Drug giant faces huge law suit
'Prozac miracle' could end in disaster
Sarah Boseley, Health Editor
Thursday September 6, 2001
The Guardian
A major lawsuit has been launched against the British pharmaceutical giant GlaxoSmithKline on behalf of a group of people who say they became chronically addicted to an antidepressant drug in the same class as Prozac.
The case, which has been filed in California, is the first ever to claim damages for addiction against one of the drug companies that have made billions from SSRIs (selective serotonin reuptake inhibitors) - the class of drug of which Prozac is the best known - and which were hailed as "wonderdrugs" when they first hit the market in the 1980s.
The drug is known as Seroxat in Britain and Paxil in the US. There are 35 people in the class action at the moment - from a website designer to a bank fraud investigator and a senior airforce officer - but many more are expected to join it. All were prescribed Paxil/Seroxat for mild depression or anxiety and none was told they might become hooked.
When they tried to stop taking it, they suffered violent and disturbing symptoms, including jolting pains in the head, vertigo, loss of coordination, abdominal discomfort, flu symptoms, agitation and confusion.
The lawyers involved say the action could be as big as tobacco litigation. Since news of the SSRI action emerged in the US a week ago, over 1,500 people have called the offices of the Los Angeles law firm involved telling of similar experiences. Some have been seriously distressed.
Many say their problems were wrongly ascribed to other things by doctors who are unaware of the potential for addiction of the drug. One had a pacemaker fitted, which has since been removed, some were given electric shock therapy and some thought they had brain tumours.
"We have had a heck of a response," said Skip Murgatroyd, the attorney from Baum, Hedlund, Aristei, Guilford and Schiavo, leading the case. "It is unprecedented for us. Some of these people are in such bad shape that they can't get off the drug without professional help. Some have been on it for 10 years.
"We're going to ask GlaxoSmithKline to set up centres all over the US to help them." Hundreds of thousands are believed to be suffering.
Concern over the potential for addiction of the SSRIs has been growing in recent years. Charles Medawar of the UK watchdog organisation Social Audit said: "I would think that the scale of the problem in the UK is comparable and I can't see a lawsuit not happening here. I think people are extremely angry. It was obvious this was going to happen two to three years ago, but the Medicines Control Agency - the regulators - have done nothing to forestall it."
The lawsuit alleges that the manufacturer, GlaxoSmithKline, has deliberately failed to warn doctors and patients that Paxil/Seroxat can cause severe withdrawal reactions. It says that the company has wrongly claimed the bad reactions are caused by a relapse into depression when people stop the drug, yet some people experience symptoms when they stop taking the drug which they did not have before they first took it.
The US lawyers allege that all the SSRI class of antidepressants have the potential to cause withdrawal reactions when people try to stop taking them, but that Paxil/Seroxat is the worst. The drug, which has the generic name of paroxetine, is at the top of a league table produced by the World Health Organisation which records complaints from 60 countries of bad reactions to medicines.
Venlafaxine, which has the brand name Effexor, is second. A British man, Steve Whiting, secured legal aid to bring a case over addiction to Effexor in this country against its manufacturer, Wyeth-Ayerst. Prozac (fluoxetine) is in seventh place.
One of the reasons that Paxil/Seroxat causes so many problems, said Mr Medawar, is that it is as widely used - if not more widely - than Prozac. It is prescribed not just for mild depression but for a range of anxiety and mood disorders, such as obsessive compulsive disorder and "social anxiety disorder" - for people who feel panicky at the thought of mixing at parties.
But crucially, he said, the problems show up when people try to stop taking Paxil/Seroxat because it has a shorter half-life than most of the other SSRIs. That means it clears the body faster and so it is more obvious that fatigue and pains are related to quitting the drug. With SSRIs that linger in the system for longer, by the time the symptoms appear it may seem that depression has set in again - and so the doctor's answer is another SSRI prescription.
GlaxoSmithKline insists there is no problem with its drug. "There is absolutely no reliable scientific evidence that Paxil is addictive or leads to dependence," said a spokesman.
He added: "As far as we're concerned, all of the regulatory bodies are quite happy with the product."
But Social Audit, which has monitored antidepressant drugs for decades, sees history repeating itself. Morphine was used for years to treat opium addiction. Barbiturates, found to be horribly addictive, were replaced by the benzodiazepines - such as Librium, Valium and Mogadon - which were liberally prescribed as safer and non-addictive. Then came Ativan, which like Paxil/Seroxat had a short half-life, and the symptoms of benzodiazepine dependence became clear.
The SSRIs have largely taken their place, but according to Mr Medawar, little has changed.
