Prescription pills in plastic medicine bottles. (© Can Stock Photo / piedmont_photo)Prescription pills in plastic medicine bottles. (© Can Stock Photo / piedmont_photo)
Windsor

Warning issued about unsafe drugs from Windsor pharma company

The U.S. Food and Drug Administration (FDA) is warning Americans about unsafe drugs from a Windsor pharmaceutical company.

The FDA said CanaRX at 235 Eugenie Street West in Windsor is selling unapproved, misbranded and unsafe imported drugs to unsuspecting Americans. Outgoing FDA Commissioner Scott Gottlieb, MD said CanaRx claims its drugs are safe and effective medicines but its violations endanger consumers. He added the scheme is troublesome because employees and consumers will likely trust that they'll receive safe and effective drugs through their employer’s “insurance” plan and may not question their legitimacy.

“The FDA’s regulation and oversight of the drug approval process and distribution protects consumers by requiring rigorous scientific standards, labeling review for accuracy and completeness, and helping to ensure that counterfeit and unsafe drugs do not penetrate the U.S. drug supply, among other things," said Gottlieb. "When companies sidestep important drug safety measures and put patient health at risk by providing unapproved drugs that have been substituted for FDA-approved prescription drugs, it’s the agency’s responsibility to step in to protect the patients.”

He said while operations or illegal online pharmacies may state on their websites that its medicines are coming from Canada, the United Kingdom, Australia, etc., this is not necessarily always the case.

“If an American consumer goes to Canada and walks into a brick-and-mortar Canadian pharmacy and buys a medicine, they’re getting a high-quality drug because of Canada’s first-class drug regulatory process," he added. "When a consumer goes online to buy medicines purportedly from Canada, they may get a medicine sourced from elsewhere that could be counterfeit, expired or misbranded."

The FDA urged employers and any enrolled employees not to use any medicines from CanaRx and added it "will pursue additional enforcement actions as needed.”

Gottlieb said the February 28 warning letter is the result of a lengthy review of the company’s violative practices. The letter states CanaRx facilitates foreign physicians rewriting the employee’s U.S. prescription, and then supplies the employee with unapproved versions of FDA-approved drugs allegedly sourced from Canada, the United Kingdom or Australia and reviewed by those countries.

"Substitution for prescribed FDA-approved drugs can have safety consequences for patients because their condition may not improve and the patient’s health care provider may not know that this may be attributed to an unapproved drug," the FDA said. "This can also cause potentially dangerous drug interactions with the patient’s other medications."

In some instances, the FDA said its approved versions of several drugs listed on CanaRx’s medication lists have been subject to one or more recalls in the U.S.

CanaRx responded to the FDA March 1. A letter from the company said the FDA warning letter has a number of serious inaccuracies and misstatements.

CanaRx said it is not an internet pharmacy but rather has been helping patients get safe and affordable medications from licenced and regulated pharmacies for more than 20 years.

"During these 20 years, the CanaRx safety record is second-to-none and a matter of public record," the Windsor company added.

CanaRx said it tracks each patient and their medication and contacts them when there is a recall.

CanaRx CEO G. Anthony Howard said there is a lot of pressure by the international pharmaceutical industry to preserve its profit margins in the U.S., which are the highest in the world. He added CanaRx's safety protocols are rigorous and the warning is an attempt to curtail personal importation of medications.

Read More Local Stories