THE safety of the anti-smoking drug, Champix, is being closely monitored by the Irish Medicines Board (IMB), as it emerged that the drug is one of the most commonly complained about drugs in the United States.
The US Food and Drug Administration has confirmed that Champix (called Chantix in the US) and Heparin, the blood-thinning tablet, account for a large share of reported negative drug reaction and deaths. Heparin has been under the microscope after tainted batches of the drug were imported from China.
Champix, which had the most reports of any medication, works directly in a smoker’s brain to ease withdrawal symptoms. It also blocks the pleasurable effects of nicotine, if the patient is tempted to light up again. Earlier this year, the FDA warned that Champix may be linked to psychiatric problems, including suicidal behaviour and vivid dreams. Pfizer said it stands by the tablet and the volume of reports might be linked to publicity about side effects.
The FDA report highlighted 15 cases of Champix patients who appeared to have been involved in traffic accidents, and 52 additional cases involving blackouts or loss of consciousness. The FDA is taking a second look at the Champix warnings.
The agency received 1,001 reports of serious injuries linked to Champix, more than for the 10 best-selling brand name drugs combined.
A spokeswoman for the Irish Medicines Board said Champix is being monitored by the Irish Medicines Board, in conjunction with its EU counterparts.
“Champix was approved for use throughout the EU (with Denmark and the Netherlands acting as the lead Member States for assessment of the product), through the European centralised procedure which means that any regulatory action, including changes to the product information, must be made at EU level.
“Further changes were made to the product information in April 2008 to strengthen warnings to doctors and patients that depression has been reported in patients who are trying to stop smoking using Champix. The symptoms of this depression may include suicidal ideation and suicide attempt,” she said.
The FDA defines serious drug reactions as ones that cause hospitalisation, require medical intervention, or place a life in jeopardy.
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