/PRNewswire/ -- The U.S. Food and Drug Administration is warning that inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets.
Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. The FDA currently is reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product.
"Women using Evamist need to be aware of the potential risks to children who come in contact with the area of skin where this drug is applied," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III. "It is important that people know to keep both children and pets away from the product to minimize exposure."
Evamist was FDA approved in 2007. From July 2007 to June 2010, FDA received eight post-marketing cases of unintended exposure to Evamist in children ages 3 years to 5 years. Adverse events reported in unintentionally exposed children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males. Since 2007, two reports of secondary exposure to Evamist in dogs also have been received by FDA's Center for Veterinary Medicine. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling.
Patients using Evamist should not allow children to make contact with the area of the arm where Evamist is sprayed and should wash the child's skin with soap and water as soon as possible if contact does occur. Pets also should not be allowed to lick or touch the arm where Evamist is sprayed as small pets may be especially sensitive to the estrogen in this product. If direct contact with the arm where Evamist was sprayed cannot be avoided, it is recommended that women wear a garment that covers the area where the drug was applied.
At this time, it is unknown whether unintended exposure can occur with other topical estrogen products. The FDA is continuing to review adverse event reports and evaluate ways to reduce unintended exposures to these products.
Consumers and health care professionals should report any side effects from Evamist by using the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.
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Showing posts with label hormones. Show all posts
Showing posts with label hormones. Show all posts
Thursday, July 29, 2010
Friday, December 11, 2009
Dangerous Contraceptive Drug Yaz and Yasmine Raise Serious Health Risks
Some women may have sustained serious injury after taking contraceptives under the names "Yaz" "Yasmin" or "Ocella." Use of the drug may cause strokes, heart attacks, DVT (blood clots in legs), Pulmonary Embolism (blood clots in lungs, and dehydration, leading to kidney stones or gall bladder disease.
What is Yaz?
Yasmin and Yaz are contraceptive drugs produced by Bayer Healthcare. Yasmin and Yaz are known as "fourth generation" combination oral birth control drugs because they contain a combination of the hormones estrogen (ethinyl estradiol) and progestin (drospirenone). Yasmin was approved for use in the United States in 2001, while Yaz, a lower dose version, was approved for use in 2006. It is marketed under the name Ocella as a generic brand. The difference between Yaz and Yasmine is in the amount of the estrogen component, ethinyl estradiol. Yasmin contains 30 mcg ethinyl estradiol, while Yaz contains a lower dose of 20 mcg. This contraceptive is one of the most popular contraceptives and has been heavily marketed to women throughout the United States promoting its use in treating premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD).
Why is Yaz dangerous?
There are several reasons.
Dehydration. This key ingredient Drospirenone may cause dehydration and then increase potassium levels in the blood, which, according to the Food and Drug Administration (FDA), can be dangerous. Dehydration can lead to kidney stones and gallbladder disease.
Heart Problems. Potassium acts as a critical control in cardiac rhythm. Because of that, this imbalance can cause heart rhythm disturbances. This process can result in a stroke, heart attack, the formation of blood clots, deep vein thrombosis (DVT), pulmonary embolism, and even death.
Blood clot conditions including DVT and Pulmonary Embolism are serious Yaz side effect reported by women using this fourth-generation birth control pill. Many women with no family history of blood clots have suffered from life threatening injuries involving clots. The type of hormones in birth control pills can increase the risk of developing blood clots which can lead to serious problems especially if they are not diagnosed early.
After having a blood clot many women are then faced with life-changing side effects including being on blood thinners, pain in the area of the clot, and increased risk of developing another clot.
One of the more serious conditions reported by women who used Yaz or Yasmine are strokes. There are two main types of strokes: ischemic stroke (caused by blockage) and hemorrhagic stroke (caused by bleeding). Women who are otherwise healthy with no prior stroke problems have experienced a stroke where no other health issues exist. After having a stroke many women are then faced with life-changing side effects including permanent loss of movement, difficulty communicating and permanent loss of brain functions.
