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282 MEP (meprobamate-containing medicine) - Market Withdrawal, Effective October 28, 2013 - For Health Professionals

Starting date:
August 29, 2013
Posting date:
August 29, 2013
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product withdrawal
Audience:
Healthcare Professionals
Identification number:
RA-35311

This is duplicated text of a letter from PENDOPHARM, Division of Pharmascience Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on 282 MEP

August 29, 2013

Dear Health Care Professional,

Subject:     Market Withdrawal of 282 MEP® (Meprobamate-Containing Medicine) DIN 02238646

PENDOPHARM, in collaboration with Health Canada, would like to inform you of the market withdrawal of 282 MEP®. Effective October 28th, 2013, the DIN for 282 MEP® will be cancelled. As of July 30th, 2013, PENDOPHARM has discontinued the sale of 282 MEP®.

282 MEP® is indicated for the relief of pain of various origins, accompanied by muscle spasm and anxiety.  Each 282 MEP® tablet contains as medicinal ingredients acetylsalicylic acid (350 mg), codeine phosphate (15 mg), meprobamate (200 mg), and caffeine (15 mg, equivalent to 30 mg caffeine citrate).

  • Following the review of safety and efficacy information for 282 MEP® mostly focused on its meprobamate content, Health Canada has concluded, in light of the risk of overdose/abuse/misuse, that the benefit-risk profile is no longer considered favourable.
  • 282 MEP® will be withdrawn from the market effective October 28th, 2013.
  • Patients being treated with 282 MEP® should be switched to an alternative treatment.

Health Canada has evaluated information on the risk of overdose/abuse/misuse in patients treated with 282 MEP® (meprobamate-containing medicine). Meprobamate has a narrow therapeutic index and may cause serious adverse events (including overdose, loss of consciousness, abuse, pharmacodependence and withdrawal symptoms), even under normal conditions of use. Since the approval of meprobamate, other medications (e.g., muscle relaxants, anxiolytics, antidepressants) have largely displaced the use of meprobamate in Canada and in other countries. Taking this new safety information and the available efficacy data into account, Health Canada has concluded that the risks of 282 MEP® (meprobamate-containing medicine) outweigh the benefits under normal conditions of use.

As of July 30th, 2013, PENDOPHARM has discontinued the sale of 282 MEP®. Distribution of the product will be phased out and the DIN for 282 MEP® will be cancelled on October 28th, 2013. Following the discontinuation of 282 MEP®, no medications containing meprobamate will be available in Canada.

Health care professionals should no longer prescribe 282 MEP® and are advised to transition their patients to alternative therapies before October 28th, 2013. Pharmacists are advised that dispensing should cease by October 28th, 2013, since the DIN will become inactive on that date. To ensure full inventory depletion, 282 MEP® should be removed from pharmacy inventory by October 28th, 2013. Pharmacies and wholesalers may contact PENDOPHARM for the return of unused tablets.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Any case of serious or unexpected adverse reactions in patients receiving 282 MEP® should be reported to PENDOPHARM or Health Canada.

PENDOPHARM, Division of Pharmascience Inc.
6111 Royalmount Avenue, Suite 100
Montréal, Québec, H4P 2T4
medinfo@pendopharm.com
Tel: (514) 344-0764 / 1-888-550-6060

To correct your mailing address or fax number, contact PENDOPHARM.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
     
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

original signed by

Leonard Neirinck, Ph.D.
Senior Vice President, Scientific Affairs