Very professional service . Joanne is one of the best there!
Camelia Hendricks
5 years ago
FDA Issues Boxed Warning for Osteoporosis Drug Denosumab (Prolia) In a recent development, the Food and Drug Administration (FDA) has taken a significant step by adding a boxed warning to the label of the osteoporosis drug denosumab, commonly known as Prolia. This warning specifically addresses the potential risk of severe hypocalcemia in patients with […]
Denosumab Hypocalcemia Lawsuits
In a recent development, the Food and Drug Administration (FDA) has taken a significant step by adding a boxed warning to the label of the osteoporosis drug denosumab, commonly known as Prolia. This warning specifically addresses the potential risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), as announced by the agency on a recent Friday.
The decision to implement this boxed warning follows a comprehensive review of available evidence, including fresh data published in the Journal of the American Medical Association (JAMA). Based on their analysis, the FDA has concluded that denosumab carries an increased risk of severe hypocalcemia, particularly when compared to bisphosphonates, in patients with advanced CKD, particularly those undergoing dialysis. It is important to note that patients on dialysis or suffering from mineral and bone disorder (MBD) are at the highest risk of experiencing significantly low blood calcium levels.
The newly acquired data, primarily involving women undergoing dialysis, revealed alarming statistics. Approximately 41% of patients developed severe hypocalcemia within the initial 12 weeks of denosumab treatment, in stark contrast to only 2.0% of those who were prescribed oral bisphosphonates.
The boxed warning, described by the FDA as the “most prominent” warning, serves as a cautionary notice about the potential for severe harm arising from severe hypocalcemia. This harm could manifest as hospitalization, life-threatening events, and even fatalities among patients with advanced CKD who are using denosumab. Symptoms of severe hypocalcemia may vary from being asymptomatic to presenting with confusion, seizures, irregular heart rhythms, fainting, facial twitches, uncontrolled muscle spasms, or sensations of weakness, tingling, or numbness in specific body areas.
As part of their latest communication on drug safety, the FDA has advised healthcare professionals to exercise utmost caution in selecting appropriate candidates for denosumab treatment. Furthermore, they recommend intensified monitoring of blood calcium levels, especially during the initial 2 to 10 weeks following each injection. In some cases, patients may also require calcium and vitamin D supplements to manage their condition effectively.
Before prescribing denosumab, healthcare providers are strongly encouraged to assess their patients’ kidney function and carefully consider the risk of severe hypocalcemia in the context of other available osteoporosis treatment options for patients with advanced CKD, particularly those undergoing dialysis.
The FDA underscores the importance of patients not discontinuing their denosumab medication without first consulting their healthcare provider. Abruptly ceasing treatment may have adverse consequences, and patients are advised to seek professional guidance in this matter.
This label update by the FDA follows an initial safety alert issued in November 2022, which highlighted the potential risk of hypocalcemia associated with denosumab in women dependent on dialysis. The alert was prompted by interim findings from Amgen, the manufacturer of denosumab, as part of an ongoing safety study that indicated an elevated risk of hypocalcemia in patients with advanced kidney disease.
Originally approved in 2010 for postmenopausal women at high risk of bone fracture due to osteoporosis, denosumab has expanded its indications over time. It is now used to treat osteoporosis in men, glucocorticoid-induced osteoporosis, bone loss in patients receiving androgen-deprivation therapy for prostate cancer, and in women undergoing aromatase inhibitor therapy for breast cancer. Additionally, it is approved under the trade name Xgeva to reduce the risk of bone-related events in specific cancer patients.
Administered via injection every six months, denosumab functions by inhibiting the protein receptor activator of nuclear factor kappa beta (RANK), thereby preventing the breakdown of bone by osteoclasts in the body.
The FDA encourages both patients and healthcare professionals to promptly report any side effects related to denosumab to their MedWatch program, ensuring that concerns are addressed and safety is prioritized.
If you or a loved one have experienced adverse effects or harm from denosumab (Prolia), it is crucial to seek legal guidance to understand your rights and options. Victims of such pharmaceutical issues may have grounds for legal action to seek compensation for their injuries. Product liability lawsuits can hold manufacturers accountable for producing and distributing defective drugs that cause harm to consumers.
The process of pursuing a product liability lawsuit is intricate and often necessitates the expertise of an attorney at each stage to ensure a favorable outcome. Here is an overview of the steps involved and the reasons why legal representation is crucial:
Legal representation is paramount at each step of this complex process, as attorneys possess the necessary expertise to navigate legal intricacies, advocate for the victim’s rights, and ensure they receive fair compensation for their suffering.
The FDA’s decision to issue a boxed warning for denosumab (Prolia) underscores the gravity of the situation and the potential harm this drug can cause. Victims of such pharmaceutical issues have legal avenues to seek compensation for their injuries, and seeking the counsel of an experienced attorney is vital to navigating the complexities of a product liability lawsuit. Take proactive steps to address your concerns, and reach out to trusted law firms like Parker Waichman LLP to ensure your rights are safeguarded.
Parker Waichman LLP is a nationally acclaimed personal injury law firm committed to safeguarding the rights of those who have suffered due to the negligence of others. Our nationwide law firm has earned a distinguished reputation, founded on our unwavering dedication to securing justice and delivering award-winning advocacy on behalf of our clients throughout the United States. Our law practice is exclusively focused on personal injury law, and we are unyielding in our pursuit of just monetary compensation for the suffering our clients have endured.
If you or someone you know has been affected by the risks associated with denosumab (Prolia), we encourage you to take action by contacting a reputable national product injury law firm such as Parker Waichman LLP. They offer free consultations to victims who call 1-800-YOUR-LAWYER (1-800-968-7529). Don’t hesitate to seek professional guidance and protect your rights in the pursuit of justice and compensation for your injuries.
Regardless of your location or where your injury occurred, our nationwide personal injury law firm is ready to assist you.