The medicines watchdog has revealed that reports of suicidal feelings among patients taking a stop-smoking drug are being “monitored closely”.
The Medicines and Healthcare products Regulatory Agency (MHRA) is looking at evidence after the US Food and Drug Administration (FDA) launched an evaluation of Champix (called Chantix in the US).
The drug, which is also known as varenicline, is a prescription-only medicine which was launched in the UK last December. Since than between 15,000 and 20,000 people in the UK have taken it.
However, the MHRA said it had received 839 reports of suspected adverse drug reactions in relation to Champix as of September 26.
Of these, 46 related to depression associated with the use of the drug, mostly in patients with a previous psychiatric history.
There have been another 16 reports of suicidal thoughts but no reports of actual suicides.
A statement from Pfizer, which manufactures the drug, said: “Pfizer is 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.
“If patients are concerned about any aspect of their medication, they should consult their doctor.”
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