Lucy’s Weight Loss System is voluntarily recalling all lots of Pink Bikini and Shorts on the Beach Blue and Gold Edition capsules distributed from May 25 – June 23, 2015.
Samples of Pink Bikini and Shorts on the Beach tested found positive for the substances sibutramine and phenolphthalein in random Food and Drug Administration (FDA) testing. Continue reading
A lawsuit alleging that Takeda’s Type 2 diabetes drug Actos caused bladder cancer has gone to trial in Las Vegas, Nevada. Judge Jerry Wiese is presiding over the case in the Supreme Court of the State of Nevada. The suit was filed on behalf of two Actos users who were diagnosed with bladder cancer, allegedly due to use of the drug. One of the plaintiffs died of bladder cancer on November 25, 2013; his widow is being represented in the case.
Actos was developed by Takeda and Eli Lilly but is now solely marketed by Takeda in the United States. The drug is used to lower blood sugar in patients with Type 2 diabetes. However, the medication has come under increased scrutiny in recent years after several studies pointed to an increased risk of bladder cancer. In 2011, the U.S. Food and Drug Administration (FDA) warned that use of Actos for one year or longer may increase the risk of bladder cancer. The announcement was issued shortly after the drug was pulled from the market in France and usage was restricted in Germany; these actions were taken because a French study showed that Actos was associated with an increased risk of bladder cancer. Continue reading
General Mills is voluntarily recalling about 1.8 million boxes of gluten-free original and Honey Nut Cheerios because of the possible presence of wheat.
Jim Murphy, senior vice president of General Mills’ cereal division, said he was “embarrassed and truly sorry” for an incident that allowed wheat flour to be introduced into the gluten-free oat flour system at a production facility in Lodi, California, the Washington Post reports. Continue reading
The U.S. Food and Drug Administration (FDA) is ordering duodenoscope manufacturers to study how the devices are cleaned. The safety studies are prompted by a series of antibiotic-resistant bacterial infection outbreaks in the United States linked to contaminated scopes. The makers of the specialized gastrointestinal scopes, which are all based in Japan and have affiliates in the United States, are Olympus American, Fuji Medical Systems and Hoya Corp., LA Times reports.
The scope makers must submit plans to study how well hospital staff are complying to instructions for cleaning and disinfecting the devices in between uses. The FDA’s goal is for these studies to shed light on the superbug outbreaks. This year, there were two outbreaks linked to duodenoscopes at Los Angeles hospitals. Officials from both hospitals say the scopes were cleaned according to manufacturers’ instructions. Continue reading
In a safety alert issued on October 5, the Food and Drug Administration (FDA) noted recent reports of reduced leaflet motion in some bioprosthetic aortic valves, including both SAVR (surgical aortic valve replacement) and TAVR (transaortic valve replacement) devices.
Most cases of reduced leaflet motion were discovered by advanced imaging studies in patients without symptoms of abnormal bioprosthetic valve function. Further, these studies have shown that in valves with reduced motion of one or more individual leaflets, there was acceptable forward blood flow through the valve opening without evidence of stenosis (narrowing), according to the FDA. Continue reading
Rabbi Sholom Doyber Levitansky was arrested by Santa Monica, California police last week on felony charges of sexual abuse of a child.
The police are seeking further information and are trying to locate any additional victims, the Santa Monica Daily Press (SMDP) reports. Continue reading
California Parents Sue GlaxoSmithKline over Child’s Heart Defect Allegedly Caused by Zofran Taken During Pregnancy
Alameda County, California, parents have filed a lawsuit against GlaxoSmithKline (GSK) for a heart defect their daughter suffered allegedly as a result of the mother being prescribed Zofran (ondansetron) while pregnant.
This medication is used to prevent nausea and vomiting caused by chemotherapy and radiation therapy and is also used to prevent and treat nausea and vomiting after surgery. It works by blocking one of the body’s natural substances (serotonin) that causes vomiting, according to WebMD. Continue reading
A bicycle recall is being issued due to a problem with front wheel disc brakes. According to the U.S. Consumer Product Safety Commission, the recall involves 13 manufacturers and affects 1.3 million bikes. Popular brands such as Giant, Cannondale and Specialized are affected by the recall. The CPSC advises consumers to “stop using the bicycles immediately and contact the recalling company for free installation of a new quick release on the front wheel,”
The issue involves the open quick release lever on the bicycle’s front wheel hub, which can catch onto the front disc brake rotor; this may cause the front wheel to stop or separate from the bike and injure the rider. The CPSC says three incidents have been reported, including one injury. The recalled bikes were sold from 1998 to this year. Roughly 1.3 million units were sold in American and over 250,000 were sold in Canada and Mexico. Continue reading
Automaker Fiat Chrysler under-reported a “significant” number of deaths, injuries and legal claims that it was obliged to reveal to regulators, according to the National Highway Traffic Safety Administration (NHTSA).
The federal regulator announced the under-reporting after Fiat Chrysler said it had discovered “deficiencies” in its system for reporting defects under the Tread Act, a law that specifies the information car makers must submit to regulators, CNBC reports. Continue reading
Health Canada, Canada’s health regulatory agency, has updated the label information for the multiple sclerosis drug Gilenya (fingolimod) to include stronger safety warnings on the risk of skin cancer and the rare brain infection progressive multifocal leukoencephalopathy (PML), which can be fatal.
Gilenya, a prescription drug, is used in the treatment of relapsing-remitting multiple sclerosis (MS) to reduce the frequency of attacks (relapses) and delay the progression of physical disability. Gilenya is used specifically when other MS treatments have not been effective or cannot be tolerated, Health Canada explains. Continue reading