Experts Warn ‘Quit Smoking’ Drug Has Side Effects
DUBAI — Smokers who wish to stub the habit have been cautioned by the health authorities against possible serious side effects of Champix, the smoking cessation drug.
Doctors have also been asked to warn patients and their families of the possible side effects and tell them to seek immediate medical help in case they notice changes in behaviour, such as depression, hostility and suicidal tendency. Among other side effects are nausea, aggression and insomnia.
The local warning follows reports from international studies published in Australia and New Zealand that suggest a relation between the drug and mental problems.
Earlier this month, the US Food and Drug Administration called for a black-box warning (FDA’s strongest safety warning) over possible serious side effects but did not suggest a ban saying that consumers and doctors still have to weigh the benefits versus the risks when taking the drug.
Sources from the Drugs Control Department in the UAE Ministry of Health said the country is following the FDA warnings on the drug closely.
In the UAE, Champix (varenicline) is being marketed by Pfizer since 2007. Though a controlled drug, it is sold freely over-the-counter and is prescribed by local doctors to help people quit smoking since it relieves the cravings and withdrawal symptoms.
An alternative smoking cessation drug, Zyban, available locally, already carries a similar warning.
Champix is well known and people ask for it by name, according to pharmacies. The week-long starter pack is available for Dh198 while the remaining three-month course can be got for Dh444 each.
“As doctors we have to issue warning for all possible side effects of any medicine but in certain drugs, the warning should be clearly explained,” said Dr Ghada Fahmy, medical director and in-charge of the ministry’s Smoking Cessation Clinic at Ittihad Health Centre.
“Doctors should also know the patient’s history before recommending the medicine,” she added.
The UAE is currently in the process of drafting an anti-smoking law. As part of the regulations, the ministry has set up a number of smoking cessation clinics in Dubai and the Northern Emirates to encourage people to quit smoking. However, Champix is currently not part of the treatment course at these centres.
“We are using nicotine replacement therapies (patches and gum) though doctors at the cessation clinics do prescribe Champix to their patients,” said Dr Wedad Maidoor, head of the National Tobacco Control Programme in the ministry.
However, experts also say that any medicine related to the central nervous system can have serious side effects.
“Side effects, such as depression, may not be as dangerous as nicotine,” said Dr Essa Al Jakka, deputy director of foreign relations and international organisations in the Ministry of Health.
“People have to tolerate the changes,” said the former head of the Drugs Control Department.
Pfizer, in a statement, said that all drugs have benefits and risks. “Through March 2009, approximately 11 million people have been prescribed Champix worldwide. The safety profile of Champix remains favourable. All medicines have both benefits and risks. The benefits of Champix outweigh its risks for many patients,” said Dr Yasser El Dershaby, Pfizer’s medical director, Gulf.
“The updated Champix labeling in the USA provides physicians and patients with information about the safe use of Champix and the complexity of the quitting process.”
However, the company did not say if any warning update on the drug was being done locally.
Khaleejtimes
