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Update on the Availability in Canada of Bicillin (benzathine penicillin G) for the Treatment of Syphilis

In January 2002, Wyeth-Ayerst Canada Inc. formally notified their stakeholders of their unilateral decision to discontinue the distribution of Bicillin L-A (injectable benzathine penicillin G) in Canada, citing an inability to procure a long-term reliable supply of the product. The announcement was the culmination of 9 months of uncertainty about the future of the medication on the Canadian market. As a result of the company's actions, the medication is now available only from non-Canadian sources.

As indicated in the Canadian STD Guidelines (which are intended to assist in the treatment and appropriate management of sexually transmitted diseases in Canada), benzathine penicillin G remains the treatment of choice for most patients with syphilis in Canada. Any suggested therapeutic alternatives have significant adherence and tolerance issues as well as less available efficacy data and clinical experience. A reliable supply of benzathine penicillin G is of particular importance in Canada at this time given the recent regional outbreaks and increasing national rates of syphilis.

Although the procurement of medication falls beyond the scope of the Division of Sexual Health Promotion and STD Prevention and Control, the Division is continually taking steps to address the public health care crisis created by the discontinuation of Bicillin. In addition to facilitating communications between stakeholders and other involved parties, the Division was able to obtain information on alternative worldwide distributors of Bicillin and provide information to the Provincial and Territorial STD Directors on how the medication could be ordered from these manufacturers. The Therapeutic Products Directorate (TPD), in another branch of Health Canada, is responsible for the regulation of pharmaceutical drugs, medical devices and other therapeutic products available to Canadians. Included in TPD is the Special Access Programme (SAP), which is mandated to provide access to non-marketed drugs to practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, are unavailable or offer limited options.

Despite the fact that Bicillin availability in Canada has been addressed in the short-term, a long-term solution to the problem has yet to be identified. The Division of Sexual Health Promotion and STD Prevention and Control will continue to work together with all involved parties until the availability of the medication for the foreseeable future is certain.

Related Links:

STD Epi Update on Infectious Syphilis in Canada: http://www.phac-aspc.gc.ca/publicat/epiu-aepi/std-mts/infsyph_e.html