Quality Control. Recently, the FDA has taken action against Bayer to limit the drug's entry into the nation from Germany where it is manufactured citing serious quality control issues.
Has Bayer Properly Warned You About the Risks?
Bayer has also been cited by the FDA for overstating the benefits of Yaz and understating the risks in taking the contraceptive in its marketing of the drug. As part of an agreement with the FDA and more than two dozen state legal officials, Bayer was pressured into removing the ads, but is still marketing the drug with a new ad campaign which started early in 2009. "Those products were the company's top-selling pharmaceuticals last year, with global sales of $1.8 billion," according to The New York Times.
Article provided by Marcus & Mack
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What is Yaz?
Yasmin and Yaz are contraceptive drugs produced by Bayer Healthcare. Yasmin and Yaz are known as "fourth generation" combination oral birth control drugs because they contain a combination of the hormones estrogen (ethinyl estradiol) and progestin (drospirenone). Yasmin was approved for use in the United States in 2001, while Yaz, a lower dose version, was approved for use in 2006. It is marketed under the name Ocella as a generic brand. The difference between Yaz and Yasmine is in the amount of the estrogen component, ethinyl estradiol. Yasmin contains 30 mcg ethinyl estradiol, while Yaz contains a lower dose of 20 mcg. This contraceptive is one of the most popular contraceptives and has been heavily marketed to women throughout the United States promoting its use in treating premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD).
Why is Yaz dangerous?
There are several reasons.
Dehydration. This key ingredient Drospirenone may cause dehydration and then increase potassium levels in the blood, which, according to the Food and Drug Administration (FDA), can be dangerous. Dehydration can lead to kidney stones and gallbladder disease.
Heart Problems. Potassium acts as a critical control in cardiac rhythm. Because of that, this imbalance can cause heart rhythm disturbances. This process can result in a stroke, heart attack, the formation of blood clots, deep vein thrombosis (DVT), pulmonary embolism, and even death.
Blood clot conditions including DVT and Pulmonary Embolism are serious Yaz side effect reported by women using this fourth-generation birth control pill. Many women with no family history of blood clots have suffered from life threatening injuries involving clots. The type of hormones in birth control pills can increase the risk of developing blood clots which can lead to serious problems especially if they are not diagnosed early.
After having a blood clot many women are then faced with life-changing side effects including being on blood thinners, pain in the area of the clot, and increased risk of developing another clot.
One of the more serious conditions reported by women who used Yaz or Yasmine are strokes. There are two main types of strokes: ischemic stroke (caused by blockage) and hemorrhagic stroke (caused by bleeding). Women who are otherwise healthy with no prior stroke problems have experienced a stroke where no other health issues exist. After having a stroke many women are then faced with life-changing side effects including permanent loss of movement, difficulty communicating and permanent loss of brain functions.
Quality Control. Recently, the FDA has taken action against Bayer to limit the drug's entry into the nation from Germany where it is manufactured citing serious quality control issues.
Has Bayer Properly Warned You About the Risks?
Bayer has also been cited by the FDA for overstating the benefits of Yaz and understating the risks in taking the contraceptive in its marketing of the drug. As part of an agreement with the FDA and more than two dozen state legal officials, Bayer was pressured into removing the ads, but is still marketing the drug with a new ad campaign which started early in 2009. "Those products were the company's top-selling pharmaceuticals last year, with global sales of $1.8 billion," according to The New York Times.
Article provided by Marcus & Mack
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Tuesday, November 03, 2009
Toxic BPA Contamination - Groups Support Consumers Union Call for FDA Protection From BPA in Canned Food
/PRNewswire/ -- In response to Consumer Reports' new report on contamination of canned food products with the synthetic sex hormone bisphenol A (BPA), the Breast Cancer Fund, Clean Water Action, Clean New York, Center for Health, Environment & Justice, Physicians for Social Responsibility, Oregon Toxics Alliance and other environmental health advocates support Consumers Union's call for FDA to immediately act to protect consumers from BPA.
