Healthy Skepticism Library item: 10341

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Publication type: news

Cresswell A.
Alert over sleep drug ignored
The Australian 2007 Jun 2
http://www.theaustralian.news.com.au/story/0,20867,21834708-23289,00.html

Full text:

THE drug watchdog is again under fire after it admitted dropping a recommendation from its own experts that a “black box” warning be slapped on the controversial sleeping pill Stilnox, despite a flood of complaints over its sometimes bizarre and even potentially deadly effects.
Stilnox — known generically as zolpidem — has been linked to hundreds of sleep-walking incidents in which patients have been found cooking, eating and even driving while asleep. One man is thought to have fallen from a 12th-floor balcony after taking the drug.

About 250,000 Australians take Stilnox every year.

Although warnings on the drug were strengthened at the behest of the Therapeutic Goods Administration in April, the TGA has admitted its own advisory committees had recommended a black box warning be placed on the drug.

A black box warning is added to product information sheets and is an eye-catching signal to doctors and others that there are safety or other concerns. It is regarded as the strongest measure regulators can take, short of forcing the drug to be withdrawn.

An investigation by the Nine Network’s Sunday program has turned up more disturbing incidents, including one where a woman took Stilnox and later tried to stab herself in the stomach. The program also interviewed the chairman of a TGA advisory body, the Adverse Drug Reactions Advisory Committee, who conceded a black box warning had been suggested. That recommendation went to its parent committee, the Australian Drug Evaluation Committee, but went no further.

There have been more than 600 reports of adverse events from Stilnox to the Adverse Medicines Events Line. Its manager, clinical pharmacist Geraldine Moses, said the warnings added in April were inadequate and called for Stilnox to be put under the same restrictions as the so-called “date-rape” drug Rohypnol, “so it has to be kept in a safe”.

A TGA spokeswoman said it was “absolute nonsense to suggest that warnings about the side-effects of Stilnox were watered down to appease the drug company” and it was the TGA that publicised the sleep-walking episodes in the first place.

“ADEC suggested a black box may be necessary to strengthen warnings, but these would only appear in the product information (PI),” she said.

“The outcome achieved by the TGA with the company was in fact a much more comprehensive approach.”

Changes were made both to PI and information given to patients, and warnings not to use Stilnox while or after drinking alcohol were placed on the label, the spokeswoman said.