Canada asks Ranbaxy to withdraw painkiller

The Canadian health and drug regulator Health Canada has asked Ranbaxy Pharmaceuticals Canada (RPCI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL) to withdraw its generic, 25 microgram per hour strength, fentanyl pain-relief patches from the Canadian market due to safety concerns.

Ranbaxy controls more than 50 per cent of the generic fentanyl market in Canada and this is among the four major revenue earners for Ranbaxy in that country.

Its Canadian operations generated revenues of $29 million in 2007. When contacted, a Ranbaxy spokesperson denied having any information on the Canadian developments.

"Exposure to fentanyl gel that has leaked from the patch may lead to increased skin absorption and could result in serious, potentially life-threatening events, including slowed breathing and possible overdose," Health Canada warned the Canadian citizens. The regulator also asked consumers to return the drug to the pharmacies.

Apart from Ranbaxy, which sells the product only in the Canadian market as Ran Fentanyl transdermal system patches, the regulator has also asked the Toronto based Janssen-Ortho Inc (JOI), part of Johnson & Johnson, to withdraw its branded version 'Duragesic'. 

Ranbaxy sells four generic versions of Fentanyl 25, 50, 75 and 100 microgram per hour strengths in Canada since October 2006, with a licensing and supply agreement with Janssen-Ortho. The product comes under the controlled substance category or narcotic.

Health Canada said the products would be voluntarily recalled by companies because they might have a cut along one side of the patch, that could result in leaking of the fentanyl gel.

More than six lakh prescriptions of Fentanyl patches worth around $100 million were sold in Canada last year, according to drug market research agency IMS Health.