- Manufacturers of Prozac and other top-selling antidepressants
have been asked to include stronger warnings in their packaging because
of fears that the drugs could trigger violent behaviour.
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- The Committee on Safety of Medicines (CSM) has also asked
to see unpublished data from early trials that tested their safety in healthy
volunteers, after claims that some individuals became violently depressed
while taking them.
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- Prozac, which was launched by Eli Lilly as a wonder cure
for depression eight years ago, was the first of a generation of antidepressants
called selective serotonin reuptake inhibitors (SSRIs), which were meant
to be free of side-effects.
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- Up to one in 10 of the population experiences depression
at some time and the market for such drugs is worth billions. More than
10m prescriptions for SSRIs are written every year, 3m of them for Prozac.
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- Ramo Kabbani, of the Prozac Survivors Support Group,
a patients' organisation, said it had received more than 2,300 calls in
the past two years about side-effects, half from people who said they had
become suicidal or violent.
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- David Healy, director of the North Wales Psychological
Medicine service in Bangor, is one of a number of specialists who has published
research demonstrating that SSRIs can induce suicidal feelings in healthy
volunteers.
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- Recently Prozac and Seroxat, the other market leader
manufactured by GlaxoSmithKline (GSK) have been the subject of high-profile
legal cases after claims that people had gone berserk while taking them.
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- Last month GSK paid out £4.5m after Seroxat, marketed
as Paxil in America, was blamed for the behaviour of Donald Schell, who
shot dead his wife, daughter and nine- month-old granddaughter and then
killed himself after he was prescribed the drug. In Britain Reginald Payne,
63, suffocated his wife Sally and threw himself off a cliff in Cornwall,
less than a fortnight after he was prescribed Prozac.
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- The proposed change to the leaflet in each packet of
the pills includes the words: "Occasionally thoughts of suicide or
self-harm may occur or may increase in the first few weeks of treatment
. . . tell your doctor immediately if you have any distressing thoughts
or experiences." A spokesman for the CSM said a decision would be
announced this month.
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- Lundbeck and Solvay Healthcare, manufacturers of Cipramil
and Faverin, which have smaller shares of the SSRI market, are expected
to agree to the changes in the packaging, but GSK and Eli Lilly are resisting.
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