Thursday, January 30, 2014

Shortage of important heart medication causing concern

MONTREAL - Hundreds of Montreal heart patients are close to running out of a vital medication — and risk ending up in the emergency room — because of an unexpected shortage by the sole Canadian drug manufacturer that produces it.

The pill, a generic medication that is sold under the name of Flecainide, is used to prevent and treat cardiac arrhythmia, including attacks of atrial fibrillation, otherwise known as irregular heartbeat.

Although a Health Canada official said the drug should become available again by mid-February, some patients have already run out of the medication. The sudden scarcity of Flecainide is the latest in a series of drug shortages over the last few years, including antibiotics and chemotherapy agents, despite promises by the pharmaceutical industry to fix the problem.

“I have patients with absolutely no Flecainide left, and many, many others are going to run out within 10 to 15 days, with no medication to keep their hearts at a normal rhythm,” said Sami Magdi, a cardiologist at the Royal Victoria Hospital.

He estimated that hundreds of patients in Montreal, and possibly across the country, are affected by the shortage.

“This particular drug does not have an exact substitute and is not produced by another drug company in Canada,” Magdi added.
“If patients don’t get the medication, they can get an attack of atrial fibrillation and find themselves in the emergency (room). They’re not going to die, but they may have important sumptoms of an irregular heartbeat and some may pass out. They will probably flood the emergency rooms and doctors’ offices.”

Magdi has already contacted Health Canada and the Toronto drugmaker, AA Pharma Inc.

In an email to Magdi, Kelly Lehman, a program manager in the risk management unit of Health Canada, assured him that AA Pharma is working to resolve the shortage.

“I followed up with the company and was advised that the product is in backorder with an estimated re-supply date of mid-February,” Lehman said in the email. “I have asked the company to post the shortage on for better transparency and sharing of information.”

Norman Paul, president of AA Pharma, told The Gazette that his company has maintained a “sterling record” of keeping drugs in stock, “but unfortunately that doesn’t always happen ... and we apologize for the dilemma.

“It’s not like baking brownies,” he said of the “complex business of manufacturing drugs and all of the regulatory (rules) and testing before you release a product on an ongoing basis.”

Paul blamed the lack of Flecainide on a “worldwide shortage of API” or approved pharmaceutical ingredients, noting that a burgeoning pharmaceutical industry in India and other developing nations is using more and more of such raw ingredients for the manufacture of their drugs

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