Health Highlights: Dec. 21, 2018
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Announces Safety Monitoring Measures for Essure Birth Control Device
The U.S. Food and Drug Administration is implementing a number of steps for long-term safety monitoring of the permanent birth control device Essure, which will no longer be sold or distributed in the United States after Dec. 31, 2018.
Device maker Bayer announced in July that it would halt sales due to declining use of the device, which has been the subject of a number of FDA safety actions, including being classified as a restricted device.
When Bayer said Essure will no longer be available in the U.S., the FDA said the company must complete the postmarket surveillance study the agency ordered in February 2016. The FDA also said it planned additional steps.
Those measures were announced Thursday and include having women in the postmarket surveillance study followed for five years rather than the initially-required three years.
"This extension will provide us with longer-term information on adverse risks of the device, including issues that may lead women to have the device removed," FDA Commissioner Dr. Scott Gottlieb said in a statement.
"Second, we're requiring additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients' levels of certain inflammatory markers that can be indicators of increased inflammation. This could help us better evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported related to Essure," Gottlieb said.
"The FDA is also requiring Bayer to continue to enroll patients who might still opt to receive Essure in advance of its full discontinuation from the U.S. market, and to continue to submit more frequent reports to the FDA on the study's progress and results," Gottlieb said.
The FDA "will continue its efforts to monitor Essure's safety and effectiveness since its approval in 2002 by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency," Gottlieb said.
Wegmans Recalls Stir-Fry Mixes
Concerns about E. coli contamination have triggered a recall of cauliflower rice and vegetable stir-fry mixes sold at Wegmans stores in six states.
The recall is for fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower sold between Dec. 7 and Dec. 18 at 98 stores in New York, New Jersey, Pennsylvania, Maryland, Virginia and Massachusetts, CBS News reported.
The products have "use by" dates of Dec. 11 through Dec. 22 and include: Wegmans Cauliflower Rice, 1 lb. pkg. UPC #25313500000; Wegmans Cauliflower Rice, 8 oz. pkg. UPC #25307200000; Wegmans Stir Fry Blend (with cauliflower), 1 lb. pkg. UPC #25335800000 and Wegmans Veggie (cauliflower) Rice Blend (sold by the pound), UPC #253162000000.
No illnesses associated with recalled products have been reported, according to Wegmans.
For more information, consumers can call the company at 1-855-934-3663.
The recall was announced five days after a California farm linked with a E. coli outbreak that sickened nearly 60 people recalled cauliflower and red and green lettuce, CBS News reported.
Altria/Juul Partnership Concerns Anti-Tobacco Groups
News that tobacco giant Altria is taking a major stake in Juul, the dominant player in the electronic cigarette market, has anti-tobacco groups worried.
Altria, the parent company for Philip Morris USA, and Juul said their goal is to help smokers switch to safer products, but that claim was met with skepticism by opponents.
"The announcement that Altria is buying a 35 percent stake in Juul is a truly alarming development for public health and brings together the two companies that have been the most successful in marketing their highly addictive products to kids," said Matthew Myers, president of the Campaign for Tobacco-Free Kids, CBS News reported.
"This investment gives the tobacco industry direct access to a new pipeline of millions of youth e-cigarette users, most of whom were not smokers in the first place," Robin Koval, CEO and president of the Truth Initiative, a group that challenges tobacco industry marketing.
"Research shows youth who vape are four times more likely to smoke deadly cigarettes. Given this news, the FDA needs to reconsider the extent and timing of its newly proposed actions to bring this epidemic under control before Juul coupons are on the back of every pack of Marlboro cigarettes and vice versa," Koval said, CBS News reported.
Altria said it will allow Juul products to be sold alongside Marlboro and its other cigarette brands on the company's "premier innovative tobacco products retail shelf space."
Deadly Marburg Virus Found in West African Bats
The deadly Marburg virus -- which is related to the Ebola virus -- has been found for the first time in West Africa, scientists say.
The Marburg virus -- which has a death rate as high as 90 percent in humans -- was found in five Egyptian rousette fruit bats in Sierra Leone, according to the U.S. Centers for Disease Control and Prevention.
No cases of human illness from the Marburg virus have been reported in Sierra Leone, but the fact that the virus has been found in bats means that people nearby could be at risk of infection.
There have been 12 known Marburg virus outbreaks directly linked with Africa. The most recent was in Uganda in 2017. The largest and deadliest Marburg virus outbreak occurred in Angola in 2005, and killed 90 percent of the 252 people who were infected, according to the CDC.
Two of the four strains of Marburg virus found in the bats in Sierra Leone are genetically similar to the strain that caused the Angola outbreak. It's the first time these strains have been detected in bats.
"We have known for a long time that rousette bats, which carry Marburg virus in other parts of Africa, also live in West Africa. So it's not surprising that we'd find the virus in bats there," CDC ecologist Jonathan Towner, who led a CDC team involved in the research, said in an agency news release.
"This discovery is an excellent example of how our work can identify a threat and help us warn people of the risk before they get sick," he added.
The researchers said the bats can carry the Marburg virus without getting sick, and can transmit it to humans or other animals through their saliva, urine, or feces.
© 2020 HealthDay. All rights reserved.
Posted: December 2018
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