BFAD warns public vs anti-smoking drug

The Bureau of Food and Drugs (BFAD) warned the public yesterday against varenicline, a drug used to treat smoking addiction after the product was found to cause changes in the patient’s behavior.

In an advisory posted on its website, the BFAD said patients taking varenicline should stop taking the drug and 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.”

The BFAD noted that there has not been any report of “adverse reaction (or) event among local patients” but it decided to issue the warning in the “best interest of the patients and the public in general.”

Drug firm Pfizer sells varenicline as a prescription drug in the Philippines and Canada under the brand name Champix, and in the US as Chantix. Varenicline works by activating nicotine receptors in the brain while blocking nicotine from attaching to them. These actions limit the release of dopamine, the substance that gives the pleasurable effects of nicotine.

In a statement, Pfizer said the benefits of the drug “outweigh the risks” and that the BFAD “has determined Champix to be a safe and effective treatment for smoking cessation.”

In a telephone interview, BFAD deputy director Joshua Ramos said the bureau has not ordered varenicline to be pulled from the market, but may do so if the United States Food and Drug Authority issues such an order.

According to Dr. Maricar Limpin, president of the Framework Convention on Tobacco Control Alliance – Philippines, some smokers who wish to quit the habit need medicines “to take care of the withdrawal syndrome,” which she said is “the most difficult part of quitting.”

Those with withdrawal syndrome usually experience irritability, restlessness, drooling and tremors.

Meanwhile, Daniel Dimagiba, Air Transportation Office (ATO) executive director, said they have yet to be advised by the US Federal Aviation Authority or the International Civil Aviation Organization about any ban or prohibition of the use of varenicline.

Dimagiba said that the ATO was ready to comply in the event they receive any directive against the use of any drug by pilots and air controllers. In the meantime, he said that he may order ATO’s medical staff to look into the issue.

In their website, the FAA was reported to have issued the ban against varenicline last May 23 less than 48 hours after a medical safety group, the Institute for Safe Medication Practices, released a study they made on the drug where it found evidence of occurrence of seizures, loss of consciousness, heart attacks, vision problems, and various psychiatric problems in individuals who use varenicline.     – With Rainier Allan Ronda