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Donna Zuehl

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Another New Medication Approved for Fibromyalgia
1/16/2009 8:01:56 PM

FDA OKs Fibromyalgia Drug Savella

Savella Joins Cymbalta and Lyrica as Drugs Approved for Fibromyalgia Patients
By Miranda Hitti
WebMD Health News
Reviewed by Louise Chang, MD

Jan. 15, 2009 -- The FDA has approved a new drug called Savella for the management of fibromyalgia.

Savella belongs to a class of drugs called serotonin and norepinephrine reuptake inhibitors (SNRIs), which include some antidepressants.

The drug companies behind Savella -- Forest Laboratories Inc. and Cypress Bioscience Inc. -- report that the FDA approved Savella based on two clinical trials that together included 2,084 fibromyalgia patients who took Savella or a placebo for three months or six months.

Savella trumped the placebo in the percentage of patients of who reported at least a 30% reduction in pain and also rated themselves as being "very much improved" or "much improved" in terms of their fibromyalgia, according to a joint news release from Forest Laboratories and Cypress Biosciences.

Savella was safe and generally well tolerated, according to Forest Laboratories and Cypress Biosciences. The drug companies report that nausea was the most common side effect in the clinical trials and that other commonly reported adverse reactions were constipation, hot flush, sweating, vomiting, palpitations, increased heart rate, dry mouth, and hypertension (high blood pressure).

Savella, which is expected to be available by prescription in March, is only approved for adults. It will bear the same "black box" warning as antidepressants about increased risk of suicidal thinking and behavior in children, adolescents, and young adults.

Savella will get a medication guide outlining its risks. And the FDA is requiring postmarketing studies of the pregnancy and fetal outcomes in women who take Savella while pregnant, and a clinical trial of Savella's effects on babies exposed to the drug from breastfeeding.

Other FDA-approved fibromyalgia drugs include the nerve pain drug Lyrica and the SNRI antidepressant Cymbalta. Other antidepressants may be used to treat fibromyalgia but aren't specifically approved by the FDA for that use.

© 2009 WebMD, LLC. All rights reserved.
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Nick Sym

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Re: Another New Medication Approved for Fibromyalgia
1/16/2009 9:26:24 PM
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Donna Zuehl

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Re: Another New Medication Approved for Fibromyalgia
1/17/2009 4:25:53 PM

Hi Nick, My Friend  :)

DonnaZ

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Leonie Parker

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Re: Another New Medication Approved for Fibromyalgia
1/27/2009 6:32:21 PM

Hi Donna,

I imagine this is not available in Australia, but in any case I would prefer to investigate other non-invasive ways to help "fibro". The side effects do not sound as if it is a way to go.

Cheers,

Leonie

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Donna Zuehl

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Re: Another New Medication Approved for Fibromyalgia
1/29/2009 4:56:37 PM
Hi Leonie,

I have fibromyalgia, too, and prefer to avoid medications for it since there really isn't any proof that anything really helps at this point. I take several medications for hypertension since I have a difficult to control case of that, plus other medications deemed necessary, so try to avoid ones I can get along without.

DonnaZ
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