BPA is linked to neurological, endocrine and reproductive health effects, breast cancer and other serious health problems.
"Consumer Reports' results are sobering, and confirm what we already know: Americans are exposed to toxic BPA every day through canned food," said Janet Nudelman at the Breast Cancer Fund. "A synthetic estrogen linked to breast cancer should not be in our food, period. It's well past time to ban BPA from food and beverage containers."
Bobbi Chase Wilding of Clean New York says, "Consumers should not have to read scientific journals to determine what is safe when shopping for their families. FDA needs to step up and step in."
Mike Schade from the Center for Health, Environment & Justice adds, "We know there are companies that want to do the right thing. Wal-Mart, Target, Babies R Us, Nalgene, CamelBak and others have been working provide their customers with safer, BPA-free products -- the products consumers want. The time has come for the food industry to follow suit."
The product testing found that almost all of the 19 name-brand foods tested contain measurable levels of bisphenol A (BPA). Results are in the December 2009 issue and are available free online at www.ConsumerReports.org
Consumers Union sent a letter to FDA Commissioner Margaret Hamburg requesting that it move this year to ban the use of BPA in food- and beverage-contact materials.
Congress is currently considering legislation that would ban the use of BPA in all food and beverage containers.
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BPA is linked to neurological, endocrine and reproductive health effects, breast cancer and other serious health problems.
"Consumer Reports' results are sobering, and confirm what we already know: Americans are exposed to toxic BPA every day through canned food," said Janet Nudelman at the Breast Cancer Fund. "A synthetic estrogen linked to breast cancer should not be in our food, period. It's well past time to ban BPA from food and beverage containers."
Bobbi Chase Wilding of Clean New York says, "Consumers should not have to read scientific journals to determine what is safe when shopping for their families. FDA needs to step up and step in."
Mike Schade from the Center for Health, Environment & Justice adds, "We know there are companies that want to do the right thing. Wal-Mart, Target, Babies R Us, Nalgene, CamelBak and others have been working provide their customers with safer, BPA-free products -- the products consumers want. The time has come for the food industry to follow suit."
The product testing found that almost all of the 19 name-brand foods tested contain measurable levels of bisphenol A (BPA). Results are in the December 2009 issue and are available free online at www.ConsumerReports.org
Consumers Union sent a letter to FDA Commissioner Margaret Hamburg requesting that it move this year to ban the use of BPA in food- and beverage-contact materials.
Congress is currently considering legislation that would ban the use of BPA in all food and beverage containers.
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Wednesday, July 29, 2009
Researchers Skew Data?
TT Note: Some researchers have long been known to use selection bias so their studies will show the results they want. Not all researchers do this. It would be nice if we didn't use our bias history as we make deductions now. Hey, didn't I just do that?
I thought this article was interesting. Perhaps the possibility of an increased breast cancer risk will make some women think twice or three times.....
Study: Turkish Women with Abortions Have Statistically Significant 66% Increase in Breast Cancer Risk / Researchers Likely Underestimated the Risk, Reports Scientist
/Standard Newswire/ -- I guess they didn't get the 'memo' from the U.S. National Cancer Institute (NCI), which declared back in 2003 that the non-existence of the ABC (abortion-breast cancer) link had been 'established'"! - Professor Joel Brind, Breast Cancer Prevention Institute
A retrospective study conducted by Dr. Vahit Ozmen and his colleagues at the Istanbul Medical Faculty and Magee-Women's hospital reported a statistically significant 66% increase in breast cancer risk among women who'd had any abortions.
According to Joel Brind, professor of endocrinology at Baruch College, City University of New York and a director at the Breast Cancer Prevention Institute, Ozmen's team most likely underestimated the breast cancer risk associated with abortion because of a flaw known as "selection bias."
Selection bias would also explain their team's unusual findings - significantly decreased risks for
women who use oral contraceptives (OCs) and hormone replacement therapy (HRT). The World
Health Organization and the NCI acknowledge that use of combined (estrogen + progestin) OCs and combined HRT increase risk.
