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Health Canada Issues Warning Over IVC Filters

As of June 26, there have been 121 serious incidents reported to Health Canada involving inferior vena cava (IVC) filters. It’s a device that closely resembles a spider that is inserted into the largest vein in the body, intended to catch blood clots before they enter the heart and lungs. An IVC filter is often used in a patient that cannot tolerate anticoagulation medications. The device, however, is considered controversial in Canada because of the “serious complications” that have been reported in so many patients, such as the filter migrating, tilting, fracturing or perforating veins and organs. For this reason, hundreds ... Read More

New Ambien safety label warns of severe injury risk

The safety label for the prescription sleep aid Ambien (zolpidem tartrate) has been updated to include a new warning for severe injuries, the Food and Drug Administration (FDA) announced. “Zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries,” the new warning states. “Severe injuries such as hip fractures and intracranial hemorrhage have been reported.” A 2012 study linked the commonly prescribed sleeping pill to a greatly increased risk of falls in hospital patients. The Mayo Clinic study of more than 16,000 hospitalized patients found that the fall rate among ... Read More

Asthma drug linked to serious cardiovascular, cerebrovascular events

The asthma drug Xolair (omalizumab) for children and adults 12 years of age and older can cause problems with the heart and blood vessels supplying the brain, the Food and Drug Administration (FDA) announced after a review of safety studies. As a result, new warnings of an elevated risk of serious cardiovascular and cerebrovascular adverse events will be added to the drug’s label. The review also investigated rates of cancer between patients using Xolar and found no difference compared to patients not being treated with Xolair. However, due to limitations in the five-year study, the agency cannot rule out the ... Read More

Lawsuit against Bayer claims Mirena IUD migrated to rectum

Jennifer Martin was shocked when she learned in September 2012 that she was pregnant. Two months earlier she had gotten a Mirena IUD contraceptive device. An ultrasound confirmed the pregnancy but did not offer any clues as to where the IUD had gone. It was a perplexing mystery, and one that had to be resolved. Shortly after, Jennifer had a miscarriage. A month later, her doctor performed surgery to conduct an extensive search for the IUD among her internal organs, including the liver, spleen and stomach. The intrauterine device was eventually found in her rectum. Bayer Healthcare faces more than ... Read More

Judge orders mediation to resolve Fosamax lawsuits claiming femur fractures

A New Jersey federal judge told Merck & Co. that it is time to settle with plaintiffs in multidistrict litigation over femur fractures allegedly caused by its osteoporosis drug Fosamax. About 900 cases are still pending in the litigation, which stated in 2006. U.S. District Judge Joel A. Pisano ordered Merck and a steering committee representing the plaintiffs to propose a mediator within 30 days, and within five days the parties must provide a written status update regarding the mediation. Merck updated its safety labels in January 2011 to include a warning for potential femur fracture. Barbara Gaynor, whose lawsuit ... Read More

Young adults who were treated with growth hormones as children may be at greater risk for stroke

People who received growth hormones as children to treat short stature or hormone deficiency should be aware that they are at an increased risk of stroke caused by burst blood vessels when they become young adults, a team of French and British researchers say. The warning is based on findings from a study published in this week’s issue of the journal Neurology, and applies also to people who misuse the growth hormones to improve athletic performance, for body building and other “questionable reasons.” Growth hormones were approved in the United States in the mid-1980s to treat pituitary gland problems and to ... Read More

Testosterone therapy poses same safety risks to young men, teenagers

Young men and teenagers hoping to improve in sports are turning to testosterone boosting products, raising concerns about their long-term health. Testosterone replacement therapy is a prescription drug indicated for men whose blood levels show lower than normal levels of the male hormone, resulting in symptoms such as low sex drive, weight gain and fatigue. The treatment can also help build muscle mass, which makes it an attractive supplement to body builders and athletes. Many professional sports have cracked down on the use of performance enhancing drugs, which include testosterone therapy. However, some gyms sell testosterone supplements, says Chad Zimmerman, ... Read More

Fresenius may open new dialysis clinic in Louisiana despite AG’s lawsuit

Fresenius Medical Care, the world’s largest provider of dialysis products and services, is proposing to build a new dialysis center in Terrytown, La., despite being slapped with a lawsuit by the state’s Attorney General earlier this month. Fresenius owns nearly 100 dialysis clinics in Louisiana. The company uses its brand-name products in its facilities and also sells them to non-Fresenius-owned clinics. The state’s lawsuit claims that Fresenius’s dialysis concentrates GranuFlo and NaturaLyte caused patients to suffer from injuries including sudden cardiac arrest, and that the company violated Louisiana law and attempted to defraud dialysis clinics, physicians, the state and its residents by ... Read More

Transvaginal mesh lawsuits continue three years after FDA warning

It has been three years since the Food and Drug Administration (FDA) issued a Safety Communication warning the public that complications with transvaginal mesh used to treat pelvic floor disorders including pelvic organ prolapse and stress urinary incontinence were not uncommon and could be chronic or life threatening. Since then, lawsuits against manufacturers of the devices have grown exponentially. Trasvaginal mesh, also known as vaginal mesh, pelvic mesh, or bladder sling, is a type of surgical mesh that is inserted through the vagina to support organs that have dropped due to age, childbirth, obesity or other conditions. The mesh is ... Read More

Louisiana AG lawsuit claims Fresenius products caused fatal heart attacks in dialysis patients

The Louisiana Attorney General has filed a lawsuit against Fresenius Medical Care North America and the nearly 100 Fresenius-owned dialysis clinics in the state alleging that its dialysis concentrates GranuFlo and NaturaLyte contributed to fatal heart attacks of dialysis patients. The lawsuit, filed in state district court in Baton Rouge, claims Fresenius violated Louisiana law and attempted to defraud dialysis clinics, physicians, the state and its residents with confusing labeling on its dialysis products, which resulted in patients suffering sudden cardiac arrest. Louisiana seeks civil penalties of $5,000 per violation and is asking the court to force Fresenius to pay ... Read More