This month, the manufacturer of medical ventilators for critically ill babies has issued a nationwide recall of thousands of Life Pulse High-Frequency Ventilator Patient Circuits. The high-frequency ventilator is used to treat infants in intensive-care units. The patient circuits, which are made of disposable tubing, provide a conduit for humidification, warming and temperature monitoring of pressurized gas. Bunnell, Inc., the manufacturer, issued the Class I medical device recall notification Dec. 12 after receiving customer complaints that the device has heater…
Injury, Death Hazard Prompts Recall of Ventilator Circuits Used for Babies
A widow in Ohio filed a wrongful death lawsuit in November alleging that her husband’s fatal heart attack during kidney dialysis treatment was caused by Fresenius Medical Care’s failure to provide adequate warnings about the side effects of Granuflo, a dialysis product. As a product liability attorney who is investigating claims of serious and fatal side effects caused by Fresenius dialysis products, the story of Deborah and Charles Swigert is painfully familiar to the stories I hear. The death of…
Federal drug regulators recently approved the first generic version of the Type 2 diabetes drug Actos. But Consumer Reports recommends that people with Type 2 diabetes avoid, if at all possible, the brand name drug Actos as well as the new generic version introduced by Mylan Pharmaceuticals. Consumer Reports’ review of the diabetes drug notes that the active ingredient in Actos and the generic version is associated with serious side effects. According to the Food and Drug Administration, patients who…
Women who take birth control pills and have a hormone disorder called polycystic ovary syndrome have twice the risk of blood clots as other women, according to a new study in the Canadian Medical Association Journal. A blood clot, also called a venous thromboembolism, can be fatal if the blood clot moves to the lungs. The study, published in the December issue of the CMA Journal, was based on analysis of medical and pharmacy information from a sizable health insurance…
The American College of Obstetricians and Gynecologists says that the newest oral contraceptives containing drospirenone, such as Yaz, Yasmin and Ocella, may have a higher risk of causing blood clots than other oral contraceptives. Blood clots can lead to heart attacks and strokes. Federal food and drug regulators have approved for sale two basic types of oral contraceptives—combination pills containing both estrogen and progestin and progestin-only pills. Several of the newer combination contraceptives, including Yaz and Ocella, contain a form…
The latest report by the Institute for Safe Medication Practices raises added concerns about the prevalence of bladder cancer among people taking the diabetes drug Actos. The widely prescribed brand name drug manufactured by Takeda Pharmaceuticals is used to manage blood sugar levels in adults with Type 2 diabetes. The Institute for Safe Medication Practices is a non-profit watchdog group focused on prevention of medication errors and side effects. According the ISMP’s QuarterWatch report, the Food and Drug Administration has…
The diabetes drug Avandia is in the news again because of allegations that the drugmaker GlaxoSmithKline misrepresented the safety of Avandia. GlaxoSmithKline LLC announced a $90 million settlement to resolve allegations that the pharmaceutical company illegally marketed Avandia, according to an article in The Wall Street Journal. The settlement was announced shortly after 38 states, including the state of Illinois, filed claims on November 15 against GlaxoSmithKline LLC for alleged consumer fraud and deceptive marketing. Lawyers with the Illinois Attorney…
Patients undergoing kidney dialysis should not have to wonder whether the medications they are receiving are safe. But an FDA investigation of one of the largest operators of dialysis centers and a major supplier of dialysis products raises serious safety concerns. This year, the FDA issued a Class I recall of dialysis drugs Granuflo and NaturaLyte acid concentrate manufactured by Fresenius Medical Care North America. Class I recalls are the most serious type of product recall. They involve situations in…
People who take the blood thinner warfarin as well as a certain class of antidepressants that includes Zoloft and Paxil may have a higher risk of uncontrolled bleeding, according to a new study presented at the American Heart Association’s annual meeting in early November. Patients taking warfarin and a selective serotonin reuptake inhibitor (SSRI), such as Celexa, Paxil, Prozac and Zoloft, were at a 60 percent higher risk of major hemorrhage compared to warfarin patients who were not taking an…
A new report by the Food and Drug Administration describes a long list of unsafe practices and unsanitary conditions at Ameridose, a drug supplier with some of the same owners as the pharmacy that produced contaminated products linked to a nationwide outbreak of fungal meningitis. Ameridose has been a major supplier of sterile injectable medications to hospitals and sells more than 2,200 blended drug products. The list includes drugs to help women in labor, calm children before surgery, treat severe…
