Reclast Linked to Kidney Failure, Risks Underreported in U.S.

The consumer group Public Citizen wants the Food and Drug Administration (FDA) to warn consumers and doctors about a link between the osteoporosis drug Aclasta and serious renal toxicity, which can be fatal. Canada warned the public five months ago, and in a letter to the FDA, Public Citizen’s Health Research Group reports that Canada took action after it was revealed there have been 265 cases of kidney impairment after taking Aclasta, known as Reclast in the U.S. Even though it has a different name from the drug sold in Canada, the drugs are identical.

While Canada has reacted by requiring Novartis, the drug maker, to issue additional and more serious warnings, Dr. Sidney Wolfe wrote to FDA Commissioner Margaret Hamburg that the FDA has failed to require Novartis to alert the public to the possibility of a life-threatening adverse events.

Reclast is given once a year to treat osteoporosis and Public Citizen reports that with one million infusions of the drug, the adverse event rate is about 20 cases per 100,000 patient-years of exposure.

When drugs are released to the public, the FDA frequently does not know whether they will have a long-term benefit until a number of people have taken the drug. Consider it the last stage of a clinical trial when thousands of different types of people are prescribed a drug, and frequently under those conditions, is when we see whether the benefit will outweigh the risk. Certainly, if a patient is prescribed Reclast, they should at least have all of the information about its possible downside, especially since there are other drugs used to treat osteoporosis.

Florida product liability law allows an injured person to hold the manufacturer, seller, and distributor responsible for a dangerous product that may also be defective.

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