Reclast Linked to Kidney Failure: How Many are Affected?


April 15, 2011

The FDA approved Reclast in 2007 for treatment of postmenopausal osteoporosis and also for treatment of Paget's disease. Reclast was considered "safe" and serious side effects rare, but the next year the FDA issued a warning that there had been 24 cases of kidney failure and 7 deaths after people underwent Reclast infusions.

The company, Novartis, the maker of Reclast, maintained that warnings were included in the drug packaging and that it was the doctors’ responsibility to warn their patients. The fact that there have been deaths associated with the drug and its use were downplayed.

The drug Reclast is known as a bisphosphonate. It is given as a once yearly intravenous infusion. Most patients are not given a test which can determine whether or not they are likely to suffer Reclast side effects. If the test is not conducted, there is no way of knowing if someone will be susceptible to the side effects. The drug remains in a person’s system for a prolonged period so if a patient is susceptible to the side effects, a subsequent dose can be extremely toxic.

Although the side effects are rare, there is a growing body of evidence linking Reclast to serious and life-threatening problems like kidney failure. In October of 2010, Novartis sent a letter to health care providers in Canada warning them about a potential link between Reclast and renal problems. The drug manufacturer indicated in the letter that there have been at least 265 reports of kidney damage from Reclast as of April 20, 2010.

The United States has not received any warnings to health care providers from Novartis regarding the potential for kidney damage. In March 2011, Public Citizen, a watchdog group, sent a letter to the FDA asking that federal regulators make Novartis warn U.S. patients and health care providers about the risk of renal damage. The letter accuses Novartis of failing to adequately warn physicians and patients in the U.S. of the serious side effects of Reclast. The group has also criticized the FDA for failing to require Novartis to warn U.S. patients and physicians since issuance of the Canadian warning.

According to EhealthMe as of March 8, 2011, 27,384 people reported adverse side effects after taking Reclast. Among those, 59 people reported that their urine output had decreased. There also were 265 cases of renal impairment reported in Canada in 2010. In addition to renal failure, other commonly reported side effects associated with Reclast include muscle, joint and bone pain, fever, flu-like symptoms and in some cases, bone breakage. Product liability law permits a person to recover damages for serious injuries or wrongful death caused by a dangerous or defective drug. If you have experienced kidney damage as a result of taking Reclast, you should contact our attorneys for a free case evaluation.

Montlick and Associates represents clients injured by dangerous medical devices and defective drugs throughout Georgia. If you have suffered serious side effects related to your treatment with Reclast, contact Montlick and Associates to discuss your legal rights. We work hard for our clients to get them the compensation they deserve. Our Georgia Reclast adverse side effect claims lawyers are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. No matter where you are located our attorneys are just a phone call away, and we will even come to you. Call us 24 hours a day/7 days a week for your Free Consultation at 1-800-LAW-NEED (1-800-529-6333). You can also visit us online at www.montlick.com and use our Free Case Evaluation Form or 24-hour Live Online Chat.

Category: Personal Injury

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