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Health Canada Endorsed Important Safety Information Regarding ratio-Paroxetine – ratiopharm Inc. – For Health Professionals
- Starting date:
- April 14, 2005
- Posting date:
- April 20, 2005
- Type of communication:
- Dear Healthcare Professional Letter
- Source of recall:
- Health Canada
- Labelling and Packaging
- Healthcare Professionals
- Identification number:
This is duplicated text of a letter from ratiopharm Inc.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information regarding ratio-PAROXETINE
April 14, 2005
Subject: Concerns with Packaging of ratio-PAROXETINE
Dear Health Care Professional,
ratiopharm Inc. (ratiopharm), following discussions with Health Canada, would like to inform you about concerns regarding the packaging of ratio-PAROXETINE in bottles. This concern does not affect the quality of ratio-PAROXETINE tablets. It is important to note these concerns present an extremely low risk to patients.
Potential for Stray Carvedilol Tablets in Bottles of ratio-PAROXETINE
There is a remote possibility that bottles of ratio-PAROXETINE (paroxetine hydrochloride) may contain a stray tablet of carvedilol. ratio-PAROXETINE packaged in blisters are not subject to this advisory. ratiopharm wants to emphasize that there have been no reported incidents of a carvedilol tablet being found in a bottle of ratio-PAROXETINE and this letter is being sent as a precautionary measure.
Please note that carvedilol, an alpha and beta blocking drug, is indicated for the treatment of mild, moderate or severe heart failure of ischemic or nonischemic origin. Carvedilol is contraindicated in patients with bronchial asthma and related bronchospastic conditions. Severe bronchospasm has been reported in some asthmatic patients exposed to a single dose of carvedilol.
The potential for an asthma patient to receive a stray carvedilol tablet is very remote, so it is very important that patients continue to take their current therapies as directed by their health care professionals and not discontinue treatment of ratio-PAROXETINE.
As an added precaution ratiopharm asks all pharmacies that use automatic dispensers (counting machines) to either manually dispense or visually inspect ratio-PAROXETINE from the batch numbers listed in the table below before providing them to their patients. There are significant differences in colour and shape, between carvedilol and ratio-PAROXETINE. Carvedilol tablets are white, film-coated, oval tablets.
|Strength||Lot Number||Pack Size||Pack||Expiry Date|
If a pharmacist or any pharmacy personnel should discover a tablet of a different shape, size or colour than the medication being dispensed, he or she should contact the Customer Service Department of ratiopharm at 1-800-337-2584 immediately.
Please be assured that ratiopharm is working with Health Canada to resolve this issue as quickly as possible. ratiopharm has taken action to implement corrective measures. ratiopharm remains committed to product quality and patient safety, and we regret any inconvenience this temporary situation may cause. Should you have any further questions, please contact ratiopharm Customer Service at 1-800-337-2584.
The identification, characterization and management of drug-related adverse events are dependent on the active participation of health-care professionals in adverse drug reaction reporting programs. Healthcare professionals are asked to report any suspected adverse reactions in patients receiving ratio-PAROXETINE directly to ratiopharm or Health Canada at the following addresses:
6975 Creditview Road, Unit 5
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
For other inquiries, please refer to contact information.
Drug Compliance Verification & Investigation Unit
Tel/Tél: (613) 941-3967
Fax/Téléc.: (613) 952-9805
original signed by
Vice-President, Development Management & Government Affairs
- Date modified: