Time to quit but watch for side effects
POPULAR anti-smoking drugs could be forced to carry strong warnings about the risks they pose to mental health, including the risk of suicidal thoughts.
Statistics from Australia’s drug regulator, the Therapeutic Goods Administration, show six suicides and another 2500 adverse effects have been linked to Champix and Zyban in recent years.
An administration spokeswoman said although Champix’s product information was updated to include warnings about psychological side effects last year, it planned to strengthen information given to consumers about the drugs after US authorities last week ordered the manufacturers, Pfizer and GlaxoSmithKline, to place bold warnings inside the packets.
The US warnings will highlight the “risk of serious mental health events” when taking the drugs, including behavioural changes, depression, hostility and suicidal thoughts.
“The US FDA has decided to strengthen the warnings for both products in light of further reports of problems with use. The TGA is reviewing the new information and will strengthen the consumer medicine information and the product information for both products,” the spokeswoman said.
By last March the administration had received 544 and 1983 reports of patients suspected of experiencing adverse events possibly related to Champix and Zyban respectively.
“These include three reports of suicide in each case, but a causal link to the use of Champix or Zyban is uncertain,” the spokeswoman said.
In the past financial year, 454,475 Australians used Champix and nearly 25,000 people received Zyban or a similar equivalent through the pharmaceutical benefits scheme.
The director of the US Food and Drug Administration’s Centre for Drug Evaluation and Research, Janet Woodcock, said doctors should monitor their patients for any unusual mood or behavioural changes after the medicines were taken.
“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” she said last week. She stressed that the products were “effective aids in helping people quit” smoking.
A spokeswoman for GlaxoSmithKline said Zyban’s product information included a statement about mental health.
“Doctors should consider this in their prescribing decisions. The potential risks of prescribing this type of treatment should be weighed against the potential benefits of giving up smoking in each patient,” she said.
A spokeswoman for Pfizer said the company was working closely with the administration to keep the product’s information for health professionals and consumers up to date.
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