Journal Raises Fresh Concerns Over Antidepressants

[Guest guest]

What's going on with the medical scene? Prozac is another drug besides Ritalin that is given to children with ADHD. Besides it's long history of side-effects, it's still available to the public. Another thing. Vioxx is back on the market. (Below) After it has reportedly killed 140,000 cases of heart disease: http://www.healthtalk.ca/vioxx_study_012505_37989.php

Journal Raises Fresh Concerns Over Antidepressants *Gezondheid/Health | 22 Februari 2005 | 06:06:38

 

LONDON (Reuters) - People taking popular Prozac-type antidepressants may be twice as likely to attempt suicide than those on placebo and the risks are particularly high early in treatment, according to research released on Friday.

 

The British Medical Journal, which published results from three studies on selective serotonin re-uptake inhibitors (SSRIs), said the findings underlined the need for caution in using the medicines.

"How many people who turned to 'happy pills' would not have done so if they had been fully aware of the potential harm?" acting editor Kamran Abbasi wrote in an editorial.

 

One study, pooling results from 702 trials involving 87,000 patients, found a doubling of suicide attempts, although there was no increase in actual suicides.

A second analysis of 477 trials submitted by drug companies to regulators found weak evidence of an increased risk of self-harm but not of suicide, while a third study highlighted a raised risk among under-18s.

Concerns about the safety of SSRIs are not new and drugs including GlaxoSmithKline Plc's Seroxat - the most widely prescribed among the drug class in Britain - were banned from use in children in 2003.

The UK's Medicines and Healthcare Products Regulatory Agency said the latest studies in the BMJ had been taken into account when the regulator issued new guidelines on the use of SSRIs last December.

Those called for doctors to use antidepressants sparingly and, in most cases, to only prescribe the lowest recommended dose.

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. http://www.reuters.com/newsArticle.jhtml?type=healthNews & storyID=7676410

 

 

Even so, on the same day CNN published:

 

Celebrex, Bextra, Vioxx can stay

February 18, 2005: 4:48 PM EST

FDA panel says the painkillers should stay on the market despite risks; Vioxx draws a split vote. WASHINGTON (CNN) - While the painkillers Celebrex, Bextra, and Vioxx significantly increase the risk of cardiovascular problems, the danger is not great enough to justify taking the drugs off the market, according to an advisory committee of the Food and Drug Administration.

 

The advisory committee voted on whether to stop sales of the drugs Friday during a third and final day of considering the risks associated with taking Cox II selective non-steroidal anti-inflammatory drugs (NSAIDs).

The votes are non-binding. The 32-member panel unanimously agreed that each drug "significantly increases the risk of cardiovascular events." But in a 31-1 vote, the panel decided the overall risk posed by Celebrex is not enough to require removing the drug from the U.S. market. The votes on Bextra and Vioxx were much closer.

 

When considering Bextra -- which many experts say has not been tested as thoroughly -- 17 members agreed the drug should stay on the market, 13 voted against the measure, and the remaining two abstained.

The panel voted 17-15 in favor of continuing sales of Vioxx, which was voluntarily taken off the market in September.

 

When explaining their votes to keep Vioxx on the market, the panel members suggested the FDA issue a stronger "black box" warning label detailing the risks of hypertension and cardiovascular side effects, as well as restrict higher doses of the drug. Other suggestions included monitoring blood pressure in all patients, eliminate the 50 milligram dosage, as well as require informed consent from adult patients

 

Pharmaceutical manufacturer Merck & Co. (Research), which manufactures Vioxx, said in a statement released in reaction to the vote: "Merck has appreciated the opportunity to present data at this advisory committee meeting. We look forward to discussions with the FDA."

 

The committee recommended the FDA take certain actions to warn consumers about Celebrex, including a ban on direct marketing to consumers, a patient guide the drug, and a black box warning -- the highest level of warning that can go on a label -- which will address the cardiovascular risks of taking the medication.

 

"Obviously, drug companies don't like to have these (black box warnings) on their products because it would make a physician think twice or more than that before prescribing it," CNN Medical Correspondent Elizabeth Cohen said.

 

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