The makers of a leading
antidepressant of the Prozac class have been forced to issue a new warning
to patients and doctors, acknowledging that some people get hooked and
might suffer severe side effects when they try to stop taking it.
GlaxoSmithKline, the British drug company which makes the best-seller
Seroxat, was yesterday also found to be in breach of the industry's code
of practice by misleading the public after one of its executives said on
television that reports of withdrawal symptoms were "very rare".
The new warning for Seroxat was demanded by the food and drug
administration, which licenses medicines in the United States. It is a
severe blow to the makers of SSRIs (selective serotonin reuptake
inhibitors), which were launched in the 80s as wonder drugs which had none
of the addiction problems of the benzodiazepines such as Valium and
Ativan.
The warning says that patients must be monitored for side effects
associated with physical dependency on the drug. "A gradual reduction in
the dose rather than abrupt cessation is recommended whenever possible,"
it says, and if "intolerable symptoms occur" the patient might have to go
back on the full dose and be weaned off more gradually.
Recent trials for new uses of the drug - for instance, in cases of
post-traumatic stress disorder - found that even with a gradual reduction
in the dose, at least two in every 100 people suffered abnormal dreams or
pains resembling electric shocks, and seven in every 100 experienced
dizziness, the FDA said. It added that similar side effects had been
reported for the other SSRIs, including Prozac.
GlaxoSmithKline has long denied that its drug could cause dependency.
Last year one of its executives stated on ABC television in the US that
"it happens very rarely". The British watchdog Social Audit complained
that the comment was misleading and breached the International Federation
of Pharmaceutical Manufacturers' Associations code of practice.
The case went to appeal, but yesterday the federation found
GlaxoSmithKline to be in breach of the code, ruling that the comment
constituted promotion of the drug and that it was wrong. Side effects did
not occur "very rarely" (technically one in 10,000 cases) but were "rare"
(one in 1,000 cases), the federation said.
Charles Medawar of Social Audit welcomed the ruling but noted that the
industry was still dragging its feet, because the FDA warning on Seroxat
acknowledged that side effects occurred "frequently" (more than one in 100
cases).
"What is the company now going to do to undo the harm it has done?" he
asked. "The new warning says nothing that wasn't obvious five years ago.
It won't be long before the FDA has to change it again. If it reflects
reality, it will say that a small but significant minority of patients
will never be able to get off this drug."
Mr Medawar called for drug companies to investigate what happened to
the people prescribed SSRIs for months or years. Their information was
mostly over 10 years old and obtained from trials on volunteers taking the
drugs for short periods. His website (www.socialaudit.org.uk) contains
testimony from about 500 people who had distressing side effects and were
usually not believed by doctors, because of the absence of any warning
from the manufacturer.
A court action has been filed in the US by patients who say their lives
have been blighted by dependency on Seroxat, and two firms of solicitors
in Britain have at least 60 people on their books.
