The Osteoporosis medication Aclasta, a once-yearly injected medication for postmenopausal osteoporosis that was approved by the FDA in 2007, has been shown to cause renal impairment and failure in certain patients. Notably, patients with a history of kidney problems face greater risks, often necessitating dialysis and sometimes resulting in death. Victims of this medication should seek the help of the prescription drug injury lawyers at our Oklahoma Law Firm.
Aclasta & Renal Failure
The new safety information regarding Aclasta was issued by Health Canada in association with Novartis, a multinational pharmaceutical company based in Switzerland. On October 12, Health Canada issued warnings to health care professionals regarding the dangers of Aclasta. The warnings included:
the association with Aclasta and renal dysfunction and (although rare) acute renal failure
renal impairment following only a single administration of Aclasta
the requirement of dialysis for some patients, specifically those with prior kidney-related health issues, or patients with other risk factors, including advanced age and concomitant diuretic therapy.
In 2007, Aclasta was approved and marketed as a new form of postmenopausal osteoporosis medication that would only require a fifteen-minute intravenous infusion once a year, in contrast with other medications that require administration daily, weekly or monthly. At the time, Aclasta was considered a milestone in treatment for osteoporosis and was not only approved by the FDA, but also by the Committee for Medicinal Products for Human Use and the European Medicines Agency.
Osteoporosis affects 75 million people in the United States, Europe and Japan and one in three women over 50 will experience osteoporotic fractures, as well as one in five men. Many individuals have already sustained an osteoporotic fracture and left it untreated, and, despite advancements in the treatment of osteoporosis, cases of the disease are expected to rise throughout the world over the next several decades.
While Health Canada does not advise that doctors cease treating postmenopausal osteoporosis with Aclasta outright, the organization did present several warnings to health care providers about the increased risks associated with Aclasta versus traditional daily, weekly or monthly treatments for the disease.
If you or a loved one have postmenopausal osteoporosis and have experienced kidney problems or renal failure as a result of intravenous Aclasta treatments, you will need help understanding how to move forward legally and get your life back on track. Contact a skilled defective drugs attorney at Atkins and Markoff today for a consultation.