Posts made in May, 2013


Have You Used GranuFlo?

Have You Used GranuFlo?


Posted By on May 28, 2013

GranuFloGranuFlo is an acid concentrate used during hemodialysis treatment to neutralize the buildup of acid in the blood. GranuFlo is known as a dry acid. In March of 2012, the FDA issued a Class 1 recall of this treatment based on reports of serious side effects and death.  If you have undergone dialysis treatment in the last few years, request a copy of your medical records to determine if this particular drug was used during your treatment.

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Is Yaz Still Being Sold?

Is Yaz Still Being Sold?


Posted By on May 27, 2013

yaz injuriesYaz, America’s top-selling birth control, hit the shelves in 2006 in a big way.  The pill promised effective birth control, clearer skin, and the ad campaign reflected that Yaz was hip, young, and definitely not the same birth control your mother grew up on.  Claims against the dangerous drug were already taking place overseas, in places like Great Britain, but in America the birth control pill kept selling, despite some of the health warnings.  The too-good-to-be-true pill started showing its true colors.  Even with FDA warnings and an amended commercial, Yaz kept selling and women kept feeling the pain of side effects.

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In March 2012, the FDA issued a Class 1 recall notice for Granuflo (dry) and Naturalyte (liquid) acid concentrates due to the risk that improper mixtures of the products could contribute to a high serum bicarbonate level in hemodialysis patients and trigger metabolic alkolosis. This concentrate was manufactured and distributed from January 2008 through June 2012. A Class 1 recall is the most serious kind. It involves situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or even death.

GranuFlo is an experimental drug designed to facilitate kidney dialysis. Medical researchers learned that GranuFlo’s primary ingredient converted to bicarbonate during dialysis. Bicarbonate is a class of naturally-occurring salts, in the same chemical tree as baking soda (bicarbonate of soda). It is critical to dialysis because it neutralizes the body’s pH level, or acidity, helps kidneys function more fully and regulates the body’s acid/base balance.

Thus, while bicarbonate is essential to dialysis’s goal and health in general, too much can cause serious problems. Physicians, who did not know that GranuFlo converted to bicarbonate, sometimes gave patients too much, resulting in unexpected cardiac complications.

The graphic contains information from the U.S. Food and Drug Administration (FDA) and other sources. It provides details concerning the Class I recall notice that has been issued for these products as well as information concerning the risk of metabolic alkalosis. This is for educational purposes only.

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Mirena – Infographic

Mirena – Infographic


Posted By on May 11, 2013


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What is Mirena?

Mirena is a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The female hormone released by the device, levonorgestrel, thickens the cervical mucus to prevent sperm from reaching or fertilizing the egg.

The U.S. Food and Drug Administration (FDA) approved Mirena for use as a contraceptive in 2000 and for use in treating heavy menstrual bleeding in IUD users in 2009.

The FDA’s Division of Drug Marketing, Advertisin and Communications (DDMAC< now known as the Office of Prescription Drug Promotion), sent warning letters to Bayer in 2009, alleging that Bayer was:

  • Overstating Mirena’s effectiveness
  • Sponsoring misleading online links
  • Downplaying the serious health risks associated with Mirena usage
  • Failing to communicate risks information to women and doctors

The graphic contains information from the U.S. Food and Drug Administration (FDA) and other sources, including AdverseEvents.com, which tracks adverse events reports to the FDA.

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