The Food and Drug Administration in the US has added to the label of varenicline, (Champix), new safety information and the European Medicines Agency, the European drugs regulator, has said that the benefits of Champix outweigh the risks, thus quashing recent concerns regarding the safety and efficacy of this smoking cessation product.

Earlier in the year, the Food and Drug Administration published a warning about the drug after a meta-analysis was carried out by researchers at the John Hopkins School of Medicine in Baltimore and subsequently published in the Canadian Medical Association Journal.

The European Medicines Agency’s Committee for Medicinal Products for Human Use, stated that the meta-analysis carried out and the evidence gathered was not sufficient to put the safety and efficacy of the drug into question as it only reported a small number of adverse events among those who took the Champix and that among those who were taking the placebo, there were much higher dropout rates than among those on the smoking cessation product.

However, the Food and Drug Administration have also said that varenicline is successful when used by patients who suffer from cardiovascular illness who want to quit smoking but that it is also associated with a small increased risk of cardiovascular events in those patients.

The European Medicines Agency tell doctors that the risk/benefit profile of varenicline is positive still and that the meta-analysis carried out in Baltimore included too many limitations, especially the fact that there were an extremely low number of events recorded. However, the agency requested that the manufacturer submit more information on cardiovascular outcomes that might be added to the information accompanying the product.

Pfizer’s smoking cessation product, Chantix (Champix) will be relabelled after the FDA’s (Food and Drug Administration) latest recommendation. The drug has been associated with heart problems in those who suffer from cardiovascular disease.

The FDA is changing the label in order to highlight the danger of the drugs active ingredient, Varenicline Tartrate, and its association with increased risk of heart problems after results of a new clinical trial were announced. It is important to stress however that the drug was found to increase risk only in those who had a pre-existing cardiovascular condition.

The FDA make sure that Chantix carries a black box warning which is the most serious label used by the regulators. After the news regarding such side effects and also an association with depression and suicidal ideation and erratic behaviour, the FDA decided that all of these side effects needed to be included on the warning label. Side effects relating to depression, reports of feelings of aggression and suicidal behaviour have not been found in clinical trials to be of a significant enough number to suggest the drug is dangerous but nevertheless, they must be listed as possible side effects.

An independent trial took place where 700 smokers, who already had cardiovascular disease, were observed. They were treated with either the drug in question or a placebo. The results show that the drug was successful in helping patients to stop smoking. Those who took the drug were also more inclined to suffer a cardiovascular problem than those who were taking the placebo.

The FDA will require Pfizer to carry out a large-scale trial in order to assess the risk associated and would later discuss the outcomes with the manufacturer. The risk-benefit profile of this drug is under scrutiny now but perhaps this will mean that it is merely contraindicated for those who suffer from cardiovascular illness.

There is a lot of discussion about the electronic cigarette industry at the moment; cartridges of nicotine and some other chemicals with no tobacco that have been marketed as replacements for cigars and cigarettes. The Food and Drug Administration (FDA) has warned the companies behind such devices that the products must be regulated and submitted for FDA approval. This has sparked fear of withdrawal of the products among the e- cigarette companies however the FDA is only interested in examining the safety and efficacy of this alternative smoking cessation product.

Upon inhalation, the liquid in the e-cigarette is vaporized by a battery and water vapour creates the illusion of smoke. The FDA seeks regulation of this product as it is a device used to carry a drug into the body and if a product can be labelled as a drug or a drug delivery device, it must be approved. In addition, they want to ensure the manufacturing of these cigarettes is carried out safely.

Five companies have been warned that they have 15 days to respond to the FDA. So far the companies have argued that it is unnecessary to be preapproved since they are replacing tobacco products and so should be treated in the same way that the tobacco products are. They are marketed as both alternatives to cigarettes and an aid to help one stop smoking. The nicotine hit from these cigarettes is 10 times faster than that of Nicorette gum or patches.

Champix on the other hand is a regulated prescription drug with no nicotine and it serves to bind to nicotine receptors, thus decreasing withdrawal symptoms of quitters. E-cigarettes are being marketed with a choice of flavours, which may attract children to use the product. Those who are not addicted to cigarettes could begin a new addiction. In the case of Champix however, it may only be prescribed to those who have a smoking addiction and removes the cravings whereas the e- cigarettes can perpetuate the feelings of addiction. Regulated smoking cessation aids are safer to use and Champix has a proven success rate.

The NHS has released its latest figures on smoking trends. Apparently 373,964 people in the UK quit smoking in the last year. This is an 11% increase in quitters on the previous year. The British Heart Foundation has reported that the percentage of adult smokers remains high at 21% despite a consistently improving trend since the smoking ban of 2007. The NHS had put £10 million more into its anti-smoking campaigns over this last year than it contributed in the previous year. Altogether, the Government spent £84 million on these services. It is estimated that smoking costs the NHS £2.7 billion annually.

The figures convey that the most successful method used to stop smoking is Champix. 60% of its users were successful in quitting according to the report – this is significantly in excess of the percentage of successful quitters from the clinical trials relating to Champix. Only 23% of smokers choose medication in the place of nicotine gum and patches but perhaps they will revaluate their cessation methods after looking at these figures!

Friends of the troubled actress Lindsay Lohan have said they are very concerned as to how she will cope with her cigarette addiction during the 90-day stay in jail she is facing.

Lohan was told by Judge Marsha Revel that she needed to serve the jail term after a string of violations of the terms of an earlier sentence following a drink-driving incident in 2007. She has been told she needs to surrender herself to the women-only jail on the 20^th July.

The prison has a strict no-smoking policy and adopts a zero-tolerance approach to those breaking the rule. However friends have told gossip site TMZ that Lohan smokes at least two packets of cigerettes a day and for years hasn’t gone a day without smoking.

The source described her habit as a ‘serious condition’ and said they were ‘honestly scared’ for the star.

Friends have reportedly been urging her to give up now, so she can get acclimatised to the prospect of three months without smoking.

While in a similar case of extreme addiction to nicotine, a medication like Champix, Lohan is reportedly struggling with a severe dependence on a variety of other prescription medications, so medication probably won’t be an option to help her cope with her nicotine cravings.

She has also been told to attend  a rehab program as part of her sentence – hopefully this will help her change her lifestyle and get healthy!

The American Food and Drugs Agency, which regulates drug use in the U.S, has decided that there needs to be a label change for the smoking-cessation medication Champix. The change in the wording of the label will reflect concerns that the treatment may be linked to depression.