Selection bias is a flaw in the study because only hospital or clinic patients were selected as study
subjects, and they were therefore not representative of the general population. According to Brind's hypothesis, a disproportionate number of "modern" women were likely represented among the controls, a group more likely to use HRT and OCs, have abortions and visit the hospital often for minor complaints. By contrast, a disproportionate number of "traditional" women were represented among the patients; women less likely to use HRT and OCs, have abortions and visit the hospital (except in cases of serious illness, like breast cancer).
To their credit, Dr. Ozmen et al. did acknowledge the likelihood of selection bias in their study, although they were not specific in attributing any effects on their results to it.
Brind's analysis of Ozmen's research can be read
here:
www.abortionbreastcancer.com/download/
BrindTurkishStudy.pdf (http://rs6.net/tn.jsp?et=1102652862893&s=13633&e=001xxmgfXy49dLCmcC1PHAHANLDqnoIurCPs85rTzPiEBdoGHzu_EyXBIgnNH6qacd9SJ5QxORxBoh97fV4PkI-sbJB_X2k8X7e1s_XwZjyXK4aFgn8S6TxYCLwmx_bhI2ytTImi5kWc-Lp_jZ-Y0-h-PM2aTTHWIqx-W-PgaUWj_Q=)
"Although the NCI, the nation's largest funder of cancer-research, and others have worked feverishly to suppress the ABC link by publishing fraudulent research and even leaning on scientists whose studies have shown risk increases among women who have abortions, honest research occasionally escapes the NCI's purview," declared Karen Malec, president of the Coalition on Abortion/Breast Cancer.
The Coalition on Abortion/Breast Cancer is an international women's organization founded to protect the health and save the lives of women by educating and providing information on abortion as a risk factor for breast cancer.
-----
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I thought this article was interesting. Perhaps the possibility of an increased breast cancer risk will make some women think twice or three times.....
Study: Turkish Women with Abortions Have Statistically Significant 66% Increase in Breast Cancer Risk / Researchers Likely Underestimated the Risk, Reports Scientist
/Standard Newswire/ -- I guess they didn't get the 'memo' from the U.S. National Cancer Institute (NCI), which declared back in 2003 that the non-existence of the ABC (abortion-breast cancer) link had been 'established'"! - Professor Joel Brind, Breast Cancer Prevention Institute
A retrospective study conducted by Dr. Vahit Ozmen and his colleagues at the Istanbul Medical Faculty and Magee-Women's hospital reported a statistically significant 66% increase in breast cancer risk among women who'd had any abortions.
According to Joel Brind, professor of endocrinology at Baruch College, City University of New York and a director at the Breast Cancer Prevention Institute, Ozmen's team most likely underestimated the breast cancer risk associated with abortion because of a flaw known as "selection bias."
Selection bias would also explain their team's unusual findings - significantly decreased risks for
women who use oral contraceptives (OCs) and hormone replacement therapy (HRT). The World
Health Organization and the NCI acknowledge that use of combined (estrogen + progestin) OCs and combined HRT increase risk.
Selection bias is a flaw in the study because only hospital or clinic patients were selected as study
subjects, and they were therefore not representative of the general population. According to Brind's hypothesis, a disproportionate number of "modern" women were likely represented among the controls, a group more likely to use HRT and OCs, have abortions and visit the hospital often for minor complaints. By contrast, a disproportionate number of "traditional" women were represented among the patients; women less likely to use HRT and OCs, have abortions and visit the hospital (except in cases of serious illness, like breast cancer).
To their credit, Dr. Ozmen et al. did acknowledge the likelihood of selection bias in their study, although they were not specific in attributing any effects on their results to it.
