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Important Safety Information Regarding The Discontinuation Of Sales - Linnefazodone In Canada: Letter To Pharmacists And Wholesalers

Date: 2003-11-05

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The Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) post safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties. Although MHPD, TPD and BGTD approve therapeutic products, MHPD, TPD and BGTD do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Linson Pharma.
Contact the company for a copy of any references, attachments or enclosures.

IMPORTANT SAFETY INFORMATION REGARDING THE DISCONTINUATION OF SALES - LinNefazodone IN CANADA: LETTER TO PHARMACISTS AND WHOLESALERS

The following is duplicated text of a letter from Linson Pharma directed to pharmacists and pharmaceutical wholesalers. This notification is further to a Health Professional Communication issued by Linson Pharma on October 2, 2003.

Linson Pharma

October 2003

Dear Pharmacist / Wholesaler,

Immediate Attention Required
All Lots of LinNefazodone 50 mg, 100 mg, 150 mg, 200 mg
Discontinuation of sales: LinNefazodone (nefazodone HCl)
PRODUCT STRENGTH PRODUCT CODE DIN UPC
LinNefazodone*
50 mg
122411
02237397
623136000180
LinNefazodone*
100 mg
122511
02237398
623136000197
LinNefazodone*
150 mg
122611
02237399
623136000203
LinNefazodone*
200 mg
122711
02237400
623136000173

* nefazodone hydrochloride, USP

As mentioned in the enclosed letter, as of November 27, 2003, the sales of LinNefazodone (nefazodone HCl) will be discontinued in Canada. In order to enhance patient safety and allow physicians the opportunity to counsel their patients concerning alternate treatment options, the product should be made available until November 27, 2003, at which time all distribution and dispensing must cease, so that no further sales should occur after November 27, 2003. In order to assist physicians in protecting the well being of their patients during this transition period, these products should be made available until November 27, 2003 and no product should be returned to Linson Pharma (Linson) at this time. Linson will be sending a second letter on November 27+1 day which will include a fax back form to identify all remaining inventory and a product credit form.

Please inform your customers that they should not discontinue taking LinNefazodone without first consulting with their physician. Please immediately refer any customer seeking LinNefazodone to their doctor for consultation.

If you have any questions about this discontinuation of sales, please call our Customer Services at 1-800-267-0005. We regret any inconvenience and appreciate your cooperation.

Any suspected adverse incident can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.