Pfizer shrugs off FDA, BFAD warning on anti-smoking drug

MANILA, Philippines - Pfizer is upbeat on its anti-smoking drug that targets 25 million Filipino smokers and sold locally as Champix, despite the US Food and Drugs Administration’s (FDA) warning on its side effects. "Studies show that 44% [of those who reported side effects] were with depressed mood already before taking Champix," Pfizer Medical and Regulatory Affairs Director Anthony C. Leachon told a briefing Thursday. "Let us follow the regulation of the Bureau of Food and Drugs," he added. "If it can be bought in the market, it means it (Champix) has no defects." Since the introduction of Chantix — the brand name used in the US — in May 2006 to December 2007, the FDA has received 227 reported cases of suicidal acts, thoughts or behaviors; 297 cases of possible psychosis; and 525 cases of aggression from patients who have used the drug. Like the FDA, the BFAD has warned against the anti-smoking drug given its side effects that trigger severe changes in a patient’s mood and behavior. Pfizer, the world’s biggest drug company, has listed nausea, constipation, sleeping problems and vomiting as possible side effects of Chantix/Champix. "I have asked around in Europe and we have not seen the same picture that was reported in the US," said Karl Fagerstrom, director of the Smoker’s Information Center based in Helsingborg, Sweden, and a proponent of the drug. Introduced as Champix in August last year, Pfizer’s anti-smoking drug aims to cash in on some 25 million smokers in the Philippines, 70% of whom desire to quit at least one point in their lives. On average, a day of medication costs P70 for two 0.5 milligram of Champix, which customers can buy at a discount at P42 using Pfizer’s discount card, Mr. Leachon said. In the first three days, patients should take one half-a-milligram tablet daily and increase it to two tablets on the fourth up to the seventh day. After a week, the regular dose is two one-milligram tablets daily. Compared with nicotine substitute drugs that replace the nicotine in cigarettes with similar nicotine gums, nicotine straps or placebo, Champix works by blocking nicotine receptors in the brain. Its makers received the Nobel Prize in pharmaceutical medicine last year. According to the Department of Health, smoking-related diseases cause seven out of 10 deaths in the country. It is the second leading cause of death, next to heart ailments. Mr. Leachon advised doctors to look at package labels to know who can safely use the drug. Mr. Fagerstrom added that doctors must know the history of patients before prescribing the anti-smoking drug. — Neil Jerome C. Morales, BusinessWorld