BFAD issues warning vs anti-smoking drug

MANILA, Philippines – The Bureau of Food and Drugs (BFAD) on Thursday warned the public against a drug used to treat smoking addiction, as it advised patients against taking such medication citing health hazards the drug may pose. BFAD deputy director Joshua Ramos in a radio interview on Thursday discouraged people from taking a prescription drug called Varenicline, saying it triggers unfavorable changes in people’s behavior. Varenicline, which is being sold locally by Pfizer under the brand name Champix, has been in the Philippine counter for 11 years since June 1997. “Ina-advice muna namin na tigilan muna ang paggamit ng Varenicline at magkonsulta sa kanilang mga doctor (We are advising the public to stop taking Varenicline and consult first with your doctors)," Ramos said. The BFAD was prompted to issue the warning following the United States Food and Drug Administration’s health advisory last May, directing health professionals to inform patients about possible behavior changes if the drug is induced. In a statement posted on its website, the BFAD said the drug may induce depression or suicidal thoughts to anyone taking the medication, saying patients need to immediately contact their physicians "if they notice agitation, depressed mood, or changes in behavior that are not typical of them, or if they have suicidal thoughts or actions." While no adverse reaction to the drug has been reported, the BFAD still “decided to issue this warning in the best interest of the patients and the public, in general." BFAD also said it is currently validating and synthesizing all information and studies it has received from the US FDA as well as the drug manufacturer. “Ang analysis natin dito (so far), agad namang mawawala ng epekto noon kapag tumigil (So far, our analysis is that the effects go away once the patient stops taking the drug)," Ramos said. No pullout For its part, Tony Leachon, a Pfizer medical director, said in a separate radio interview that he has met with Ramos Wednesday afternoon to make sure that the BFAD will just “align with the US FDA advisory" and not order a product recall. “Hindi naman po siya tinatanggal dahil wala naman pong reported case ng neuro-psychological data according to BFAD (The drug will not be pulled out from the market because there are no reported cases of neuro-psychological effects)," Leachon said. The Pfizer official stressed the beneficial effects of Varenicline, saying the makers of the drug have been awarded a Nobel Prize in Medicine for Pharmaceutical Industry in 2006. “Kailangan po itong produktong ito kasi (We need this product because) six out of ten deaths in the country is smoking-related... So dapat tignan natin ang risk-benefit ratio bago natin husgahan ang gamut dahil wala naming drugs na libre sa side effects (We have to look at the risk-benefit ration before we pass judgement on drugs because there is no drug that has no side effects)," he added. US FDA advisory Saying that Varenicline can cause a psychiatric illness to reoccur, the FDA in its advisory ordered doctors to ensure that their patients have no mental illness prior to taking the drug. Healthcare professionals, caregivers, and the patients’ families were likewise encouraged to monitor for any symptoms of patients treated with Varenicline. “Ine-encourage din ang mga pasyente na gumagamit nito na i-report nila kung may nararamdaman silang unusual o strange things or mood swings (Patients taking the drug are encouraged to report any unusual or strange things and mood swings)," Ramos said. The US food and drug regulatory agency identified symptoms from taking the drug as the following: * anxiety, nervousness, tension, depressed mood, unusual mood, unusual behavior and suicidal tendencies; * vivid, unusual, or strange dreams; and * impairment of the ability to drive or operate heavy mechanisms. - Mark Merueñas, GMANews.TV