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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.
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.
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.
A class of asthma drugs known as Long-Acting Beta Agonists (LABAs) should never be used alone, warns the Food and Drug Administration (FDA), and manufacturers of these drugs will now be required to include this warning in the labels of their drugs as well as steps on how to reduce overall use of the products. The warning is based on FDA analysis of clinical trials of LABAs that show the drugs are associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults, and death in some patients with asthma.
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.
The Food and Drug Administration is updating health care professionals about a medication used to treat patients with relapsing forms of multiple sclerosis (MS) and moderately to severely active Crohn’s disease. New safety information indicates that the risk of developing a rare but life-threatening brain infection known as progressive multifocal leukoencephalopathy (PML) increases with the number of infusions received of Tysabri (natalizumab). The announcement updates a September 2009 warning about PML associated with use of the Tysabri.
Cleocin HCL (clindamycin hydrochloride) capsules, an antibiotic used to treat serious infections caused by bacteria, has received a new black box warning about the risk of Clostridium difficile (C. difficile) associated diarrhea (CDAD) that may range in severity from mild diarrhea to fatal colitis, according to the Food and Drug Administration (FDA). CDAD has been reported with use of nearly all antibacterial agents, including Cleocin HCL. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. Clostridium difficile.
Tekturna (aliskiren) tablets, a prescription medication used to treat high blood pressure, has updated its safety label to include a new black box warning about the risk of injury and death to developing fetuses when taken by women who are pregnant or become pregnant, according to the Food and Drug Administration (FDA).
At least 250 people – 50 more than previously identified – have been exposed to excess radiation of up to eight times the expected level during CT perfusion scans, causing hair loss and skin redness, and putting them at risk of some forms of cancer, according to Food and Drug Administration (FDA) safety investigation.
The Food and Drug Administration (FDA) is warning hospital risk managers, surgical service managers and infection control professionals that a device used in surgical and endoscopy suites for sterilizing or disinfecting medical devices has been modified, has not been approved by the FDA, and may not properly disinfect or sterilize instruments, which may pose a serious risk to patients and health care staff.
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