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Fresenius faces more than 300 wrongful death, injury lawsuits involving GranuFlo, NaturaLyte

More than 300 wrongful death and personal injury lawsuits have been filed against Fresenius Medical Care, the world’s largest provider of dialysis products and services, alleging the company did not adequately warn patients or medical centers about the risk of sudden cardiac arrest with its dialysis products GranuFlo and NaturaLyte. GranuFlo and NaturaLyte are used during dialysis to remove impurities from the blood. Fresenius, which makes the products, uses them in its own dialysis centers as well as distributes them to other dialysis clinics across the country. GranuFlo uses a formulation that the plaintiffs allege causes an unsafe elevation of ... Read More

FDA warns consumers against unapproved diabetes treatments

The Food and Drug Administration (FDA) is warning consumers not to fall for products that claim to prevent, treat and even cure diabetes because they may contain harmful ingredients or be otherwise unsafe. These illegal products can pose an additional risk if they cause consumers to delay or discontinue effective treatments for diabetes. Without proper diabetes management, diabetics are at greater risk for developing serious health complications. The FDA has launched a new initiative to stop the sale of these bogus diabetes products and has issued warning letters to 15 companies to let them know selling these products is in violation of ... Read More

Pepsi vows to reduce amount of cancer-causing chemical in its sodas

Pepsi announced that by 2014 it will reformulate its products sold in the United States to reduce the amount of a cancer-causing chemical called 4-methylimidazole, or 4-MEI. The chemical is used to give caramel coloring to products such as colas, soy sauces, beers, breads and coffees. A 2007 study funded by the National Toxicology Program found that laboratory mice who were constantly exposed to 4-MEI developed lung cancer. The study prompted California last year to ban the chemical in products sold in its state. In response, Pepsi modified beverages sold in California to comply with the new state regulations. Coke ... Read More

FDA warns hospitals to check inventory for stolen, unsterile surgical staples

The Food and Drug Administration (FDA) is notifying all surgical personnel that some surgical staples in their inventory that are labeled as sterile are unsafe because they were stolen from the manufacturer prior to sterilization. The FDA has launched an criminal investigation and is asking health care professionals, especially surgical clinicians, hospital and ambulatory surgery center managers, operating room managers and inventory management personnel to be on the lookout for Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads with the lot number N3B0165LX. The agency is aware that some of these stolen and unsterile products have been offered for sale ... Read More

DePuy engineers knew of problems with metal hip implant but decided not to warn surgeons

An engineer with medical device maker DePuy Orthopaedics, a subsidiary of Johnson & Johnson, warned executives in 2008 that its ASR metal-on-metal hip replacement system is susceptible to releasing extreme metal ions into the bloodstream of patients who had the devices implanted in their bodies, and said that the company needed “to discuss this at the earliest possible opportunity as I believe it means that we need to start any ASR upgrade sooner than our previous plans had suggested.” The DePuy engineer who warned colleagues was Graham Isaac and, despite a memo documenting his concerns about the ASR, Isaac said ... Read More

FDA warns medical facilities about counterfeit Botox

Batches of Botox shipped from a Canadian drug supplier to more than 350 medical facilities in the United States may be counterfeit and unsafe, the Food and Drug Administration (FDA) warned. The drugs were shipped by suppliers owned by Canada Drugs, a pharmacy that was previously found to have shipped unapproved and counterfeit cancer drugs. Botox is prescription medication that is injected into muscles and used to treat overactive bladder, chronic migraines, upper limb spasticity, cervical dystonia, certain types of eye muscle problems or abnormal spasm of the eyelids, and excessive underarm sweating. Botox is also used to temporarily improve ... Read More

FDA warns of counterfeit versions of Adderall

The Food and Drug Administration (FDA) is warning consumers that counterfeit versions of Adderall, used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy, have been sold through the Internet. Adderall is a controlled substance that is only available by prescription. The counterfeit versions of the drug involve the 30 mg dosage. They were found to contain the wrong active ingredients. Adderall contains dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. The counterfeit version of Adderall contains the painkillers tramadol and acetaminophen. Adderall is currently on the FDA’s short supply list because its active ingredients are in short supply. ... Read More

CSPC hesitant to call crib bumper pads unsafe despite death reports

At least 17 cases of infants dying possibly by smothering in the padding of their crib bumper pads were never investigated by the Consumer Product Safety Commission (CSPC) even though the agency had reports on file suggesting the pads contributed to the deaths, according to the Chicago Tribune. Bumper pads are marketed as a must-have crib accessory to parents. The pads circle the inside parameter of the crib to “protect” infants from bumping their heads against the crib’s railing. Parents are usually instructed to remove the pads when babies are able to pull themselves up. Reports show that medical examiners ... Read More