Danger signs for smoking drugs

POPULAR anti-smoking drugs could soon be forced to carry strong warnings about the risks they pose to mental health, including suicidal thoughts.

New 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.

A TGA spokeswoman said although Champix’s product information was updated last year to include warnings about psychological side effects, it planned to strengthen information given to consumers about the drugs after US authorities last week ordered manufacturers Pfizer and GlaxoSmithKline to put bold warnings inside the packets.

The US warnings will highlight the “risk of serious mental health events” when taking the drugs, including behaviour changes, depression, hostility and suicidal thoughts.

As of March, the TGA had received 544 reports of patients suspected of experiencing adverse events possibly related to Champix and 1983 relating to Zyban, including three suicides.

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.

A spokeswoman for GlaxoSmithKline said Zyban’s product information included a statement about mental health.

“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.

source: http://www.theage.com.au

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