Health Canada

Health Canada

June 26, 2009 12:53 ET

Warning: Pms-Phenobarbital (60 mg) Being Recalled in Canada Due to Risk of Accidental Overdose

OTTAWA, ONTARIO--(Marketwire - June 26, 2009) - Health Canada is warning consumers that all lots of the prescription drug pms - Phenobarbital tablets in the 60 milligram (mg) format (DIN 00178810) are being recalled because some oversized tablets were recently found on the Canadian market. The oversized tablets were found to contain more Phenobarbital than the label indicates, exposing patients to the potential risk of accidental overdose. The Canadian distributor, Pharmascience Inc. of Montreal Quebec, has initiated a recall of all lots presently on the market.

Phenobarbital is widely used as an anticonvulsant for the treatment of seizure disorders, and it is also used to treat anxiety and sleep related disorders as it has sedative and hypnotic properties.

Health Canada advises consumers currently using pms -Phenobarbital 60mg to return this product to their pharmacist for a replacement. Consumers should not stop taking their medication without consulting a health care professional, as abrupt discontinuation of this medication can cause symptoms of withdrawal (such as irritability, headache, dizziness, sweating, tremors, nausea, vomiting, abdominal cramps, weight loss or anorexia, nightmares, insomnia) and, if used to treat seizures, can result in an increase in seizures.

The oversized tablets may contain significantly more phenobarbital than the 60mg indicated on the label. Symptoms of an overdose may include uncontrolled eye movements, lack of muscle coordination, impaired speech, extreme drowsiness, decreased breathing and heart rate and may begin within 1-2 hours after taking a Phenobarbital overdose. An overdose may be life threatening and can result in a coma and/or cardiac arrest.

In the event of an overdose or if experiencing serious side effects consumers are advised to contact emergency services. Consumers who have used this product and are concerned about their health should contact their health care practitioner for advice. Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To date, no adverse reactions from the use of pms - Phenobarbital 60mg tablets have been reported to Health Canada.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

- Report online (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) at the MedEffect™ Canada Web site (www.healthcanada.gc.ca/medeffect)

- Call toll-free at 1-866-234-2345

- Complete a Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and either:



- Fax toll-free to 1-866-678-6789
- Mail to: Canada Vigilance Program
Health Canada
AL 0701C
Ottawa, ON K1A 0K9


To have postage pre-paid, download the postage paid label (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affranchi-eng.php) from the MedEffect™ Canada website (http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php) The Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php) and the adverse reaction reporting guidelines may also be obtained via this website.

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Contact Information

  • Media Inquiries:
    Health Canada
    613-957-2983
    or
    Public Inquiries:
    613-957-2991
    1-866-225-0709