Patients in dark over drug effects

PRODUCERS of one the most common anti-depressant drugs on the market are again embroiled in controversy over whether patients have been informed of its full effects.

The Irish Medicines Board, the regulatory authority for drugs, has told GlaxoSmithKline to change the patient information it gives out with Seroxat.

The leaflet claims that the drug works by returning serotonin levels to normal. However, doctors say the link between depression and serotonin levels is unproved.

This follows complaints by Limerick-based family doctor and psychotherapist Terry Lynch, who highlighted the wording of the leaflet.

It follows a storm of controversy last October when pharmacists were instructed to warn patients taking the anti-depressant that the information leaflet accompanying the drug omitted a reference to self-harm and suicide.

Dr Lynch said claims that the drug reduced serotonin levels could not be proven because patients do not have this measured while taking Seroxat.

“The bottom line is that we doctors have no idea whether the patients we treat with Seroxat have a normal, low or raised serotonin level at any stage of the entire process of diagnosis and treatment,” he said.

“We have absolutely no idea how our patients’ serotonin levels are responding to the treatment on an ongoing basis. In 20 years as a medical doctor, I have never, ever heard of a patient anywhere having their serotonin levels checked.”

Dr Lynch said these claims occur with some regularity in medicine, and are a central theme in his book Beyond Prozac, which explores the healing of mental illness without drugs.

The Irish Medicines Board has accepted that the claims in the leaflet accompanying the drug “are not consistent with the scientific literature”.

It has asked GlaxoSmithKline to review its literature accordingly. Attempts to contact the firm yesterday were unsuccessful.

Seroxat has been on the market for 10 years but it is not clear how long claims that it reduces serotonin levels have accompanied the product.

Dr Lynch says it has been on the product since at least 1998 which raised the question of whether tens of thousands of patients were fully informed of the drug’s effects.

Last year, the IMB ordered the company to recall the product from wholesalers and issue a clarification letter and the revised patient information leaflet to pharmacists and doctors

Concerns were raised by callers to RTÉ’s Liveline show this week, some of whom spoke of attempts at self-mutilation while on the drug. A number of callers also claimed relatives had committed suicide while taking the drug.