Following reports of skin irritation and burns, McDonald’s is recalling 29 million “Step It!” fitness trackers included in some Happy Meals. According to a statement from the U.S. Consumer Product Safety Commission, McDonald’s received more than 70 reports of adverse events associated with the fitness bands, including seven reports of blisters.
Last week, the fast-food giant pulled the wristbands from stores in the United States and Canada. Company spokesperson Terri Hickey told USA Today said the wristbands are no longer being offered with Happy Meals. “We have taken this swift and voluntary step after receiving limited reports of potential skin irritations that may be associated with wearing the band,” she said in a statement. Continue reading
Medical device manufacturers are required to report any event that “reasonably suggests a device may have caused or contributed to a death or serious injury.” Madris Tomes, a former FDA consultant, conducted an analysis showing that 4,000 patient deaths were labeled as “injuries” or “malfunctions” between 2011 and 2015. She says these labels are important because they help determine which issues are priorities for public health analysts.
When a death gets categorized as an “injury” or “malfunction”, it delays reviews of that issue. “The way that the FDA reviews the [safety] reports is in order of importance by the classification that is checked on the form,” Tomes said, according to NBC. “So if it is an injury or malfunction, it could take them weeks to months to get to reading them.” Continue reading
A deadly crash over the weekend leaves six people dead and another five injured on Long Island. Authorities say a speeding SUV caused the crash when it came up fast on a work zone on the Long Island Expressway. The driver of the vehicle, a Subaru Outback, reportedly swerved to avoid the slowed traffic and collided with cars on the opposite side.
Several witnesses say the Subaru was speeding before it swerved and hurdled across the grassy median, according to Suffolk police Chief of Detectives Gerard Gigante. The car became airborne and slammed into two cars, a BMW and a Honda, heading west. The crash killed the 26-year-old driver of the Subaru, along with his 27-year-old sister and 10-year-old son. Continue reading
The fluoroquinolone antibiotic Cipro (ciprofloxacin) is one the medications linked to the extreme allergic reaction Stevens-Johnson syndrome (SJS).
Though Stevens-Johnson is not common, it can be fatal if not treated quickly, according to Top Class Actions. Continue reading
Cambridge Farms, LLC of Lancaster, Pennsylvania has recalled three brands of frozen corn products because they may be contaminated with listeria monocytogenes. The organism can cause serious and sometimes fatal infections in young children, the elderly and people with weakened immune systems.
To date, no illnesses have been reported, according to the recall notice. Continue reading
More than 5,400 individuals including first responders along with residents or employees who worked in the vicinity of the World Trade Center (WTC), have been diagnosed with 9/11-linked cancers. The medical director, Dr. Michael Crane, of the WTC Health Program at Mount Sinai Hospital, remarked of the alarming increase in numbers that have tripled in the past 2½ years.
Dr. Crane stated that new patients are being identified for the last year and a half with cancer, 10 to 15 times a week, every week. As of June 30, 2016, 5,441 patients have enrolled in the program with 6,378 separate cancers, an increase of 1,822 victims from January 2014. Continue reading
Laxachem manufactures active pharmaceutical ingredients (API) for repackers, labelers, and wholesale drug distributors, some of which do business with manufacturing facilities in the United States. One of the drugs Laxachem manufactures is Docusate Sodium USP, a stool softener that is often prescribed by doctors for the treatment of bowel movement problems.
On August 11, 2016, the U.S. Food and Drug Administration (FDA) placed Laxachem Organics Pvt. Ltd., Ahmednagar, from Maharashtra, India on import alert after the company had refused FDA investigators access to their facility for inspection. This lack of cooperation led the agency to halt all Laxachem pharmaceutical products from entering the United States legally. Continue reading
An 11-year-old girl suffered hair loss and went nearly bald after using Wen cleansing conditioner, but she isn’t the only one. More than 21,000 complaints have been filed over celebrity hairstylist Chaz Dean’s line of Wen hair products alleging hair loss, hair breakage and other issues. In the young girl’s case, she noticed large bald spots after using Wen cleansing conditioner three times.
Her hair continued to fall out even after she stopped using the product, leaving her nearly bald. Her mother says her hair is still not back to its former state, Inquisitr reports. They have joined 200 other consumers in a class action lawsuit against Wen creator Chaz Dean. The little girl says she was teased relentlessly by her peers at school, and eventually homeschooled. When she lost her hair, the girl said she was worried that she may have cancer or another serious medical condition. Continue reading
People who had a beverage at Trento, a restaurant in East Farmingdale, New York, in mid- to late July may have been exposed to hepatitis A.
The Suffolk County Health Services Department said people who were exposed may be eligible for free treatment, Newsday reports. Continue reading
Compared to drugs and medical devices, there are few regulations in place to assure the safety of a cosmetic product. A new bill, introduced by senators Dianne Feinstein (D-CA) and Susan Collins (R-ME), seeks change. The proposed legislation would require the U.S. Food and Drug Administration (FDA) to assess the safety of at least 5 chemicals used in cosmetics every year. Those reviews would be financed by collecting fees from the industry. Additionally, the bill would give the FDA authority to mandate a recall, demand safety data from companies and order them to report any health complaints from customers.
There have been instances where the safety of a cosmetic product has been called into question. Wen Hair Care products, for instance, has received more than 21,000 complaints of itching, rashes and hair loss. The Occupational Safety and Health Administration (OSHA) has found that some hair straightening products contain formaldehyde, a known carcinogen that has been linked to allergic reactions, hair loss, rashes, blisters and other issues. Continue reading