Medical Description

The end result of many renal diseases, End-Stage Renal Disease (ESRD) is a complete or near complete failure of the kidneys to function to excrete wastes, concentrate urine, and regulate electrolytes.

This condition is associated with chronic renal failure. The kidneys of a patient with ESRD show continually increasing levels of blood urea nitrogen (BUN) and serum creatinine, toxic substances that would be execreted in the urine of a healthy patient. Chronic renal failure can be treated by dialysis or by kidney transplantation.

ESRD is sometimes called chronic kidney failure or Stage 5 Renal Failure. Stage 5 refers to the final stage of decline in kidney GFR, or kidney glomerular filtration rate, as defined by the National Kidney Foundation.

Sources: “End Stage Renal Disease,” Intellihealth.Com, November 5, 2007; Mauro Verrelli, MD, FRCPC, FACP, “Chronic Renal Failure,” eMedicine, June 7, 2006, retrieved November 8, 2007.

Symptoms

• Abdominal pain;
• Back pain;
• Decreased urination, no urine output, or conversely, high urine output;
• Detectable abdominal mass;
• Diarrhea, or bloody diarrhea;
• Difficulty breathing;
• exposure to heavy metals or toxic solvents
• Fatigue;
• Fever;
• Headache;
• Hemorrhage;
• Hiccups;
• History of recent infection;
• History of trauma ;
• Inflammation of the covering of the heart;
• inflammation of the eye;
• Itching;
• Muscle cramps;
• Nausea;
• Nosebleeds;
• Pale skin;
• Poor appetite;
• Rash;
• Seizures;
• Severe vomiting;
• Swelling of the tissues;
• Weakness; and
• Weight loss.

General Information

End-stage Renal Disease (ESRD) is a condition in which the kidneys cease to function as normal. Typically, ESRD is diagnosed when the kidneys are functioning at less than 15% of their normal capacity and will fail, causing the death of the patient, sometimes within weeks, if a kidney transplant donor is not found. At this point, a mechanical process called dialysis is used to do the kidney’s work, or a kidney transplant is required to prevent major complications, including death.

ESRD can be caused by high blood pressure, vascular disease, rheumatic or autoimmune diseases, genetic disorders, or exposure to toxic drugs, such as contrast dyes and certain antibiotics.

Sources: “End Stage Renal Disease,” Intellihealth.Com, November 5, 2007; Mauro Verrelli, MD, FRCPC, FACP, “Chronic Renal Failure,” eMedicine, June 7, 2006, retrieved November 8, 2007; Richard Dingwall, et.al, Royal Infirmary of Edinburgh, “End stage renal failure and its treatment,” renux.dmed.ed.ac.uk/EdREN, July 25, 2006, retrieved November 8, 2007.

Trasylol Pulled from US Market: A Timeline of Events

Trasylol, known generically as Aprotinin, is manufactured by Bayer AG and is administered by injection during coronary artery bypass graft (CABG) surgery (commonly known as cardiac bypass surgery) to induce clotting in the blood, preventing hemorrhaging.

Trasylol doubles risk of serious damage to major organs

A study reported January 25, 2006, in the New England Journal of Medicine shows that Trasylol is linked to serious, life-threatening side effects. The study of 4,374 patients demonstrated that Trasylol at least doubles the risk of kidney failure and stroke, or encephalopathy, and raises the risk of heart failure or heart attack by 55 percent.

The study estimates that as many as 10,000 patients may now be on dialysis due to kidney failure after cardiac bypass surgery where they were administered Trasylol. In the study, data was collected from more than 4,300 patients undergoing revascularization surgery at more than 69 centers around the world between 1996 and 2000. The patients received either Trasylol, aminocaprioic acid, tranexamic acid, or no treatment.

The Trasylol group had double the risk of chronic kidney failure requiring dialysis usually observed in patients undergoing complex coronary-artery surgery or primary surgery.

The Trasylol group also had:

• a 48 percent increased risk of heart attack;
• a 109 percent increased risk of heart failure; and
• a 181 percent increased risk of stroke or encephalopathy.

The two generic drugs used in the study, aminocaprioic acid and tranexamic acid, are not only significantly less expensive than Trasylol, but much less risky. Neither group of patients receiving the generic drugs experienced these increased risks.

Halting Trasylol use might prevent 10,000 kidney failures a year

The study’s lead author, Dr. Dennis Mangano of the Ischemia Research and Education Foundation in San Bruno, CA, was quoted as saying, “In good conscience, I could not administer (Trasylol) to this group of patients, especially given the availability of safer alternatives.” The article said halting aprotinin use globally would prevent 10,000 to 11,000 cases of kidney failure a year and save more than $1 billion a year in dialysis costs, as well as nearly $250 million spent on the drug itself.

Source: Thomas H. Maugh II, “Multiple Risks of Surgery Drug Seen,” Los Angeles Times, January 26, 2006

Trasylol raises death risk nearly 50 percent

A study published in the February 7, 2007, issue of the Journal of the American Medical Association adds more evidence to the theory that the risks of using the Bayer drug Trasylol (aprotinin), an anti-bleeding medication used during coronary artery bypass graft (CABG) surgery, far outweigh the drug’s benefits. The report, authored by Dr. Dennis T. Mangano, director of the California-based nonprofit Ischemia Research and Education Foundation, found that Trasylol appears to raise the risk of dying within five years after CABG surgery by 48 percent.

According to the study, the five-year death rate for patients given Trasylol was 20.8 percent, compared to 15.8 percent for those given adminocaproic acid and 14.7 percent for those given tranexamic acid. The scientists then performed a multivariate logistic regression analysis to see which of the medications was most closely associated with mortality. They found the presence of Trasylol during CABG surgery to be the strongest predictor of increased mortality over the five year period, a 48 percent increased risk of death, compared with no increased risk of death with either adminocaproic acid or tranexamic acid.

Sources: Carla K. Johnson, “Extra deaths add to concern about heart-surgery drug,” Associated Press, February 7, 2007; “Anti-Bleeding Drug Increases Death Risk Following Heart Surgery,” Medical News Today, February 7, 2007; Ed Edelson, “Heart Surgery Drug May Boost Death Risk,” HealthDay News, February 6, 2007; Dennis T. Magano, Ph.D., M.D., et.al, “Mortality Associated with Aprotinin During 5 Years Following Coronary Artery Bypass Graft Surgery (abstract),” Journal of the American Medical Association 297:5, February 7, 2007.

Renal failure patients face serious risk of digitalis toxicity

Patients suffering from renal failure who take recalled double-strength Digitek are significantly at risk for digitalis toxicity. This is a condition in which the amount of digitalis in the blood becomes too high, causing toxic effects. Some symptoms of digitalis toxicity include:

• nausea,
• vomiting,
• dizziness,
• low blood pressure,
• cardiac instability, and
• bradycardia.

Do you need a Digitek Lawyer? – Free Call, No Obligation

If you or someone you love has taken Digitek, you should be aware that a manufacturing mistake may have already caused numerous injuries and deaths in patients.

Contact our personal injury law firm today. A consultation with a product liability lawyer may be in your best interest. If Actavis knew of safety violations in its manufacturing plant, you may be entitled to compensation for the injuries you may have suffered as a result.

Our product liability lawyers are investigating the circumstances surrounding this drug. Your information will be reviewed by a lawyer who may be able to help you gain compensation from a Digitek lawsuit.

Sources: “Digitek Recall Blamed on Shoddy Manufacturing,” News Inferno, June 4, 2008 (http://www.newsinferno.com/archives/3199); “Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP) as precaution,” US Food and Drug Administration Press Release, April 25, 2008.

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