Advisory
2005-28
April 22, 2005
For immediate release
Health Canada advises consumers to verify their medication
OTTAWA - Health Canada is advising Canadians, especially those with asthma, who
use any of the following prescription drugs - Avandamet, Avandia, Coreg, Paxil, Paxil CR, Relafen
(distributed by GlaxoSmithKline), and ratio-Paroxetine (distributed by ratiopharm) - to make sure
that their medication contains the correct tablets.
Because of problems with the packaging process at the Puerto Rico manufacturing facility for these
drugs, there is a small chance that a tablet of another drug could be present in a patient's prescription.
There have been no reports in Canada of incorrect tablets being found in prescriptions for any of
the above named drugs. However, consumers are advised not to take any medication that is of a different
size, shape or colour from the medication that they normally take or that is different from the other
pills in the bottle or package that they receive from their doctor or pharmacist.
Patients are advised to continue to take their prescribed medications as directed. Patients should
consult their pharmacist or their physician if they have any concerns.
People with asthma should be particularly careful as accidentally taking a Coreg tablet could result
in an increased risk of a serious asthma attack. Coreg is used in the treatment of heart failure
and is not prescribed to asthmatic patients, due to the risk of a serious asthma attack. The risk
to other patients of taking a stray tablet of another medication is believed to be low. However,
Health Canada cannot predict how an individual may react to another medication.
In addition, some prescriptions of Paxil CR may contain broken or split tablets. These tablets do
not pose a significant health risk, but patients should not consume any broken or split tablets since
they may not contain any active ingredients or may not provide a controlled-release effect.
Pharmacists were advised on April 15 to dispense these drugs manually, rather than with an automated
system. Patients using any of these drugs are advised to carefully check their prescriptions for
the presence of any broken or unusual tablet.
Avandamet, Avandia, Coreg, Paxil, Paxil CR, and Relafen are distributed by GlaxoSmithKline and come
in bottles or blister packs. ratio-Paroxetine is distributed by ratiopharm inc. and comes in bottles
and blister packs. Paxil and ratio-Paroxetine in blister packs are not affected by this advisory.
Avandia and Avandamet are used in the treatment of Type II diabetes. Coreg is used in the treatment
of mild, moderate or severe heart failure. Paxil, Paxil CR and ratio-Paroxetine are used to treat
depressive disorders. Relafen is used to relieve pain and inflammation in patients with rheumatoid
arthritis and osteoarthritis.
GlaxoSmithKline and ratiopharm inc. are taking steps at their respective Canadian distribution facilities
to reduce the likelihood of the wrong tablets being present in any of these drugs shipped to Canadian
pharmacists.
Health Canada is working with GlaxoSmithKline Inc. and ratiopharm inc. to monitor the quality of
the drug supplies as they are made available in Canada.
Note: Health Canada issued another advisory on this topic on May 12, 2005. To access this advisory, visit:
www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/2005_35_e.html
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To view the advisory to health professionals follow these links:
Media Inquiries:
Jirina Vlk
Health Canada
(613) 957-2988
Public Inquiries:
(613) 957-2991
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