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Rinfocan- Prescription Drug Information for Canadians

On November 24 1998, the Therapeutic Products Programme (Health Canada) took regulatory action to suspend the sales of TASMAR (tolcapone) due 8 emerging and serious safety concerns regarding liver toxicity. A review of the safety information led to the conclusion that TASMAR was not considered safe under the represented use.

Further to the "Dear Healthcare Professional" and "Dear Pharmacist" letters of November 23, 1998 issued by Hoffmann La Roche, the manufacturer of TASMAR (tolcapone), the Therapeutic Products Programme is advising you of the following information regarding the continued availability of TASMAR through the Speeial Access Programme (SAP).

The Special Access Programme (SAP) has a mandate to provide access to drugs not currently available on the Canadian market for compassionate purposes.

TASMAR will continue to be made available through the Special Access Programme for:

a) the safe discontinuation of patients from TASMAR treatment

b) in extraordinary cases involving patients already on TASMAR therapy and in whom, in the opinion of their physician, the benefits outweigh the risks.

In either case the continued treatment with TASMAR should only be undertaken by neurologists with special expertise in Movement Disorders or under their supervision.

TASMAR is not available for new patients at this time

PROCEDURES FOR PHYSICIANS TO OBTAIN TASMAR THROUGH THE SAP

1. Physicians wishing either to discontinue or continue TASMAR treatmemt for patients described above, should ensure that:

a) the patient has been informed of the risks and benefits and has consented to the proposed treatment plan and;

b) there is a record of such consent

2 Physicians should call (613-941-2108) or fax (613-941-3194) the following information to SAP:

a) initials, gender and age of the patient;

b) indication for the use of the drug i.e for discontinuing or continuing TASMAR treatment,

c) dosage regimen;

d) total quantity of drug requested;

e) name and address of the prescribing physician;

3. Requests will be considered for authorization within 24 hours of receipt.

4. Requests authorized for release through SAP will be forwarded to Hoffmann-La-Roche for action. As with all SAP authorizations the manufacturer has the final word on drug availability and delivery.