The U.S. Food and Drug Administration (FDA) has warned St. Jude Medical to address safety issues concerning the company’s Durata heart device – an electrical lead wire that connects an implanted defibrillator to a patient’s heart. This implantable cardioverter defibrillator (ICD) lead may fail by not sufficiently preventing insulation abrasions that can cause patients to experience debilitating shocks and even die. St. Jude Looking At Fines & Penalties According to a recent article in the New York Times, the FDA… Read More
Category: <span>News</span>
Proctor & Gamble’s Actonel, a class of bisphosphonates used to treat osteoporosis, has been linked to many serious side effects – including Osteonecrosis of the Jaw (ONJ) or jaw death. A recent Actonel jaw death victim has filed a $1.5 million product liability lawsuit against Proctor & Gamble for his injuries. Like so many other victims, he wants to know why the pharmaceutical giant failed to warn him of known dangers. Actonel ONJ Lawsuit According to a recent article published… Read More
Billions of dollars are spent every year on drug research – the results of which get published in medical journals and are relied upon by doctors and patients across the nation. However, most people don’t know that a great deal of what gets published is actually written by the drug industry itself or by doctors, scientists and researchers who are paid by drug companies. That begs the question – can drug industry research really be unbiased? Case In Point: Avandia… Read More
The U.S. Food & Drug Administration announced that it has placed a black box warning on Incivek, a hepatitis-C drug generally used by liver disease patients. Manufactured by Vertex Pharmaceuticals, the drug has been linked to serious rash conditions including Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) – all of which can lead to serious injury or death. Incivek Black Box Warning The FDA issued an Incivek black box warning on… Read More
The U.S. Food & Drug Administration and Medtronic Neuromodulation, the Minnesota-based medical device giant, issued a Class I recall of the company’s SynchroMed II Implantable and SynchroMed EL Implantable Infusion pumps due to motor stalling and drug dispensing issues which could result in serious adverse health risks or death. Medtronic Drug Infusion Pump Recall & Follow Up In November, the FDA issued a Class I recall on the Medtronic SynchroMed II Implantable Drug Infusion Pump and the SynchroMed EL Implantable… Read More
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… Read More
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… Read More
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… Read More
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… Read More
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… Read More
