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US drug labels lacking

Drug labels in the US often are not explicit about the severity of side effects and the true efficacy of the product, according to NEJM report

Medicines labels in the US often do not carry information showing the severity of side effects or details of the efficacy of the drug, according to a report in the New England Journal of Medicine (NEJM).

Drs Lisa Schwartz and Steven Woloshin of the Dartmouth Institute for Health and Clinical Practice in Hanover, New Hampshire, stated that the resulting document accompanying the product makes the medicine appear far safer and more effective than it really is. "Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles," they said.

The authors cite Sepracor's four-year-old insomnia treatment, Lunesta, for which a 2007 advertising campaign cost $750,000 a day, as an example of inaccurate labelling.

According to Schwartz and Woloshin the label says that Lunesta was superior to a placebo. However, data submitted to the FDA reveal that in the largest and longest study "Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvements in next-day alertness or functioning". 

Schwartz and Woloshin went on to say that often it is data on 'harms' that gets lost on labels.

In 2008, the FDA's Risk Advisory Committee voted unanimously to endorse a format for improving labelling developed by Woloshin and his colleagues. The committee is due to meet Woloshin and his colleagues to discuss the issue in November.

22nd October 2009

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