[johnxarce]

BFAD issues advisory against possible dangers of anti-smoking drug

By Francis Jay M. Bilowan

MANILA, June 12

The Bureau of Food and Drugs (BFAD) on Thursday issued a warning against an anti-smoking drug due to its adverse side effects that triggers severe changes in a patient?s mood and behavior.

In its advisory, BFAD director Leticia-Barbara Gutierrez said they were prompted to issue the warning following the United States Food and Drug Administration?s (FDA) health advisory last May, which ?alerted patients, caregivers and healthcare professionals on important changes? to the drug called Varenicline, Chantix or Champix which brand name is locally sold in the Philippines by the company Pfizer.

Champix has been in the Philippine counter for 11 years since it was introduced June 1997.

Gutierrez said they advise the public and those already using the drug to stop taking the drug or consult first with doctors before taking such drug.

The BFAD said ?patients who are taking Varenicline to stop taking the drug and their physicians of 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 chief said although there is no case reported on such behavioral change the drug may induce to patients, they still decided to issue this warning in the best interest of the public in general.

The US-FDA last May 16 has the requested Pfizer to update their prescribing information and include warnings about the possibility of severe changes in mood and behavior in patients taking Varenicline.

Other than those mentioned, the FDA noted safety information on Champix as the latter may cause worsening of a current psychiatric illness even if it is currently under control and may cause an old psychiatric illness to reoccur.

Symptoms of the adverse effect may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide.

As what the FDA noted, the BFAD advised patients taking Chantix should immediately report to doctors changes in mood and behavior; the experience of vivid, unusual, or strange dreams; or experience of impairment of the ability to drive or operate heavy machinery.

The advisory said ?while Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert patients that they are possible.?

The BFAD said it is currently validating and synthesizing all information and studies it has received from the US FDA as well as the drug manufacturer.

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.

Meanwhile, Dr. Anthony Leachado, Pfizer medical regulation affairs officer, said Thursday the BFAD issued advisory is aligned with the FDA advisory to caution patients who are at risk for taking the drug.

Leachon also refuted reports the BFAD will order a product recall because as of present, there is still no reported case of a neuropsychiatric incident caused by the drug.

?What I?ve learned is based on the monitoring of the BFAD, there is still no case of neuropsychiatric problems as caused by the drug. Authorities are still conducting surveillance studies on the matter and for the meantime, we will place warning labels regarding the advisory on the packaging of the drug,? he said.

He also cleared that Champix is not sold over the counter as what has been previously reported that it can be purchased in drugstores for P1,800 per 20 tablets even without prescription.

?Champix is a prescription-based product. This drug is not a defective drug. It is safe but only doctors can prescribe it and patients should be properly informed regarding its use,? 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.

Several lawmakers earlier asked the Department of Health and BFAD to investigate the side effects of Varenicline in line with the advisory of the US-FDA.

The senators were concerned the drug can cause mental illness and can cause suicidal tendencies to patients as the FDA report said there have been 28 reported cases of suicides in the US where victims reportedly took the drug.

Varenicline, when induced, goes to the brain?s nicotine receptor and blocks it to reduce a patient?s craving on nicotine. It also decreases the pleasurable effects of cigarettes and other tobacco products, and through these mechanisms, it can assist some patients in stopping smoking.(PNA)