Firm agrees to alter leaflet to patients after complaints

Sarah Boseley, health editor
Saturday May 3, 2003
The Guardian

The drug company which makes Seroxat, the antidepressant which thousands of people say they cannot give up because of severe withdrawal effects, is to drop the claim on its patient leaflet saying the drug is not addictive.

The admission of a change of policy from GlaxoSmithKline, Britain's biggest pharmaceutical company, comes in a BBC Panorama programme to be shown on May 11.

Emails from the Edge examines the big response from Seroxat users to its first investigation, in October, of its withdrawal problems.

Seroxat is a commonly prescribed antidepressant of the SSRI (selective serotonin re-uptake inhibitor) class, to which Prozac also belongs.

Many people say it has changed their lives by lifting them out of depression, but some experience distressing side-effects when they try to reduce the dose and stop taking it. These effects are said to include sensations comparable to electric shock.

Last July the Guardian revealed that Seroxat topped the league table for complaints of side-effects made by doctors to the government's committee on the safety of medicines under the yellow card scheme. A total of 1,281 complaints were filed - more than the combined amount for the rest of the top 20 most cited drugs.

The watchdog group Social Audit complained at the time about the wording on the Seroxat patient information leaflet. It states that "these tablets are not addictive", and that withdrawal problems "are not common and not a sign of addiction".

Alastair Benbow, head of European clinical psychiatry at GSK, says in the film that the wording was poorly understood by patients. Yesterday he told the Guardian that he accepted that the drug, like other medicines, did cause physiological changes. "It is absolutely right, some people have symptoms and for some those are very troubling."

But GSK is unlikely to head off the mounting criticism because it intends to keep the advice issued in a separate information sheet to doctors which says the drug does not cause dependence.

David Healy, director of the North Wales department of psychological medicine, has long argued that the company should change its advice to doctors.

"If there is withdrawal, then there is physical dependence. There will be some people who will never be able to halt this drug, there will be some for whom halting will not be awfully difficult and some for whom it is a real issue." The SSRIs were not like opiates such as heroin which causes drug depmcency as opposed to physical dependency, he said. They were more comparable to the benzodiazepines such as Valium, which is now prescribed only with great caution because of withdrawal problems.

Charles Medawar, of Social Audit, was not impressed by GSK's move. "My feeling is that the changes GSK proposes could and should have been made at least five years ago and will not tell patients anything they don't know. They are glossing over the reality. This is far too little, too late."

Sarah Venn, of the Seroxat users group which has 4,000 members, said: "We are pleased to have this news but it doesn't address the information provided to doctors. It doesn't go anywhere near helping patients who are on this drug and can't get off it."

Some patients complain of doctors lacking sympathy when told about the side-effects.

But Dr Benbow said GSK's "feedback" showed doctors did understand what was meant and he could see no reason to spell out the difference between "physical dependency" and "drug dependency".

"I think we would start to get into difficulties of definition." He said the wording of the doctors' leaflet should only be changed "if we think there is a clear lack of understanding [by] the doctors," he added.