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

Starting date:
August 29, 2013
Posting date:
August 29, 2013
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product withdrawal
Audience:
General Public
Identification number:
RA-35313

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

PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on 282 MEP

August 29, 2013

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

PENDOPHARM and Health Canada would like to inform you of the market withdrawal of 282 MEP®. 282 MEP® will no longer be available in Canada after October 28th 2013.

282 MEP® is used for the treatment of pain with muscle spasm and anxiety. Each 282 MEP® tablet contains meprobamate, acetylsalicylic acid, codeine phosphate, and caffeine.

  • A safety review conducted by Health Canada has concluded that there is a risk of overdose, abuse and misuse with medicines containing meprobamate, such as 282 MEP®.
  • A review of benefits and risks of 282 MEP®, mostly focused on its meprobamate content, found that there was not enough evidence of benefit to continue using this drug.
  • 282 MEP® will be withdrawn from the market effective October 28th 2013.
  • Patients being treated with 282 MEP® should contact their doctor or pharmacist in order to switch to an alternative treatment. Patients should not stop taking 282 MEP® without first speaking to their doctor or pharmacist.

Health Canada has evaluated information on the risk of overdose, abuse and misuse in patients taking 282 MEP® (meprobamate-containing medicine). Meprobamate may cause serious side effects including overdose, loss of consciousness, abuse, addiction and severe symptoms on stopping treatment abruptly (e.g., muscle twitches, hallucinations, seizures). Since the approval of 282 MEP®, other medications have largely replaced its use in Canada and in other countries. After considering this new safety information along with existing information regarding benefits, Health Canada has concluded that the risks of 282 MEP® outweigh the benefits for the treatment of pain with muscle spasm and anxiety.

As of July 30th, 2013, PENDOPHARM has discontinued the sale of 282 MEP®. Distribution of the product will be phased out and 282 MEP® will be unavailable after October 28th, 2013. Following the withdrawal of 282 MEP®, no medications containing meprobamate will be available in Canada. PENDOPHARM has also sent a letter to Canadian health care professionals informing them of this safety information.

Patients should not stop taking 282 MEP® without speaking to their doctor or pharmacist, since stopping treatment abruptly may lead to severe symptoms such as muscle twitches, hallucinations and seizures. Patients should contact their doctor or pharmacist in order to switch to an alternative treatment by October 28th 2013. Patients may contact their pharmacy for the return of unused tablets.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious or unexpected side effects 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

You can report any suspected side effect 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