---
article: http://www.guardian.co.uk/international/story/0,3604,547560,00.html
'Prozac miracle' could end in disaster
Sarah Boseley, Health Editor
Thursday September 6, 2001
The Guardian
A major lawsuit has been launched against the British pharmaceutical giant GlaxoSmithKline on behalf of a group of people who say they became chronically addicted to an antidepressant drug in the same class as Prozac.
The case, which has been filed in California, is the first ever to claim damages for addiction against one of the drug companies that have made billions from SSRIs (selective serotonin reuptake inhibitors) - the class of drug of which Prozac is the best known - and which were hailed as "wonderdrugs" when they first hit the market in the 1980s.
The drug is known as Seroxat in Britain and Paxil in the US. There are 35 people in the class action at the moment - from a website designer to a bank fraud investigator and a senior airforce officer - but many more are expected to join it. All were prescribed Paxil/Seroxat for mild depression or anxiety and none was told they might become hooked.
When they tried to stop taking it, they suffered violent and disturbing symptoms, including jolting pains in the head, vertigo, loss of coordination, abdominal discomfort, flu symptoms, agitation and confusion.
The lawyers involved say the action could be as big as tobacco litigation. Since news of the SSRI action emerged in the US a week ago, over 1,500 people have called the offices of the Los Angeles law firm involved telling of similar experiences. Some have been seriously distressed.
Many say their problems were wrongly ascribed to other things by doctors who are unaware of the potential for addiction of the drug. One had a pacemaker fitted, which has since been removed, some were given electric shock therapy and some thought they had brain tumours.
"We have had a heck of a response," said Skip Murgatroyd, the attorney from Baum, Hedlund, Aristei, Guilford and Schiavo, leading the case. "It is unprecedented for us. Some of these people are in such bad shape that they can't get off the drug without professional help. Some have been on it for 10 years.
"We're going to ask GlaxoSmithKline to set up centres all over the US to help them." Hundreds of thousands are believed to be suffering.
Concern over the potential for addiction of the SSRIs has been growing in recent years. Charles Medawar of the UK watchdog organisation Social Audit said: "I would think that the scale of the problem in the UK is comparable and I can't see a lawsuit not happening here. I think people are extremely angry. It was obvious this was going to happen two to three years ago, but the Medicines Control Agency - the regulators - have done nothing to forestall it."
The lawsuit alleges that the manufacturer, GlaxoSmithKline, has deliberately failed to warn doctors and patients that Paxil/Seroxat can cause severe withdrawal reactions. It says that the company has wrongly claimed the bad reactions are caused by a relapse into depression when people stop the drug, yet some people experience symptoms when they stop taking the drug which they did not have before they first took it.
The US lawyers allege that all the SSRI class of antidepressants have the potential to cause withdrawal reactions when people try to stop taking them, but that Paxil/Seroxat is the worst. The drug, which has the generic name of paroxetine, is at the top of a league table produced by the World Health Organisation which records complaints from 60 countries of bad reactions to medicines.
Venlafaxine, which has the brand name Effexor, is second. A British man, Steve Whiting, secured legal aid to bring a case over addiction to Effexor in this country against its manufacturer, Wyeth-Ayerst. Prozac (fluoxetine) is in seventh place.
One of the reasons that Paxil/Seroxat causes so many problems, said Mr Medawar, is that it is as widely used - if not more widely - than Prozac. It is prescribed not just for mild depression but for a range of anxiety and mood disorders, such as obsessive compulsive disorder and "social anxiety disorder" - for people who feel panicky at the thought of mixing at parties.
But crucially, he said, the problems show up when people try to stop taking Paxil/Seroxat because it has a shorter half-life than most of the other SSRIs. That means it clears the body faster and so it is more obvious that fatigue and pains are related to quitting the drug. With SSRIs that linger in the system for longer, by the time the symptoms appear it may seem that depression has set in again - and so the doctor's answer is another SSRI prescription.
GlaxoSmithKline insists there is no problem with its drug. "There is absolutely no reliable scientific evidence that Paxil is addictive or leads to dependence," said a spokesman.
He added: "As far as we're concerned, all of the regulatory bodies are quite happy with the product."
But Social Audit, which has monitored antidepressant drugs for decades, sees history repeating itself. Morphine was used for years to treat opium addiction. Barbiturates, found to be horribly addictive, were replaced by the benzodiazepines - such as Librium, Valium and Mogadon - which were liberally prescribed as safer and non-addictive. Then came Ativan, which like Paxil/Seroxat had a short half-life, and the symptoms of benzodiazepine dependence became clear.
The SSRIs have largely taken their place, but according to Mr Medawar, little has changed.
---
article: http://www.guardian.co.uk/international/story/0,3604,547560,00.html
