizures.
Officials say that Blackout may have been sold at multiple retailers, both online and in stores, across Canada.