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	<title>Comments on: Hormones for menopause: yes or no?</title>
	<link>http://www.bloggernews.net/18857</link>
	<description>High-quality English language analysis and editorial writing on the news.</description>
	<pubDate>Thu, 26 Nov 2009 10:44:58 +0000</pubDate>
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		<title>By: Brian Wendel</title>
		<link>http://www.bloggernews.net/18857#comment-64469</link>
		<dc:creator>Brian Wendel</dc:creator>
		<pubDate>Tue, 24 Jul 2007 12:10:53 +0000</pubDate>
		<guid>http://www.bloggernews.net/18857#comment-64469</guid>
		<description>Hello Nancy,

Your site is very informative and I greatly enjoyed the picture of the menopause symptoms.

I'd like to share with a new advancement in menopause treatment options -- Elestrin (www.elestrin.com) -- it is the lowest effective dose of estrogen therapy for the treatment of hot flashes associated with menopause.  With all of the news recently about the NEJM study and the U-turn on the WHI Study, this is the kind of news your readers need to hear to reaffirm that HT is safe and effective for women in their 40s and 50s.

Please let me know if you'd like any additional information - thanks.
- Brian Wendel (212) 829-0002 ext. 103

New, Effective Low Dose Estrogen Therapy 
Introduced to National Media  

Elestrin Represents An Effective Low Dose Treatment Option to Treat Hot Flashes 

New York (June 20, 2007) – Bradley Pharmaceuticals, Inc. (NYSE: BDY) today introduced Elestrin™ (estradiol gel 0.06%) to the national media. Elestrin is an effective, low dose transdermal estrogen therapy approved by the Food and Drug Administration (FDA) in December 2006 for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Elestrin was launched last week by the Company’s Kenwood Therapeutics division and is now available by prescription at pharmacies nationwide.

An editors’ launch meeting was held today in New York City led by Marie Lugano, founder of the American Menopause Foundation. Dr. Michelle Warren of Columbia University, a key opinion leader on menopause, provided an overview of the menopause marketplace. Dr. Michael Snabes, an expert in the field of reproductive endocrinology, provided information on clinical studies about Elestrin.

“Every woman is unique, and so is the way she experiences menopause,” said Ms. Lugano.  “It is critical, therefore, that women research the issues, understand the various treatment options available, and discuss them with their doctor.  Armed with the right information, women can   better manage their menopause symptoms effectively.”

“Menopause therapy is shifting toward low-dose regimens, and Elestrin™ offers women a new, effective low dose treatment option,” said Daniel Glassman, President and CEO of Bradley Pharmaceuticals.  “Elestrin™ addresses the guidelines set forth by the FDA, American College of Obstetricians and Gynecologists (ACOG), North American Menopause Society (NAMS), and the New England Journal of Medicine that hormone therapy should be used at a low effective dose for the shortest duration of time.” 

In addition to being an effective low dose estrogen therapy, Elestrin™ dries quickly within five minutes and is applied once-daily over a small area of the upper arm and/or shoulder. 

Dr. Michael Snabes, co-author of “Low Dose of Transdermal Estradiol Gel for the Treatment of Symptomatic Postmenopausal Women,” which was published in the March 2007 edition of Journal of Obstetrics &#38; Gynecology, noted that “During the 12-week clinical trial, Elestrin was proven to significantly reduce the frequency and severity of hot flashes.  Reductions in both the frequency and severity of hot flashes varied depending on the dosage.”

“We now have the option to prescribe a new, low effective dose of estrogen therapy to patients,” said Dr. Michelle Warren, Medical Director of The Center for Menopause, Hormonal Disorders and Women’s Health at Columbia University.  “Elestrin™ will provide physicians with an important treatment option for patients who choose to manage their hot flashes.”

Important Product Safety Information About Elestrin:

Close clinical surveillance of all women taking estrogens is important.  Adequate diagnostic measures should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. 

Long-term continuous administration of estrogen, with or without progestin, has shown an increased risk of endometrial, breast and ovarian cancers.

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.  An increased risk of developing probable dementia in postmenopausal women 65 years of age or older was reported with estrogen-alone use, as well as, in combination with progestin.

Estrogen-alone therapy has been associated with an increased risk of stroke and deep vein thrombosis.  Estrogen plus progestin therapy has been associated with an increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis.  Estrogens should be discontinued immediately if any of these events occur or are suspected.  

Estrogen with or without progestin should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the patient.

An increase in gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.  Estrogen therapy may lead to severe hypercalcemia in patients with breast cancer and bone metastases.  Retinal vascular thrombosis has been reported in patients receiving estrogens.

Estrogen products should not be used in women with undiagnosed abnormal genital bleeding; known, suspected or history of breast cancer; known or suspected estrogen-dependent neoplasia; active or history of deep vein thrombosis or pulmonary embolism; active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease; known or suspected pregnancy.

Blood pressure should be monitored during estrogen use.  Caution should be exercised in patients with hypertriglyceridemia, impaired liver function or a history of cholestatic jaundice, conditions that might be influenced by fluid retention, hypocalcemia, asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas.  Patients dependent on thyroid hormone replacement therapy may require increased doses of such therapy.  The addition of progestin should be considered in patients with residual endometriosis post-hysterectomy.  Concomitant application of sunscreen and ElestrinTM to the same site for more than 7 days should be avoided.  