Brind's analysis of Ozmen's research can be read
here:
www.abortionbreastcancer.com/download/
BrindTurkishStudy.pdf (http://rs6.net/tn.jsp?et=1102652862893&s=13633&e=001xxmgfXy49dLCmcC1PHAHANLDqnoIurCPs85rTzPiEBdoGHzu_EyXBIgnNH6qacd9SJ5QxORxBoh97fV4PkI-sbJB_X2k8X7e1s_XwZjyXK4aFgn8S6TxYCLwmx_bhI2ytTImi5kWc-Lp_jZ-Y0-h-PM2aTTHWIqx-W-PgaUWj_Q=)
"Although the NCI, the nation's largest funder of cancer-research, and others have worked feverishly to suppress the ABC link by publishing fraudulent research and even leaning on scientists whose studies have shown risk increases among women who have abortions, honest research occasionally escapes the NCI's purview," declared Karen Malec, president of the Coalition on Abortion/Breast Cancer.
The Coalition on Abortion/Breast Cancer is an international women's organization founded to protect the health and save the lives of women by educating and providing information on abortion as a risk factor for breast cancer.
-----
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Monday, January 07, 2008
Vaccinations and Autism
I almost hesitate to mention the topic. There are some passionate beliefs on both sides of the issue of vaccinations. The number of children suffering from Autism is growing and many have believed that a component in vaccines contributed to or caused the problem.
The study below seems to refute the belief that vaccinations might cause Autism.
So, if it's not vaccinations, what is it? Why are the numbers increasing? Diet? Toxins in our foods? Pesticides? Hormones in foods?
For a while I was using a product that, among other things, purported to somewhat counteract the affects of vaccines. It was supposed to neutralize the metals we take into our system. I tried it for about a year and didn't see any health benefits. It was expensive so I stopped taking it. However, I had a good friend who's daughter was Autistic. She gave her daughter the same product and noticed a striking improvement. Her therapists, who had not been told about the inclusion of the product into her diet, independently reported a marked difference in her abilities.
I saw the little girl a few times before she took the product. She was removed, it was impossible to understand what she was saying and touch was out of the question. About 6 months later I saw her. I noted a huge difference. Her speech was clear enough I didn't have any trouble understanding what she was saying. She responded to the people around her. I won't bore you with all of the little differences I noted, but overall it was remarkable.
Her mom had done quite a bit of research and was fairly well convinced that vaccines had been the trigger.
I don't know. I suppose I'll be spending a little time wandering around the Internet again doing some reading!
Here's the article. Let me know what you think about vaccines.
California autism cases continue to grow
LOS ANGELES - Autism cases in California continued to climb even after a mercury-based vaccine preservative that some people blame for the neurological disorder was removed from routine childhood shots, a new study found.
http://news.yahoo.com/s/ap/20080107/ap_on_he_me/autism_cases
The study below seems to refute the belief that vaccinations might cause Autism.
So, if it's not vaccinations, what is it? Why are the numbers increasing? Diet? Toxins in our foods? Pesticides? Hormones in foods?
For a while I was using a product that, among other things, purported to somewhat counteract the affects of vaccines. It was supposed to neutralize the metals we take into our system. I tried it for about a year and didn't see any health benefits. It was expensive so I stopped taking it. However, I had a good friend who's daughter was Autistic. She gave her daughter the same product and noticed a striking improvement. Her therapists, who had not been told about the inclusion of the product into her diet, independently reported a marked difference in her abilities.
I saw the little girl a few times before she took the product. She was removed, it was impossible to understand what she was saying and touch was out of the question. About 6 months later I saw her. I noted a huge difference. Her speech was clear enough I didn't have any trouble understanding what she was saying. She responded to the people around her. I won't bore you with all of the little differences I noted, but overall it was remarkable.
Her mom had done quite a bit of research and was fairly well convinced that vaccines had been the trigger.
I don't know. I suppose I'll be spending a little time wandering around the Internet again doing some reading!
Here's the article. Let me know what you think about vaccines.
California autism cases continue to grow
LOS ANGELES - Autism cases in California continued to climb even after a mercury-based vaccine preservative that some people blame for the neurological disorder was removed from routine childhood shots, a new study found.
http://news.yahoo.com/s/ap/20080107/ap_on_he_me/autism_cases
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