Pull Ortho-Evra Birth-Control Patch From Market: Public Citizen
The Ortho-Evra birth control patch exposes women to dangerous levels of estrogen -- posing a possible two-fold increased risk of blood clots -- and should be removed from the market within six months, says a Public Citizen petition filed Thursday with the U.S. Food and Drug Administration.
Compared to women who use standard oral contraceptives, those who use the Ortho-Evra patch experience increased side effects such as breast discomfort, severe menstrual pain, nausea and vomiting, and are more likely to stop using a contraceptive. In addition, the patch doesn't improve birth control, according to evidence compiled by Public Citizen.
Since immediate removal of the Ortho-Evra patch from the market carries the risk that some users may not immediately replace the patch with another form of birth control, Public Citizen suggested a six-month phase-out period. During that time, the patch would be available for refill prescriptions to allow women time to meet with their health-care provider to discuss other forms of birth control.
"Women deserve a level of risk at least comparable to or less than the pill for their hormonal contraceptive. The absence of any evidence of a unique benefit combined with the considerable safety problems of high-dose, variable estrogen exposure in Ortho-Evra tips the balance of risks and benefits against its availability as a contraceptive." Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said in a prepared statement.
The Ortho-Evra patch received FDA approval in 2001.
A spokeswoman for the maker of the patch -- Ortho Women's Health & Urology, a J&J company -- said, "Ortho-Evra is a safe and effective hormonal birth control option when used according to its labeling," the Associated Press reported.
"Hormonal birth control methods have benefits and risks," said Gloria Vanderham. "The approved labeling has always stated the known risks associated with its use."
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U.S. Moves to Tighten Medicare Drug Plan Rules
Tighter controls on Medicare Advantage and Medicare prescription drug plan advertising and marketing are being proposed by the U.S. Centers for Medicare and Medicaid Services, the Orlando Sentinel reported.
Door-to-door marketing and unsolicited telemarketing would be banned and there would be stricter limits on commissions for brokers and agents selling the plans under the proposed regulations, which would also forbid sales activities and limit promotional items in health provider waiting rooms and at health information fairs and community meetings.
The new rules were released Thursday and the public can comment on them until July 15. An agency spokesman said the regulations should be in place by Oct. 1, the Sentinel reported.
These plans can provide valuable benefit to seniors and "should not be undermined by the actions of a limited number of unscrupulous sales agents," said Kerry Weems, acting administrator of the Centers for Medicare and Medicaid Services.
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Too Few People Know All Stroke Symptoms: Study
A U.S. Centers for Disease Control and Prevention study found that only 44 percent of Americans know all five symptoms of stroke and only 38 percent know to call 911 if they think someone is having a stroke.
The analysis of 2005 data from 13 states and the District of Columbia showed that there was no improvement in the public's awareness of stroke symptoms since a similar study in 2001.
It also found significant disparities in awareness of stroke symptoms by race/ethnicity, sex, education level, and state. Blacks, Hispanics and people with lower levels of education were less aware of all five stroke symptoms and the need to call 911 than whites, women, and people with higher levels of education.
The findings appear in this week's issue of the Morbidity and Mortality Weekly Report, published by the CDC.
The five signs and symptoms of stroke include: sudden numbness or weakness in the face, arm, or legs; sudden confusion or trouble speaking or understanding others; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, or loss of balance and coordination; and sudden severe headache with no known cause.
Early recognition of these signs and symptoms and knowing to immediately call 911 can make the difference between life and death. May is National Stroke Awareness Month.
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Attack on Epilepsy Web Site Causes Migraines, Near-Seizures
Some visitors to the Epilepsy Foundation of America's Web site suffered migraines and near-seizures after computer hackers flooded the site with hundreds of pictures and links to pages with rapidly flashing images, the Associated Press reported.
By exploiting a security flaw in the foundation's publishing software, the hackers made numerous support forum posts that were disguised as helpful, but actually led to pages with kaleidoscopic images pulsating with a variety of colors.
"They were out to create seizures," Ken Lowenberg, senior director of web and print publishing for the foundation, told the AP.
The FBI is investigating the attack. Legitimate users can no longer post animated images to the support forum or create direct links to other sites, and the support forum is now moderated around the clock, Lowenberg said.
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Childhood Viral Disease Cases Continue to Climb in China
The number of children in China reported to have hand, foot and mouth disease increased from 15,799 on Tuesday to 19,962 late Wednesday, and the death toll increased from 28 to 30, the Associated Press reported.
The number of reported cases is expected to rise as a result of a Ministry of Health order issued this week requiring health-care workers to report infections within 24 hours, health experts said.
Hand, foot and mouth disease is a common childhood disease that can be caused by different viruses and typically leads to little more than a fever and rash. However, enterovirus 71 can cause a severe form of the disease that can lead to brain swelling, paralysis, or death.
Last year, China recorded 80,000 hand, foot and mouth disease cases, including 17 deaths. But a health ministry spokesman said those figures may have been incomplete because there was no mandatory reporting last year, the AP reported.
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Swing Sets Recalled Due to Fall Hazard
About 17,300 playground swing sets sold across the United States are being recalled because of a defect that may pose a fall hazard, the U.S. Consumer Product Safety Commission said.
The swing sets, made by Playworld Systems Inc., of Lewisburg, Penn., have a clevis bearing that can wear and cause the swing to detach while in use. No injuries have been reported.
The swing sets were sold by authorized dealers to day-care centers and children's learning centers from January 2007 through February 2008 for between $770 and $3,100. The company has sent direct mail notices about the recall to purchasers.
Consumers with the swing sets should remove the swing from the swing set until a free repair kit has been installed, the CPSC said.
For more information, contact Playworld Systems at 1-800-233-8404.
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