Weight-loss Drug Pulled Over Heart, Stroke Risks
Tuesday, October 12th 2010
A popular weight-loss medicine is being withdrawn from sale because it has been linked to an increased risk of heart attacks and strokes, mostly in patients known to have cardiovascular disease.
The withdrawal is despite the fact that under its New Zealand licence, the drug is not supposed to be prescribed to people with a history of cardiovascular disease.
Pharmaceutical company Abbott said it had decided, in consultation with regulators in New Zealand, Australia, the United States and Canada, to stop selling Reductil.
Abbott suggested patients who have been using the drug should see their doctor to discuss other ways to lose weight.
It advises doctors to stop prescribing the drug and pharmacists to cease dispensing it.
The Health Ministry said yesterday the Medicines Adverse Reactions Committee, which advises Health Minister Tony Ryall, had recommended Reductil's licence be revoked.
This follows reviews of the safety of the drug and its active ingredient, sibutramine, by the committee and the ministry's Medsafe unit.
"We have concluded that the risks of using sibutramine outweigh any benefit from the very modest weight loss observed when using the medicine," said Medsafe's principal clinical adviser, Dr Enver Yousuf.
The European Union revoked its consent in January after a six-year study of 10,000 patients. Preliminary results linked the drug to an increased risk of heart attacks and strokes.
But Abbott's head of corporate communications for Australia and New Zealand, Jennifer Stevenson, said yesterday that 90 per cent of the study's patients were at high risk of cardiovascular events such as a heart attack.
The company stands by its assessment of the drug as having a positive benefit/risk ratio when used for weight-loss by an "appropriate population", such as those for whom it was licensed in New Zealand.
These were obese or overweight people, with no history of cardiovascular disease, who had been unable to lose weight through diet and exercise.
Patients paid about $70 a month for Reductil, originally developed as an antidepressant.
No figures are available on the number of New Zealand patients using Reductil, but an Otago University study published in June said it was prescribed to 17,000 patients, mainly women, in the three years from 2001, when it was first sold in New Zealand.
Auckland GP Dr Peter Didsbury, chairman of ProCare Health, said he stopped prescribing Reductil several months ago because of the emerging concerns, although he had not seen any adverse reactions to the medicine.
"I often found people initially were successful in using it, but since they stopped using the medication ... they regained weight. There's no real benefit if that happens."
Dr Didsbury said he only rarely prescribed another weight-loss drug, Xenical.
"Medication is only a very small part of weight control. The fundamental thing is diet and exercise."
Sourced from Martin Johnston written for the NZ Herald.
12th October 2010
Footnote from Leanne James:
Thank goodness this drug has finally been withdrawn. We published a news item back in December 2009 talking about how Medsafe was aware of international concerns about this weight-loss drug and that it was reviewing the risks. We mentioned how we personally know of a woman in her 20s who did suffer a heart attack while taking this drug, but when admittted to hospital they denied that it could be responsible for her near death experience.
You can view the Medicine Data Sheets on Medsafes website by going here Datasheets. I go to the Alphabetical listing of data sheets and look the drug up this way. If its not listed, do a google search for the medicine you are interested in and you may find another name for it. These data sheets are reguarly updated and are a good way to check for the known side effects of the drug.
The following are all helpful for Stroke Prevention:
Hi Strength Q10 Absorb 6X 150mg
Fish Oil 1500mg Odourless
Enzo Brain Recovery Program
Hi Strength Liquid Fish Oil
Circulate with Bioactive Ginger
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