News Release
1997-62
November 18, 1997
Health Canada reclassifies terfenadine and astemizole as prescription drugs
OTTAWA - Health Canada announced today that terfenadine and astemizole, antihistamines for allergy relief, are being reclassified as prescription drugs.
This action is being taken as part of the Therapeutic Products Directorate's ongoing risk\benefit analysis of these drugs. A detailed letter has been sent today to all Canadian doctors and pharmacists informing them of this decision.
Though most consumers have used these products successfully for many years without any adverse effects, the number of drugs and/or foods that has been reported to have interacted, or that has the potential to interact, with terfenadine and astemizole is now large enough to warrant the safeguard of prescription status. Individuals can still obtain these products with a prescription from their doctors or they can ask their pharmacists about alternative products. Many other antihistamines remain available on the non-prescription market.
The major brand of terfenadine available in Canada is Seldane. A number of generic and house brands of terfenadine also are on the market. The name terfanadine is listed on the label. Astemizole is sold in Canada under the brand name Hismanal.
Doctors and pharmacists have received updated prescribing information to reflect the new information about drug and food interactions with terfenadine and astemizole. There will be an additional warning not to take terfenadine at the same time as consuming grapefruit juice.
Terfenadine and astemizole have been available in Canada as non-prescription drugs since the early 1980s. In 1992, both drugs were placed behind the counter (pharmacist controlled sale) when it became evident that elevated blood levels were associated with rare, but potentially fatal, disturbances in heart rhythm. At that time, known drug-drug interactions were limited to certain antifungal and antibiotic drugs.
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Media Inquiries:
Bonnie Fox-McIntyre/Monique Renaud-Gagné
Health Canada
(613) 957-1588
Public Inquiries:
(613) 957-2991
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