CANADA MOVING SELDANE AND HISMANAL BEHIND THE COUNTER

CANADA MOVING SELDANE AND HISMANAL BEHIND THE COUNTER in pharmacies and adding warning label stickers to the nonsedating antihistamines, the national Health Protection Branch announced July 15. The Canadian FDA equivalent "has recommended to provincial Registrars of Pharmacy that these products be moved to the pharmacist-controlled areas (behind the counter) of all pharmacies." Marion Merrell Dow's Seldane (terfenadine) and Janssen's Hismanal (astemizole) are marketed OTC in Canada. The new Hismanal warning label will include the statements: "Do not exceed recommended dosage" and "This drug should not be used by individuals with heart disease, or metabolic disease (disturbance in electrolyte balances)." In addition, the warning label will direct consumers to "consult your physician or pharmacist prior to use if you are taking any prescription medications," even though there have been no official reports of drug interactions with the drug. The new Canadian Seldane labeling will resemble new labeling now being developed in the U.S. HPB said its recommendation to move the products behind the pharmacy counter was based on the fact that "while most individuals can use antihistamines without problems, there is growing evidence internationally of rare adverse effects in some individuals." There have been no deaths reported in Canada tied to Seldane or Hismanal, Canadian authorities said. Canada's action follows by one week FDA's decision to relabel Seldane with a boxed warning describing rare cardiovascular adverse events, including death, associated with use of the nonsedating antihistamine and contraindicating against its concomitant use with erythromycin or Janssen's Nizoral ("The Pink Sheet" July 13, p. 9). MMD said that it would be notifying regulatory agencies around the world of the potential drug interactions. The U.K. is the only other country where Seldane is available without a prescription. Unlike Canada, FDA has not required any changes in Hismanal labeling to date. However, the agency has said that it will review all antihistamine products for serious side effects and drug interactions. The Canadian HPB noted that changes in Hismanal's OTC status and labeling were prompted by reports that "persons with specific heart conditions or metabolic diseases, which affect the electrolyte balance, can experience irregular heartbeats" when taking the antihistamine. The Canadian authorities have requested that the companies send out "Dear Doctor" and "Dear Pharmacist" letters. Janssen sent letters to 50,000 Canadian physicians and pharmacists on July 17. The letter notes that "the cardiac events described with Hismanal have been very rare instances of cardiac arrest, QT interval prolongation, torsades de pointes and other ventricular arrhythmias." The letter also emphasizes that "astemizole and terfenadine are different compounds and there are differences in their side effects." It notes that there is no labeling regarding Hismanal and erythromycin or ketoconazole interactions. The Canadian action leaves Schering-Plough's Claritin (loratadine) as the only nonsedating antihistamine available in the self-selection section of Canadian pharmacies. Claritin was recommended for approval by an FDA advisory committee in 1987 and was largely cleared of carcinogenicity concerns by a 1991 advisory committee ("The Pink Sheet" June 24, 1991, p. 7). Unless the U.S. were to adopt a third class of drugs it seems unlikely that Seldane, and possibly Hismanal, will ever go OTC in this country. At a July 13 roundtable for trade press, FDA Commissioner Kessler was asked about OTC Seldane. While he could not comment on the specific application, Kessler said: "We cannot put drugs over the counter if there are any serious or life- threatening adverse reactions that could be associated with them even though they are rare."

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