For additional important information about Elestrin™, please view full prescribing information at www.bradpharm.com or request full prescribing information by contacting Bradley Pharmaceuticals at 973-882-1505.</description>
		<content:encoded><![CDATA[<p>Hello Nancy,</p>
<p>Your site is very informative and I greatly enjoyed the picture of the menopause symptoms.</p>
<p>I&#8217;d like to share with a new advancement in menopause treatment options &#8212; Elestrin (www.elestrin.com) &#8212; it is the lowest effective dose of estrogen therapy for the treatment of hot flashes associated with menopause.  With all of the news recently about the NEJM study and the U-turn on the WHI Study, this is the kind of news your readers need to hear to reaffirm that HT is safe and effective for women in their 40s and 50s.</p>
<p>Please let me know if you&#8217;d like any additional information - thanks.<br />
- Brian Wendel (212) 829-0002 ext. 103</p>
<p>New, Effective Low Dose Estrogen Therapy<br />
Introduced to National Media  </p>
<p>Elestrin Represents An Effective Low Dose Treatment Option to Treat Hot Flashes </p>
<p>New York (June 20, 2007) – Bradley Pharmaceuticals, Inc. (NYSE: BDY) today introduced Elestrin™ (estradiol gel 0.06%) to the national media. Elestrin is an effective, low dose transdermal estrogen therapy approved by the Food and Drug Administration (FDA) in December 2006 for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Elestrin was launched last week by the Company’s Kenwood Therapeutics division and is now available by prescription at pharmacies nationwide.</p>
<p>An editors’ launch meeting was held today in New York City led by Marie Lugano, founder of the American Menopause Foundation. Dr. Michelle Warren of Columbia University, a key opinion leader on menopause, provided an overview of the menopause marketplace. Dr. Michael Snabes, an expert in the field of reproductive endocrinology, provided information on clinical studies about Elestrin.</p>
<p>“Every woman is unique, and so is the way she experiences menopause,” said Ms. Lugano.  “It is critical, therefore, that women research the issues, understand the various treatment options available, and discuss them with their doctor.  Armed with the right information, women can   better manage their menopause symptoms effectively.”</p>
<p>“Menopause therapy is shifting toward low-dose regimens, and Elestrin™ offers women a new, effective low dose treatment option,” said Daniel Glassman, President and CEO of Bradley Pharmaceuticals.  “Elestrin™ addresses the guidelines set forth by the FDA, American College of Obstetricians and Gynecologists (ACOG), North American Menopause Society (NAMS), and the New England Journal of Medicine that hormone therapy should be used at a low effective dose for the shortest duration of time.” </p>
<p>In addition to being an effective low dose estrogen therapy, Elestrin™ dries quickly within five minutes and is applied once-daily over a small area of the upper arm and/or shoulder. </p>
<p>Dr. Michael Snabes, co-author of “Low Dose of Transdermal Estradiol Gel for the Treatment of Symptomatic Postmenopausal Women,” which was published in the March 2007 edition of Journal of Obstetrics &amp; Gynecology, noted that “During the 12-week clinical trial, Elestrin was proven to significantly reduce the frequency and severity of hot flashes.  Reductions in both the frequency and severity of hot flashes varied depending on the dosage.”</p>
<p>“We now have the option to prescribe a new, low effective dose of estrogen therapy to patients,” said Dr. Michelle Warren, Medical Director of The Center for Menopause, Hormonal Disorders and Women’s Health at Columbia University.  “Elestrin™ will provide physicians with an important treatment option for patients who choose to manage their hot flashes.”</p>
<p>Important Product Safety Information About Elestrin:</p>
<p>Close clinical surveillance of all women taking estrogens is important.  Adequate diagnostic measures should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. </p>
<p>Long-term continuous administration of estrogen, with or without progestin, has shown an increased risk of endometrial, breast and ovarian cancers.</p>
<p>Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.  An increased risk of developing probable dementia in postmenopausal women 65 years of age or older was reported with estrogen-alone use, as well as, in combination with progestin.</p>
<p>Estrogen-alone therapy has been associated with an increased risk of stroke and deep vein thrombosis.  Estrogen plus progestin therapy has been associated with an increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis.  Estrogens should be discontinued immediately if any of these events occur or are suspected.  </p>
<p>Estrogen with or without progestin should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the patient.</p>
<p>An increase in gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported.  Estrogen therapy may lead to severe hypercalcemia in patients with breast cancer and bone metastases.  Retinal vascular thrombosis has been reported in patients receiving estrogens.</p>
<p>Estrogen products should not be used in women with undiagnosed abnormal genital bleeding; known, suspected or history of breast cancer; known or suspected estrogen-dependent neoplasia; active or history of deep vein thrombosis or pulmonary embolism; active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease; known or suspected pregnancy.</p>
<p>Blood pressure should be monitored during estrogen use.  Caution should be exercised in patients with hypertriglyceridemia, impaired liver function or a history of cholestatic jaundice, conditions that might be influenced by fluid retention, hypocalcemia, asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas.  Patients dependent on thyroid hormone replacement therapy may require increased doses of such therapy.  The addition of progestin should be considered in patients with residual endometriosis post-hysterectomy.  Concomitant application of sunscreen and ElestrinTM to the same site for more than 7 days should be avoided.  </p>
<p>For additional important information about Elestrin™, please view full prescribing information at <a href="http://www.bradpharm.com" rel="nofollow">http://www.bradpharm.com</a> or request full prescribing information by contacting Bradley Pharmaceuticals at 973-882-1505.</p>
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