News Tagged ‘lawyer’
FDA warns food companies to change ‘misleading’ labels
Several food products on store shelves have misleading labels that violate federal law, and the Food and Drug Administration (FDA) is warning companies to change those labels within 15 days or the agency will pull those products from grocery store shelves. The FDA sent warning letters to 17 different food makers last week demanding swift compliance.
father and son hit the road to raise brain injury awareness
When Joshua Brantner was 20 years old, he attended a party that changed his life forever. He arrived as a healthy, ordinary guy but left in an ambulance with a traumatic brain injury that severely impaired his mental and physical functions.
NHTSA wants more states to ban texting while driving
The National Highway Traffic Safety Administration has developed a legal template that will help states develop legislation banning the act of texting behind the wheel. The sample law is modeled after the Executive Order issued by President Obama in October of last year that prohibited federal employees from texting while driving.
March is brain injury awareness month, concussions take spotlight
March is Brain Injury Awareness Month, and this year the Brain Injury Association of America (BIAA) is calling attention to concussions, which are often overlooked, ignored, or not taken seriously. To help boost awareness of concussions and the threats they pose, especially to children and adolescents, the BIAA is launching a year-long education and advocacy campaign called under the banner “A concussion is a brain injury. Get the facts.”
Recall due to risk of injury, exposure to infectious micro-organisms
The Food and Drug Administration (FDA) has issued a Class 1 recall on a machine used in research laboratories because it may break, causing the potential for serious physical injury to bystanders and may expose them to blood-borne infectious micro-organisms. A Class 1 recall is the most serious type of recall the FDA can issue and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Combined HIV treatment may cause serious side effects of the heart
The Food and Drug Administration (FDA) is warning health care professionals and patients about a potentially serious side effect on the heart from use of two antiviral medications when given together to treat HIV infection. The warning is based on preliminary data from a clinical trial that suggests that Invirase (saquinavir) in combination with Norvir (ritonavir) may cause prolongation of the QT and PR intervals on an electrocardiogram. This prolongation may lead to abnormal heart rhythms such as torsades de pointes and heart block. These conditions may cause lightheadedness, fainting, or abnormal heart beats. In some cases, torsades de pointes may progress to a life-threatening irregular heat beat known as ventricular fibrillation.
18-wheeler causes multi-vehicle pile-up in Virginia
The operator of an 18-wheel semi truck has been cited for reckless driving after causing a multi-vehicle traffic accident in Virginia on Monday. According to authorities in Carroll County, Virginia, 46-year-old Marco Tulio Carta Jena of Morgantown, North Carolina, crashed his rig into other vehicles that had become backed up along I-77 as another accident further up the interstate was being cleared. Investigators say that the driver was not paying attention to the road when he collided with the other vehicles.
FDA places black box warning on Exjade
Exjade (deferasirox), a treatment for chronic iron overload due to blood transfusions for adults and children age 2 years and older, now has an Food and Drug Administration (FDA) black box warning alerting health care professionals and consumers of a risk of serious complications that may lead to death. A black box warning is the strongest form of warning issued by the FDA and is placed on drugs that have potentially harmful or deadly side effects. As a result of the FDA warning, new language was added to the drug’s Contraindications, Warnings and Precautions, and Drug Interactions sections of its packaging. The labeling states that the product may cause renal impairment, including failure; hepatic impairment, including failure; and gastrointestinal hemorrhage. The warning affects Exjade Tablets for Oral Suspension.
FDA warns consumers against using ear candles
Burning ear candles that manufacturers claim draw ear wax and “impurities” or “toxins” out of the ear canal should not be used because they may cause serious injury even if used according to manufacturers’ instructions, according to a warning from the Food and Drug Administration (FDA). Ear candles are hollow cones about 10 inches long and made from a fabric tube soaked in beeswax, paraffin or a mixture of the two. In ear candling, also called ear coning or thermal auricular therapy, a patient lies on his side while a candle is placed in the outer ear and lit.
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