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Label Check: Infant Acetaminophen


  The recent introduction of a less-concentrated version of liquid acetaminophen for infants has prompted the U.S. Food and Drug Administration to suggest that parents and caregivers double-check the labels on all liquid acetaminophen products prior to administering any to their child.   While the newer, less-concentrated form of the pain reliever (160 milligram per 5 milliliter) has started to arrive on pharmacy shelves, many people may have the more concentrated, original version (80 milligram per 1 milliliter) at home...

French Breast Implant Manufacturer, PIP, Faces Mounting Scrutiny Over Product Safety Concerns


  In May of 2000, the U.S. Food and Drug Administration sent an agency investigator to France in order to inspect a plant run by breast implant manufacturer, Poly Implant Prothese (PIP). Following the completion of its inspection, U.S. health authorities issued a warning letter to PIP’s founder, outlining concerns that the company’s implants were “adulterated.” The FDA’s letter also cited at least 11 manufacturing infractions at the company’s plant in southeastern France.   Last week, French health regulators recommended...

FDA Investigates Safety of Boston Scientific’s New Heart Stent


  The U.S. Food and Drug Administration last month approved Boston Scientific’s Promus Element Heart Stent, a tiny tubular device designed to open diseased arteries. Interestingly, the agency issued its approval of the device, even after receiving reports that the stent could potentially become deformed after it is implanted.   The problem, officially known as longitudinal stent deformation, also occurs in similar devices manufactured by competitors like Medtronic and Abbott Labs, but the largest number of reported issues are linked...

FDA Requires Multaq Label to Carry Ischemic Event Warning


  The U.S. Food and Drug Administration has ordered drug maker, Sanofi-Aventis, to revise the label of its anti arrhythmic medication, Multaq (dronedarone), in order to more accurately reflect its increased risk of death or serious cardiovascular events when taken by patients experiencing permanent atrial fibrillation. Multaq has been approved by the FDA to treat atrial flutter and paroxysmal or persistent atrial fibrillation, but not permanent Afib.   Data presented at a recent meeting of the American Heart Association confirmed...

New Study Reveals Canned Soup May Cause Exposure to BPA


  For many, a bowl of hot soup is often a go-to, daily meal of choice. However, alarming new research from the Harvard School of Public Health (HSPH) suggests that our favorite can of soup may actually contain far more than just the usual amount of beef and vegetables.   Given the results of an HSPH study, researchers now contend that canned soup contains a generous dose of bisphenol A (BPA), a chemical that may cause reproductive problems in humans....

The Importance of Early Diagnosis for Patients with Faulty All-Metal Hip Implants


  More than ten years after researchers began to warn that metal-on-metal hip implants could shed tiny pieces of metallic debris into the bloodstream, the devices have become the subject of one of the country’s largest medical device failures, fueling a public health problem that continues to plague both doctors and patients.   An interesting article published in the New York Times tells the story of a female patient who learned that the artificial hip she received in 2007 was...

Four Drugs Found to Cause Most Adverse Event Related Emergency Hospitalizations for Seniors


A study published in the November 24th issue of the New England Journal of Medicine has pinpointed four drugs and drug classes that account for nearly two-thirds of the estimated 100,000 adverse event-related emergency room visits for seniors each year. The data for the study was collected from 58 hospitals participating in an ADE surveillance project, beginning in 2007 and ending in 2009. Specifically, the study’s main researchers, all from the U.S. Centers for Disease Control and Prevention, identified the...

Federal Regulators Announce Merck Will Pay $950 Million to Resolve Vioxx Investigations


This week, the U.S. Justice Department announced that drug maker, Merck, will pay a staggering $950 million to resolve investigations into the illegal marketing practices of its popular painkiller, Vioxx. Specifically, Merck will pay $321.6 million in criminal fines and $628.4 million as part of the civil settlement. The company will also plead guilty to charges of marketing Vioxx as a treatment for rheumatoid arthritis prior to receiving approval to do so from the U.S. Food and Drug Administration. In...

I Think Actos Gave Me Bladder Cancer — What Now?


Following reports that taking the popular diabetes drug, Actos, could increase a patient’s risk of developing bladder cancer, many current and past users of the drug are now concerned about their health. For these individuals, it is first important to understand the symptoms of bladder cancer, as well as to learn the proper steps one must take, should these symptoms indeed occur. The most common signs of bladder cancer include blood in the urine, changes in the color of your...

Merck Agrees to Settle Consolidated Vioxx Claims in NY, FL and SC


According to a November 10th court filing, pharmaceutical company, Merck & Co., has agreed to settle Vioxx lawsuits in the states of New York, Florida and South Carolina. The company previously paid $4.85 billion in order to resolve more than 27,000 lawsuits that claimed their pain killer, Vioxx, caused patients to suffer heart attacks. Prosecutors also alleged that the company misled state officials regarding the drug’s overall safety and health risks. Vioxx was pulled from the market in 2004, after...


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