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Old Wed, Jun-06-01, 15:27
doreen T's Avatar
doreen T doreen T is offline
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Plan: LC paleo/ancestral
Stats: 241/188/140 Female 165 cm
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Location: Eastern ON, Canada
Exclamation Thyroid Drug Under Review for Safety

I have a personal interest in this story .. since I had been prescribed Synthroid for 2 years without improvement .. particularly failing to lose weight in spite of dieting, but many other symptoms as well .. including edema, thinning skin and hair, etc... I convinced my dr. to change the prescription back in March, and I'm glad she did. I have noticed some improvement in fluid retention and my skin and hair is better too. ... Doreen

Most-prescribed drug under review for safety - Thyroid medication taken by 8 million North Americans

by Tom Arnold - National Post

Canada's most commonly prescribed drug is coming under review by the federal Health Department following a warning from the U.S. Food and Drug Administration that Synthroid has a "long history of manufacturing problems" and cannot be seen as "safe" or "effective."

In an April letter to the Abbott Laboratories, the drug's manufacturer, the FDA said Synthroid's problems have included potency failures, recalls and inspection violations.

The failures, the letter stated, indicate that "Synthroid has not been reliably potent and stable" and that when patients take tablets "that are filled with a product of unpredictable potency, therapy with levothyroxine sodium is neither safe nor effective..."

Synthroid offers thyroid replacement for patients suffering from hypothyroidism or other thyroid-related disorders.

More than 8 million people are prescribed the drug in North America. There were 5.6 million prescriptions for the drug dispensed across Canada in 2000.

"We have been made aware of the reports from the U.S., we are taking it very seriously and we are reviewing this information," said Tara Madigan, a spokeswoman for Health Canada.

"We want to determine if the formulation that is being sold in Canada is the same one that there are concerns about in the U.S.

"We want to determine what we have before taking action on it."

Identifying the medication may take Health Canada's Therapeutic Products Program some time since Abbott Laboratories Canada only took over Synthroid's drug identification number four days ago, on May 29. It was formerly manufactured by Knoll Pharma Inc.

The FDA has been compiling data on adverse events associated with the use of Synthroid and its competitors. Canada keeps tabs through the Canadian Adverse Drug Reaction Monitoring Program, but it was not clear yesterday whether specific data has been compiled on the popular thyroid drug.

"We should be very concerned about this because the FDA has been an early warning system on a lot of drugs for us," said Jean Jones, chair of the national health council for the Consumer Association of Canada. "If they have misgivings, it is very significant and we need to pay attention."

Hypothyroidism is a deficiency of thyroid activity. In adults, it is most common in women and is characterized by a decrease in metabolic rate, tiredness and lethargy, sensitivity to cold and menstrual disturbances.

In a press release yesterday, Abbott Laboratories said the safety and efficacy of the drug had been "extensively studied and validated."

"Abbott wants to reassure patients, physicians and pharmacists that Synthroid is a safe and effective treatment for hypothyroidism," the company said.

"Canada has a different regulatory process, so I'm not sure that Canadians have anything to worry about," Laureen Cassidy, director of international public affairs for Abbott Laboratories in Chicago, said in an interview. "This a regulatory issue, not a manufacturing issue.

"The product has had 40 years of history of safe use."


http://www.nationalpost.com/
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Old Thu, Aug-02-01, 04:33
dalene's Avatar
dalene dalene is offline
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Plan: Modified for women induction between 10-15 gms per day
Stats: 135/135/120
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Default Well Which is it?

Hey Doreen,

I have also been on Synthroid for three years now, I am still highly sensitive to cold, fatigued most the time, having menstrual disturbances for the last year or two.

I was told that taking the medicine does not reverse the weight gain you experienced prior to, but helps prevent the future weight gain.

I was a serious runner and NEVER had to diet until I developed this hypothyroid problem. Became withdrawn and reclusive for 5 years gaining 30 pounds before I was diagnosed.

It has been VERY hard getting the 30 pounds off since my hypothyroid problem, even after the discovery and medicine, for instance the only way the low carb diet works for me is to go into extreme, Low calorie, Low fat, and 10 or less carbs a day, then I am lucky to loose 1 or 2 pounds every couple weeks.

Is there a better medicine that you are aware of that I may mention to my doctor???

Dalene
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