FDA to review Champix side effects

The US Food and Drugs Administration (FDA) is to review the safety of smoking cessation drug varenicline (Champix) following reports of suicidal, aggressive and erratic behaviour.

Some of these reports have come from the manufacturer of the drug, Pfizer, and others from the media and the internet, the regulator said.

There have also been reports of drowsiness, to the point of affecting the ability to drive, associated with the use of Champix.

A Pfizer UK spokesperson said that there is no scientific evidence establishing a causal relationship between varenicline and the post-marketing report events, and the role of Champix, marketed as Chantix in the US, is still unknown.

The agency has now asked Pfizer for any additional cases of side-effects that it is aware of and is currently reviewing the data.

The FDA recommends that GPs monitor patients taking Champix for behaviour and mood changes.

The Pfizer spokesperson said it was too early to speculate on any potential impact the review would have on the marketing of Champix in the UK but said the pharmaceutical manufacturer was in close contact with the European Medicines Evaluation Agency (EMEA) regarding the FDA communication.

'Pfizer is assessing the potential impact on the European product information and will continue to collaborate with the EMEA on any further developments,' said Pfizer in a statement.

Champix was licensed by the European Medicines Agency (EMA) in September 2006 and was made available on the NHS.

sanjay.tanday@haymarket.com

Comment below and tell us what you think

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register

Already registered?

Sign in

Follow Us:

Just published

Most children could be removed from shielded patient list, deputy CMO suggests

Most children could be removed from shielded patient list, deputy CMO suggests

Most children could be removed from the shielded patient list in a future wave of...

GPs can provide some care for shielded patients in clinical settings, NHS England confirms

GPs can provide some care for shielded patients in clinical settings, NHS England confirms

GPs can provide care to shielded patients in 'infection-controlled clinical settings'...

How digital assistants can help patients manage their health and wellbeing

How digital assistants can help patients manage their health and wellbeing

A project in Staffordshire has shown how practices can make use of digital technology...

Coronavirus: Key guidance GPs need to know about COVID-19

Coronavirus: Key guidance GPs need to know about COVID-19

GPonline provides an overview of the key guidance relating to coronavirus, including...

Fair death-in-service deal for locums vital before second COVID-19 wave, warns BMA

Fair death-in-service deal for locums vital before second COVID-19 wave, warns BMA

The government must do ‘the right thing’ and secure adequate death-in-service benefits...

GP workload fears over antibody testing rollout for 'no clinical benefit'

GP workload fears over antibody testing rollout for 'no clinical benefit'

GP practices are being contacted by patients asking for antibody tests as the government...