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FDA Investigates Fresenius for Failure to Warn of GranuFlo Risks

Published on Apr 2, 2013 at 8:36 am in Dangerous Drugs.

The U.S. Food and Drug Administration (FDA) recently launched an investigation into Fresenius Medical Care, the nation’s largest provider of dialysis services to kidney patients. The investigation focuses on whether Fresenius failed to adequately warn doctors and patients of the risk of cardiac arrest and other serious medical conditions linked to the use of two of its dialysate products, GranuFlo and NaturaLyte.

In November 2011, Fresenius sent a memo to the doctors treating kidney patients in the company’s own medical centers.  In the memo, the company warned that doctors should check a patient’s bicarbonate prescriptions before using GranuFlo or NaturaLyte during that patient’s dialysis treatment. GranuFlo and NaturaLyte both contain compounds that convert to bicarbonate in the blood.  If a patient receives too much bicarbonate, a fatal heart attack or other life-threatening medical condition can occur.

Although Fresenius notified its own clinics in November, it did not send notice to other clinics that also use GranuFlo or NaturaLyte to treat their patients. The company only notified other providers in March 2012, and it only did so after the FDA questioned the company about the November memo, which it received anonymously.  The FDA also questions whether the notice to the doctors was adequate or whether the company should have taken steps to warn patients more directly.

Kidney patients face many uphill battles when it comes to managing their conditions, but fear of serious injuries caused by their treatment should not be one of them. An experienced Kentucky defective drug attorney can help you understand your legal rights.

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Tad Thomas has dedicated his practice to representing plaintiffs in various types of civil litigation, including personal injury, business litigation, class actions, and multi-district litigation.

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