Yet another problem with Champix (cardiovascular)

Reports today indicate slightly raised risks of cardiovascular problems. A recent trial of patients with cardiovascular disease showed patients taking Champix were slightly more likely to experience heart problems than those taking a placebo.

Written warnings accompanying the drug will warn patients of this risk and Pfizer will be required by the FDA to carry out further studies in order to establish the risk more clearly.

The risk is said to be 'small' – that will surprise no one! What beats me is why anyone will take it for such a limited outcome:

An independent randomized trial of 700 smokers with cardiovascular disease who were treated with Chantix or a placebo showed that Chantix was effective in helping patients quit smoking for as long as one year. [emphasis added]

Other problems are by now well documented:

Chantix has been associated with agitation, depression and suicidal thoughts, and, in clinical trials, linked with nightmares. Psychiatric symptoms have occurred in people without a history of mental illness and have worsened in people who already had mental illness. [emphasis added]

 To this, we can add an apparent cover up of adverse incidents involving Champix.

Federal Food and Drug Administration officials acknowledged that they asked Pfizer to resubmit thousands of records after realizing that the company was sending required reports in an inappropriate format that could not be added to the agency’s Adverse Events Reporting System, or AERS.

The French Health Minister has recently delisted Champix as a publicly funded drug. I put the point to the local NHS trust in Scotland, putting the point that the French Minister had banned the drug and requesting its withdrawal by NHS Lothian. Their reply follows:

The Scottish Government does not advise upon the licensing and safety of medicines since this is not a devolved power for the Scottish Government. As such, they are would not be in a position to withdraw this medicine from use across Scotland . The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK organisation responsible for the licensing of medicines and monitoring of the safety of these medicines. Information on this organisation and its activities to ensure public safety with medicines can be found at http://www.mhra.gov.uk/index.htm 

The MHRA has had varenicline under intensive surveillance for the last couple of years to ensure that the benefit to patients continues to outweigh any potential risks. They work in collaboration with the international drug safety monitoring network to ensure safety of medicines. A copy of an article writtten for their publication the Drug Safety Update on this can be seen at http://www.mhra.gov.uk/Safetyinformatio ... /CON087722 . They encourage all healthcare professionals and patients to be vigilant in reporting any suspected side effects with this medicine. Patients and healthcare professionals can report any suspected reactions for medicines at http://yellowcard.mhra.gov.uk/

At present there has not been any indication given by the MHRA that varenicline should not be used; but continued monitoring of safety is ongoing. Therefore it remains licensed for use within the UK . Prescribers have been made aware of the risk; and should be taking this into consideration when deciding if the potential benefit to the patient before prescribing for a patient. There is no move currently to discontinue use of the medicine in appropriate patients that are likely to recive benefit. If, however, there is additional warnings issued from the MHRA of safety concerns (or indeed recommend withdrawal from use), then NHS Lothian and all other Health Boards across Scotland would then comply.

I hope this information is of use to you.

Yours sincerely

Melinda Cuthbert

Lead Pharmacist Lothian Medicines Information Service/Yellow Card Centre Scotland, Pharmacy Department, Royal Infirmary of Edinburgh, Edinburgh EH16 4SA

Clearly MHRA needs to be notified of public concern. It is extraordinary that a drug with such effects is recommended, subsidised, to the general public, especially people with a psychiatric history, when even those without such a history are disturbed by it.  ASH Scotland's most recent update (scroll down this link) on Champix and mental health says:

Clinical trials during drug development excluded patients with active psychiatric illnesses leaving the risks associated with varenicline use in this patient population unknown. A review of the evidence in Expert Opinion on Drug Safety has concluded that although the risk of potential neuropsychiatric events is evident through voluntary reporting systems and reported cases in the literature, multiple studies and case reports support the use of varenicline in the mental health population. 

As often, I take a diametrically opposing view.

Start Champix earlier in quit attempt and it might work, says Pfizer study!

Pfizer's new study claiming that starting earlier on Champix would improve its effectiveness couldn't come at a better time. This drug has maimed countless lives, and is the subject of a black box warning. Peter Hajek of the UK Centre for Tobacco Control Studies (no competing interests of course) and colleagues 'compare the effect to making food look unappealing. "The level of hunger pangs may be the same, but it is easier to resist a food that has become less tempting," they note.'

This is a poor comparison. Messing with someone's brain doesn't resemble disfiguring somebody's dinner. 

The people at the UK Centre for Tobacco Control Studies know how ineffective many quit attempts are.  Another member, Tim Coleman expressed this view in November:

Currently stop smoking services are evaluated on the percentage of 4-week quitters, but around three-quarters relapse after this date. 

His solution was to attempt to get funding for people to take smoking cessation drugs (NRT) in the longer term as a kind of damage limitation exercise. A similar assessment comes from the Tobacco Control blog, discussing Turkey's new anti-smoking facilities:

It’s worth remembering that, if the Turkish experience mirrors international evidence, every hotline call represents several other smokers who have decided to quit on their own. Even in countries with excellent, and often free, quit resources, more than 80% of smokers quit cold turkey (pun intended!) on their own.

An editorial discussing this study comments: 

One in five Americans smokes [...] and only between 4 and 7 percent of those who try to stop succeed. 

 These people know what a poor success rate smoking cessation drugs have. Yet huge amounts of money are spent promoting them, even on solutions like Champix which occasionally spell disaster for those taking it and their families.  

ASH Scotland is on a crusade to persuade the managers of Scottish mental health facilities to remove smoking rooms. Their next event will 'explore the new implementation guidelines' published by the Scottish government. No doubt they will be urged to ensure that smoking cessation meds are always available to patients who are forced into a no-smoking regime at a catastrophic time in their lives. Stopping people from smoking trumps every other consideration.