Manufacturer: Novartis

Indications: Zoledronic acid injection is indicated for patients with hypercalcemia of malignancy, for patients with multiple myeloma, and for patients with documented bone metastases from solid tumors, in conjunction with standard antineoplas-tic therapy. Prostate cancer should improve after treatment with at least one hormonal therapy.

Reason for Labeling Change: Cases of osteonecrosis (primarily involving the jaws) have been reported in patients treated with bisphosphonates, including zoledronic acid. Most reported cases have been in patients who were undergoing dental procedures, such as tooth extraction, and who were also receiving cancer treatment, including chemotherapy and corticosteroids. Osteonecrosis of the jaw is associated with multiple well-documented risk factors, including a cancer diagnosis; concomitant therapies (e.g., chemotherapy, radiotherapy, and corticosteroids); and additional conditions (e.g., anemia, blood clot disorders, infection, and pre-existing dental disease).

A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with risk factors for osteonecrosis. While receiving treatment for cancer, these patients should avoid invasive dental procedures if possible. If jaw osteonecrosis occurs during bisphosphonate therapy, dental surgery may exacerbate the condition. For patients who require dental procedures, it is not clear whether discontinuation of bisphosphonate treatment might reduce the risk of jaw osteonecrosis. Action Taken: Revisions under the Precautions and Adverse Reactions sections of labeling describe spontaneous reports of osteonecrosis of the jaw mainly in cancer patients who have received bisphosphonates as a component of their therapy. Appropriate preventive dentistry should be considered before patients are given bisphosphonates if they have concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, or poor oral hygiene).

Conclusion: These revisions are essential for the potential safety issues that can arise with the use of zoledronic acid in patients with multiple myeloma. Preventive dental treatment should be considered before bisphosphonates are given to patients with concomitant risk factors for osteonecrosis. Patients who have been taking zoledronic acid for months may require a different approach. canadian pharmacy cialis

In general, patients should inform their dentist if they are taking bisphosphonates. These patients should be monitored carefully, and some dentists have recommended it. Some patients might even consider discontinuing bisphosphonate therapy before they undergo a dental procedure.

Infliximab (Remicade®)

Manufacturer: Centocor

Indication: This agent is used to treat patients with rheumatoid arthritis and Crohn’s disease.

Reason for FDA Intervention: In controlled studies of all tumor necrosis factor-a (TNF-a)-blocking agents, including in-fliximab, more cases of lymphoma have been observed in patients taking the agents than in control patients. Malignancies have also been observed in open-label, uncontrolled clinical studies at a rate several-fold higher than that expected in the general population. Patients with Crohn’s disease or rheumatoid arthritis, particularly those with highly active disease or chronic exposure to immunosuppressant therapies, may be at a higher risk than others for the development of lymphoma. Label Change: The FDA recommends that a warning concerning malignancy be added to the labeling for all therapeutic agents that block TNF.
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Category: Drugs / Tags: Drug Safety, Efavirenz, Levothyroxine, Rituximab, Zoledronic Acid

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