Posted by biohazard2 on December 6, 2004, at 11:39:11
Britain Tightens Antidepressant Rules
1 hour, 21 minutes ago Health - Reuters
By Ben Hirschler, European Pharmaceuticals Correspondent
LONDON (Reuters) - British health authorities tightened warnings on popular Prozac-type antidepressants on Monday, urging doctors to use them sparingly and consider non-drug interventions, such as counseling.
The Medicines and Healthcare Products Regulatory Agency (MHRA), which reviewed the medicines after concerns over their safety, demanded stronger warnings about the risk of withdrawal symptoms after ending a course of treatment.
Doctors should only prescribe the lowest recommended dose of selective serotonin re-uptake inhibitors (SSRIs), in most cases, and young adults should be monitored closely as a precautionary measure when being treated, it added.
No type of antidepressant is recommended for the initial treatment of mild depression.
Overall, the MHRA still decided that the benefits of most SSRIs outweighed the risk of adverse drug reactions in adults -- but it highlighted potential problems with Wyeth's product Efexor, use of which will be restricted.
New guidelines say the drug, which is sold as Effexor in the United States, should only be prescribed by specialist doctors and it should not be given to patients with heart disease.
The move follows evidence that Efexor is involved in a higher rate of deaths from overdose than other SSRIs and that it may affect heart function.
WYETH CHALLENGE
Wyeth, whose stock was down 4.3 percent at $39.78 in early trade on Wall Street, said it would challenge the MHRA action.
"We are concerned that today's news will restrict patient access to the SSRIs and venlafaxine (Efexor) for this serious illness," a company spokeswoman said.
Wyeth's British sales of Efexor were $132 million in 2003.
The MHRA appointed a specialist group last year to investigate the safety of SSRIs in adults following claims they could make people feel suicidal or aggressive. Some patients also complained about disturbing withdrawal effects when they came off treatment.
Drugs including GlaxoSmithKline Plc's Seroxat -- the most widely prescribed among the drug class in Britain -- were banned from use in children last year following evidence that they may increase the risk of suicides.
The new review, involving examination of 600 clinical trials, concluded that a modest increase in the risk of suicidal thoughts and self-harm among adults taking SSRIs compared with placebo could not be ruled out.
There was, however, no clear evidence of increased risk of suicide compared with other antidepressants.
Drug companies argue that millions of people have been prescribed SSRIs without suffering major adverse events and that suicidal thoughts are more likely to be the result of their depression rather than the treatment.
'TALKING' TREATMENTS
Coinciding with the MHRA review, the National Institute for Clinical Excellence (news - web sites) (NICE) -- which assesses the cost effectiveness of treatments -- issued new guidelines on depression and anxiety, emphasizing the benefit of non-drug interventions.
For many people with mild to moderate depression, "talking" treatments such as problem-solving therapy, cognitive behavior therapy and counseling could be just as effective as drug therapy, the institute said.
"The guidelines recognize that while medication has an important role to play in treating these conditions, there are also many effective alternatives," said NICE Chief Executive Andrew Dillon.
The MHRA is conducting a separate investigation into whether GlaxoSmithKline, Europe's biggest drugmaker, withheld important data from clinical studies on the suicide risk among teenagers taking Seroxat.
Seroxat, known as Paxil in the United States, used to be GSK's biggest product but it has recently declined in importance following the launch of cheap generic copies in key markets. Eli Lilly & Co has also lost patent protection on Prozac.
Other big SSRI sellers include Pfizer Inc's Zoloft.
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