Not The FDA approved Zyban in 1997 for smoking cessation. It is available by prescription only. Zyban Sustained Release is a nicotine free tablet.
Media reports have questioned the safety of the anti-smoking drug, Zyban. Here we look at the treatment's pros and cons.
Risk of Zyban versus risk of smoking
Zyban is a relatively new drug in the UK, where it became available on the NHS in June 2000. It is one of many anti-smoking products available, but it is a non-nicotine treatment, unlike nicotine replacement therapies (NRT) such as nicotine patches.
As with any new drug, Zyban will be monitored for at least two years. According to the Committee on the Safety of Medicines (CSM) which monitors reactions to drugs, around two percent of adverse reports they receive for all medicines result in death. For Zyban, the proportion of fatalities is much lower - less than one percent.
Professor Alasdair Breckenridge, chair of the CSM, said: "Zyban is used by patients who are put at risk because of smoking and therefore reports of deaths of patients receiving Zyban are to be expected." And as the number of patients prescribed the drug increases, so will the number of reported side effects.
Around 13 million adults in the UK smoke cigarettes and studies conducted by Action on Smoking and Health (ASH) show that about 70 percent of current smokers would like to give up altogether. The habit kills around 120,000 people in the UK every year.
Clive Bates, director of ASH, told BUPA: "There has been a lot of negative hype about Zyban that has greatly exaggerated the dangers of the drug. Yes, there are serious side effects, such as seizures. But when people experience these it's because they've either been very unlucky or, more likely, they didn't take it properly and under the correct medical supervision. Any drug that affects the brain needs to be treated with caution, so if people are in any doubt they should probably consider one of the NRT alternatives."
He added, "there may be risks associated with taking Zyban but there are much greater risks associated with continuing to smoke. It's up to individuals to weigh these up."
A report in the New England Journal of Medicine found that "almost one in three people treated with Zyban were not smoking after one year, compared to 16.4 percent of people using a nicotine patch. Zyban was thereby found to be almost twice as effective as a nicotine patch in helping people to quit smoking."
Is Zyban safe?
- There have been 7,472 reports of suspected adverse reactions to Zyban, of which 46 have been fatal
- At least 513,000 patients are estimated to have used Zyban in the UK
- The manufacturers recommend that Zyban is not taken by those with certain conditions such as epilepsy, a history of seizures or those who have had eating disorders
- The Committee on the Safety of Medicines considers that the reports received are in line with the known safety profile of Zyban, which is fully reflected in the product information for health professionals and patients
- Zyban is not recommended for women who are pregnant or breast-feeding
- According to GlaxoSmithKline "there is no evidence of an increased risk of death associated with the use of [Zyban]". (As at 8 April 2002)
What are the side effects?
As with all medicines, there are risks of adverse effects:
- The most common side effects include dry mouth and difficulty sleeping
- There is also a risk of seizure, which is increased in certain patients
- Other possible side effects could include: nausea, dizziness, headaches, cold or influenza-type symptoms, palpitations, stomach upset, chest pains, anxiety and irritability, sore throat and an unpleasant taste in the mouth.
How does Zyban work?
- Zyban comes in tablet form and costs the charge of an NHS prescription
- Zyban works in the brain help break the addiction to nicotine by modifying two neurotransmitters involved in nicotine addiction and withdrawal
- It is claimed that Zyban reduces your urge to smoke and helps to alleviate the withdrawal symptoms you may experience when stopping smoking.
- Unlike nicotine patches, it does not substitute one form of nicotine for another
- The drug has been shown to reduce cravings for cigarettes or the urge to smoke, and the withdrawal symptoms of stopping smoking
- Zyban is taken for a two-month treatment course, and works best if the patient has access to a support programme, such as the 'Right Time Programmè, operated by the drug's manufacturers GlaxoSmithKline which provides useful advice on coping with withdrawal, maintaining motivation, action plans and telephone support
- According to the CSM, Zyban has been shown to increase the chances of stopping smoking compared with other methods.