Reclast Lawsuit Information
Reclast is the brand name for zoledronic acid, a medication that is used to treat pre-osteoporosis conditions in both men and women. Manufactured by Novartis, it was approved by the FDA in June of 2007 for use as a one-time, yearly treatment to be given by injection on an annual basis. More recently on June 3 of 2009 approval was given for a form of Reclast for which treatment requires an injection just once every two years.
On the Market for Two Years
In the two years since its introduction this drug has been given to at least 500,000 patients worldwide. It is on the market in eighty countries, marketed in Europe under the name Aclasta. The FDA has given its approval for use on a biennial basis despite the fact that since its approval in 2007, Reclast has been associated with acute kidney problems in a number of patients.
Dangerous for Patients who may have Renal Problems
Recently Novartis changed the warning information packaged with the drug to include the possibility of acute renal failure. Added to the information for medical professionals were the suggestions that the drug be infused over a period of at least five minutes; that patients with a history of renal impairment not be given the drug, and that patient monitoring for creatinine be included in the treatment process. Serum creatinine plays an active role in acute renal failure; patients with a history of kidney problems or with certain creatinine levels should not be treated with Reclast, according to its manufacturer.
Seven Fatalities in Two Years
Although the number of post-marketing reports linking Reclast to acute renal failure has been relatively small, seven of those occurrences have been fatal. If you or a relative is being treated for an osteoporotic condition with this medication and has suffered severed side effects, you should consider consulting a legal expert in dangerous medications as well as seeking additional medical help.