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Archive – Update to April 22, 2005 Advisory Entitled: Health Canada Advises Consumers to Verify Their Medication

Starting date:
May 12, 2005
Posting date:
May 12, 2005
Type of communication:
Information Update
Source of recall:
Health Canada
Important Safety Information, Labelling and Packaging
Healthcare Professionals, General Public
Identification number:

Health Canada is providing an update to its advisory issued on April 22, 2005, which addressed problems with the packaging process for drugs produced at a Puerto Rico manufacturing plant. Canadians were advised to verify that their prescriptions of Avandamet®, Avandia®, Coreg®, Paxil®, Paxil CR®, Relafen®, and/or ratio-Paroxetine®, contained the correct tablets and did not contain broken or split tablets.

On May 3, 2005, Health Canada issued a 2005 Establishment Licence to GlaxoSmithKline Inc. (GSK) that does not include GSK's manufacturing facility in Puerto Rico. An assessment determined that the facility, at this time, does not comply with Good Manufacturing Practices (GMPs) set out in the Food and Drug Regulations. Health Canada, GSK, and ratiopharm Inc. are continuing to work to resolve these issues. All other GSK facilities referenced on the licence are considered compliant by Health Canada.

As a result of Health Canada's regulatory action, GSK will no longer be allowed to import Coreg® and Relafen® manufactured at the Puerto Rico facility, until the site is shown to be compliant with Canadian GMP requirements. These drugs have generic substitutes that can be used in a patient's continuing treatment. Health Canada has directed GSK to not release their current inventory stocks of Coreg® and Relafen®. Before these stocks can be released for sale in Canada, GSK has been asked to submit to Health Canada a proposal on how they are addressing any possible risks. Health Canada will review the proposal submitted by the company before making a decision on the release of these products.

For the next two months, Paxil®, and ratio-paroxetine® will be allowed into Canada, in order to ensure patients do not experience a disruption in their treatment, on condition that GSK and ratiopharm conduct more tests on these drugs prior to their release to the Canadian market.

Avandamet®, Avandia® and Paxil CR®, which do not have generic substitutes, will be allowed to be imported into Canada in order to allow patients using these products to continue their treatment safely. GSK is required to continue to perform increased testing on these drugs prior to their release to the Canadian market. Health Canada will verify additional testing by GSK and ratiopharm of drugs from the Puerto Rico facility to ensure their quality.

Although the risk is low, Canadians should continue to check their prescriptions for these drugs to ensure there are no tablets of another drug and that there are no broken or split tablets. Patients are advised to continue to take their prescribed drugs as directed. On April 15, 2005, pharmacists were advised to dispense these drugs manually, rather than with automated systems. Pharmacists should continue to dispense these drugs manually until advised by GSK that there are no more supplies of these drugs in distribution. Stray or broken tablets should be returned to a pharmacy for proper disposal and should not be thrown in the garbage or flushed down a toilet or a sink.

An establishment licence is required for Canadian companies involved in the activities of importing, distributing, packaging, labelling, fabricating and testing or wholesaling drug products. A company cannot import drug products from a foreign site that is not listed on its Establishment Licence. In order to have a foreign site listed on a Canadian company's Establishment Licence, it must provide evidence that the foreign site meets Canadian GMPs.

Health Canada continues to work with the companies so Canadians will continue to have a supply of safe, effective and quality drugs.

The Dear Healthcare Professional letters by ratiopharm and GSK can be found at:

  • Health Canada Endorsed Important Safety Information Regarding Avandamet®, Avandia®, Coreg®, Paxil®, Paxil CRTM, and Relafen®
  • Health Canada Endorsed Important Safety Information regarding ratio-PAROXETINE

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