The Food and Drug Administration (FDA) has issued a warning letter to CanaRx, a company operating as a prescription drug provider, for its involvement in the distribution of certain unapproved or misbranded drugs that may be harmful to US consumers.

The letter includes the agency’s concerns with the “scheme CanaRx uses to contract with public and private entities to provide prescription drug coverage to their employees.” The Company is believed to have had foreign prescribers rewrite US prescriptions and then supply employees with unapproved versions of FDA-approved drugs purportedly sourced from countries like Canada, the UK, or Australia, as these countries have stringent drug review processes. However, the agency states, this was “not necessarily always the case.”

Consequently, the employees are led to believe that they will receive safe and effective medicines through their insurance plan “and may not question their legitimacy.” The letter also includes over 150 websites affiliated with CanaRx.

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Compared with FDA-approved drugs, those distributed by CanaRx may have different strengths or be manufactured by different companies/regions; some of these products may have also been previously recalled in the US. Substitution with counterfeit medications may pose serious health risks to consumers. For example, taking unapproved, imported drugs that are subpotent in nature can lead to health consequences particularly in vulnerable populations (i.e., cancer, HIV patients), while taking those that are superpotent may result in potentially dangerous drug interactions.

Some of the medications on CanaRx’s list include those for which the FDA-approved version has a REMS (Risk Evaluation Mitigation Strategy) requirement. “These risk mitigation programs are a legal requirement and are in place for important safety reasons,” said FDA Commissioner Scott Gottlieb, MD. “Sidestepping them is unacceptable and puts the safety of patients in great jeopardy.”

At this time, the FDA urges employers and any enrolled employees to not use medications provided to them by CanaRx and to discuss treatment options with their healthcare providers. For more information visit FDA.gov.