FDA warns CanaRx for selling unapproved, misbranded and unsafe imported drugs to unsuspecting Americans
The Food and Drug Administration posted a warning letter late yesterday afternoon to CanaRx for facilitating the distribution of unapproved new drugs and misbranded drugs to U.S. consumers. These drugs are potentially dangerous to U.S. consumers.
The drugs distributed by CanaRx may have different dosage strengths or be manufactured by companies different than the FDA-approved drug. They may be from different regions and they may be counterfeit. The substitution of FDA-approved prescription drugs with unapproved versions that may have substantially different risk profiles can pose serious health risks to consumers, especially in vulnerable patient populations that suffer from serious conditions such as HIV, cancer or hepatitis.
“Operations like CanaRx use their names to imply that patients are receiving medicines approved in Canada, when it’s likely that patients are receiving medicines from other countries, and which may be sub-potent, super-potent or counterfeit,” said FDA Commissioner Scott Gottlieb, M.D.”To protect patients from these unapproved drugs, we urge employers and any enrolled employees not to use any medicines from CanaRx. The FDA will pursue additional enforcement actions as needed.”
Unapproved, imported drugs do not have the same assurance of safety, efficacy and quality as drugs subject to FDA oversight and may be sub-potent, super-potent or counterfeit. CanaRx’s substitution for prescribed FDA-approved drugs can have safety consequences for patients because, for example, their condition may not improve and the patient’s health care provider may not know that this may be attributed to an unapproved drug. This can also cause potentially dangerous drug interactions with the patient’s other medications. In addition, sourcing drugs from uninspected, unregulated or unknown supply chains can result in serious health consequences, especially in vulnerable patient populations, who may receive drugs that are adulterated, or are not shipped or stored properly.
CanaRx also offers certain drugs on its medication lists for which the FDA-approved version is subject to a REMS program and is indicated to treat serious conditions such as HIV, cancer or hepatitis. For example, the REMS for Tracleer, a medicine used to treat certain types of pulmonary arterial hypertension, which is high blood pressure in the vessels of the lungs, restricts distribution of the drug to only health care providers who comply with the requirements of the REMS, in order to minimize the risk of fetal exposure and serious birth defects in female patients taking Tracleer and the risk of liver damage in patients. No such safe-guards are in place for the “Tracleer” distributed by CanaRxv.
In some instances, the FDA-approved versions of several drugs listed on CanaRx’s medication lists have been subject to one or more recalls in the U.S. The FDA has established processes to ensure the recall of unsafe, substandard and poor-quality drugs within the legitimate U.S. drug supply chain, but no such official safeguards exist for unapproved drugs illegally distributed in the U.S. from foreign sources. Many of the foreign versions of FDA-approved drugs substituted by CanaRx are likely to have been subject to foreign recalls not adequately carried out in the U.S., presenting unacceptable risks of harm to U.S. consumers.
The warning letter also lists more than 150 websites affiliated with CanaRx, which is not intended to be an all-inclusive list. The warning letter requests that CanaRx respond within 10 working days, with details of how the violations noted in the warning letter will be corrected. Any violations not corrected in the warning letter could lead to enforcement action.
