Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Warns Americans Not to Buy Drugs From Canadian Company
A large Canadian drug distributor sells unapproved and mislabeled medicines to Americans, the U.S. Food and Drug Administration warned Thursday. The distributor disputes the claim, however.
CanaRx sells common prescription medicines at a lower cost to hundreds of public and private employer programs in the United States, including city and county governments trying to save money, The New York Times reported.
The company says it provides high-quality medications from Canada, Australia and Britain, but the FDA says that’s not always the case.
“Operations like CanaRx use their names to imply that patients are receiving medicines approved in Canada, when it’s likely that some of those drugs are from other countries with lax standards,” FDA Commissioner Dr. Scott Gottlieb told the Times.
“Such operations take advantage of unsuspecting Americans, by purporting to distribute safe and effective imported drugs, at least some of which are instead expired, mislabeled, subject to recalls or potentially counterfeit,” Gottlieb said.
A statement on the FDA’s website urges consumers not to use any medicines obtained from CanaRx, but the agency does not offer any evidence that medicines sold by CanaRx come from countries other than those advertised, the Times reported.
“Every prescription that is dispensed through a CanaRx program is dispensed directly to the patient from a licensed, regulated, brick-and-mortar pharmacy in Canada, Britain or Australia, and the patient can be sure that medicine she receives is the medicine that her doctor ordered,” Joseph Morris, general counsel for CanaRx, told the Times.
Morris said the company would cooperate with the FDA, but added that “many of the websites listed in the FDA letter belong to other entities completely unconnected to CanaRx.”
Of the websites listed in the letter, 123 were active CanaRx websites; 27 were CanaRx programs that have been terminated, and 15 were not affiliated with the company, Morris told the Times.
An FDA spokesman told the newspaper that the agency stood by its findings.
NYC Measles Outbreak Cases Reach 121
The number of measles cases in the New York City outbreak that began last October in the Orthodox Jewish community has reached 121, the city’s health department said Thursday.
Most of the cases (108) are in children younger than 18, with 13 cases in adults. No deaths have occurred, but eight people have been hospitalized and one child ended up in the intensive care unit.
Of the 121 cases, five were diagnosed in the past week and 26 were identified after symptoms subsided. Most of the cases have occurred in Borough Park and Williamsburg, Brooklyn, according to the city’s Department of Health and Mental Hygiene.
Four cases, including the first one, were acquired on visits to Israel, where there is a large measles outbreak. One case was acquired in the U.K. and one in the Ukraine.
Measles is highly infectious and can cause pneumonia, encephalitis (swelling of the brain) and death. Measles is preventable with the measles-mumps-rubella (MMR) vaccine.
A city health department-led campaign to encourage vaccination has led to more than 7,000 people receiving the MMR vaccine.
“As a pediatrician, I can’t stress enough how critical it is to vaccinate children against measles,” Health Commissioner Dr. Oxiris Barbot said in a city news release. “Measles is a serious, highly contagious and potentially deadly infection. Complications and fatalities are rare but do happen. I urge parents not to take any risks that may jeopardize their children or other children in their community.”
Pop Warner Bans Three-Point Stance in Youngest Divisions
The traditional three-point stance has been banned in the youngest divisions of the Pop Warner youth football league.
The new policy takes effect in the 2019 season and affects Tiny Mite (5 to 7), Mitey Mite (7 to 9) and Junior Pee Wee (8 to 10). This is the first national football organization to eliminate the three-point stance, CNN reported.
Players in those divisions will no longer place their hands on the ground when they line up for the ball snap. This stance is being banned because it lowers players’ heads, putting them at greater risk for head injury.
When players line up for the snap, they’ll have to be upright or in a squat position with their hands on their legs, CNN reported.
Pop Warner plans to eventually ban the three-point stance in all its divisions, but there is no firm date on that.
Pop Warner will also eliminate the kickoff in its Pee Wee (9 to 11) division in the upcoming season, after banning it in the three youngest divisions in 2016. After a score or when starting a half, the ball is placed at the 35 yard line, CNN reported.
There is a risk of head injury during kickoff because players run and tackle at particularly high speeds.
Flu Shots Don’t Cause Miscarriages: Study
A flu shot cannot cause a pregnant woman to miscarry, researchers say.
“This is a very definitive study for a recent, relevant time period of flu and should remove all doubts a woman might have about whether it is safe to be vaccinated during pregnancy,” said co-investigator Dr. Edward Belongia, director of the Center for Clinical Epidemiology and Population Health at the Marshfield Clinic Research Institute in Wisconsin, CNN reported.
The findings are based on an examination of the 2012-13, 2013-14 and 2014-15 flu seasons and were presented Wednesday to the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
The study comes a time when there is significant focus in the U.S. on the consequences of certain groups telling people to ignore vaccine recommendations, CNN reported.
Not only is a flu shot during pregnancy safe, it’s necessary, said lead investigator James Donahue, a senior epidemiologist at Marshfield.
“There’s lots of evidence of the severity of flu for a pregnant woman, more chance of hospitalization, more risk of death, especially as she enters the second and third trimester,” Donahue said, CNN reported.
“There are also many studies that show the mother’s vaccination will help protect the newborn baby from flu, which is critical since the baby cannot be vaccinated until 6 months of age,” he added.
CDC guidelines emphasize the importance of a flu shot during pregnancy.
“The findings provide a high level of reassurance regarding the safety of influenza vaccine in early pregnancy and through pregnancy and support the current recommendations of an influenza vaccination for all pregnant women,” Donahue said, CNN reported.
Robotically-Assisted Surgical Devices Not Approved for Cancer Surgery: FDA
The use of robotically-assisted surgical devices for breast removal and other cancer-related surgeries is not approved by the U.S. Food and Drug Administration because there is no proof of its safety or effectiveness in such cases, the agency says in a warning to doctors and patients.
“Certain patients with cancer may require surgical procedures to treat or prevent the spread of cancer in their body. These procedures are often associated with improved survival outcomes for these patients,” Dr. Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in an agency news release.
“However, today we are warning patients and providers that the use of robotically-assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency, and therefore the survival benefits to patients when compared to traditional surgery have not been established,” Cornelison said.
Robotically-assisted surgical devices are used to perform a variety of surgical procedures through small incisions, and this type of surgery may help reduce pain, blood loss, scarring, infection and recovery time.
But in “the case of robotically-assisted surgical devices and cancer-related uses such as mastectomy (breast removal), we are aware of scientific literature reporting that surgeons have been using the device for uses not granted marketing authorization by the FDA,” Cornelison said.
“We want doctors and patients to be aware of the lack of evidence of safety and effectiveness for these uses so they can make better informed decisions about their cancer treatment and care.”
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Posted: March 2019