Wyeth defends Effexor XR safety profile

Wyeth has defended the safety profile of its depression drug Effexor XR (known in the UK as Efexor XL) after reports in the US suggested that some users may have developed homicidal thoughts while using the product.

The company said that although “homicidal ideation” was listed as an observed side-effect in the label for Effexor XR, no causal link has been established between the drug and homicidal thoughts.

Wyeth asserted that it has always acted responsibly and in accordance with regulatory requirements in disclosing safety information.

Dr Joseph Camardo, senior vice-president of global medical affairs at Wyeth, stated: “Depression is a serious, complex disease that can be difficult to treat, and patients with depression can have other serious co-morbid psychiatric illnesses.

“Homicidal thoughts may occur in patients with psychiatric conditions whether or not a patient is being treated with psychotropic medications.”

“It is unfortunate that unsubstantiated and irresponsible allegations have been made that may create undue concern and confusion on the part of patients who benefit from treatment with Effexor XR,” he concluded.

Wyeth first introduced the drug in 1993. In May, Wyeth announced that patients taking Effexor XR over two years were “significantly” more likely to avoid bouts of depression than patients taking the placebo.

In the second half of the study, researchers found that eight per cent of Effexor XR patients relapsed into depression, compared with 44.8 per cent using the placebo.

Wyeth said the trial results could encourage doctors to raise their expectations of treatment in preventing new episodes of depression.

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