Pharmaceutical

FDA investigates makers of dialysis treatment linked to hundreds of sudden deaths

fda logo FDA investigates makers of dialysis treatment linked to hundreds of sudden deathsThe nation’s largest operator of dialysis centers is under investigation by the Food and Drug Administration (FDA) for failing to warn patients that use of one of their products could be deadly.

Fresenius Medical Care treats more than 130,000 of the estimated 400,000 Americans who receive dialysis. The company also is the leading supplier of dialysis machines and disposable products to other dialysis clinics across the country.

Last November, the company’s medical office sent an internal memo to doctors at its clinics warning that improper use of one of its products could be the cause of a stark increase in the number of patients dying suddenly from cardiac arrest. The company failed to notify patients of this potential danger, nor did it inform the FDA as is required by law.

According to the memo, 941 hemodialysis patients experienced cardiac arrest from 667 Fresenius facilities in 2010. Fresenius compared these patients to more than 800,000 other dialysis patients in the same center and identified the problem as being an excess of bicarbonate, or alkalosis, a protein that is linked to a six-fold increase for cardiopulmonary arrest.

The internal memo Fresenius sent to its doctors never told them that the product in question was GranuFlo, until March, when the FDA received an anonymous copy of the memo. GranuFlo, a dry acid product used in dialysis treatment, is associated with higher bicarbonate levels than competitor products. Apparently, doctors had not been informed that elevated bicarbonate can result with GranuFlo, and thus were not taking this into consideration when dosing. This overdose of bicarbonate could lead to heart problems.

In March, after the FDA questioned Fresenius about the internal memo, the company notified its patients. That letter did not inform patients, however, of the 941 cardiac arrest deaths that had occurred at its clinics in 2010.

In March, the FDA ordered a Class 1 recall on Fresenius’ GranuFlo and NaturaLyte, a similar dry acid concentrate. A Class 1 recall is the most severe recall the FDA can issue and is reserved for products in which there is a reasonable probability that use or exposure to the product will cause serious adverse health consequences or death.

The recall required Fresenius to take extra measures to inform doctors at its centers and other clinics of dosing errors with its products, and to change its product labels.

Any problems following use of GranuFlo or NaturaLyte during dialysis treatment should be reported to the FDA Medwatch Adverse Event Reporting program at www.FDA.gov/MedWatch/Report.htm.

Sources:
NY Times
FDA
Fresenius Medical Care