FDA Alerts: Fosamax, Aredia, Zometa

10/26/2008

The Food and Drug Administration monitors the potential side effects of popular drugs in order to ensure public health and safety. Drugs such as Fosamax, Aredia, and Zometa have been the objects of such recent speculation about their risks vs. benefits, due to a rising number of claims that these drugs can be responsible for several serious side effects, including osteonecrosis of the jaw.

The FDA Alerts: Fosamax, Aredia, and Zometa began with a letter dated September 24, 2004 that was sent to oncologists, dentists, and other healthcare professionals to inform them about the propensity of Novartis' Zometa to cause severe dental side effects. This letter was followed by another warning to dentists and doctors in May 2005 about the risks of Aredia, Novartis' other bisphosphonate drug.

In August, 2004, Fosamax was a target of an FDA Office of Drug Safety Postmarketing Safety Review panel recommendation that packaging for bisphosphonate drugs like Fosamax such as Zometa, Aredia, and Actone immediately carry stern warnings about the potential for serious complications such as osteonecrosis of the jaw. Recent class action lawsuits contend that it took Merck almost a year to alter the packaging for Fosamax to warn people of the increased danger.

Doctors wrote 22.4 million prescriptions for Fosamax in 2005, and each one of these people could potentially suffer the misery of osteonecrosis of the jaw. If you or someone you know developed this devastating condition or another Fosamax side effect, you need to consult with a compassionate and experienced attorney immediately. You may be able to take legal action against those responsible for your agonizing condition, and you could be entitled to a financial compensation package for your physical pain and emotional suffering.

On Friday, March 4, a meeting of the FDA's Oncologic Drugs Advisory Committee (ODAC) considered the condition of osteonecrosis of the jaw (ONJ) as associated with infusional bisphosponates in patients being treated for metastatic bone disease, principally for multiple myeloma and breast cancer, with some data also for prostate cancer.

There were presentations from the Office of Drug Safety of the FDA, from researchers and patient advocates, and from the manufacturer of the bisphosphonate Zometa (zoledronic acid), Novartis. According to Dr. Richard Pazdur, Director of Oncology Drug Products, CDER, FDA, he stated purpose of the meeting was to raise public awareness of this problem.

Warnings regarding ONJ have already been added to labeling information for both of the drugs in question.

Aredia (pamidronate) was approved in 1991, and is indicated for bone metastases from breast cancer and multiple myeloma, and Paget's Disease of the Bone.

Studies measured incidence of "skeletal related events," a composite endpoint that includes pathologic fractures, radiation therapy to bone, surgery to bone and spinal cord compression.

Zometa (zoledronic acid) was approved in 2001, and is indicated for multiple myeloma, bone metastases from solid tumors (not limited to breast cancer), and hypercalcemia of malignancy, a late-stage complication of bone mets.

The lesion type not limited to osteolytic lesions in Zometa, as it had been in Aredia, but also included osteoblastic lesions. The optimal duration of therapy has remained undefined from the various trials, though this is currently being studied.

Typical symptoms for ONJ are pain, soft-tissue swelling and infection, loose teeth and exposed bone. The standard advice currently is to avoid elective jaw procedures while undergoing bisphosphonate therapy, and to have routine dental exams and tooth extractions done prior to bisphosphonate therapy.

A profile of patients with ONJ includes the following factors: diagnosis of malignancy; no head and neck radiotherapy; treatment regimen included IV bisphosphonates; high proportion of recent invasive dental procedures; many patients were also receiving chemotherapy and corticosteroids; many patients had signs of local infection including osteomyelitis; and finally, there was no data to suggest that discontinuing therapy reduces incidence of ONJ.

The true incidence of ONJ is unknown. This is because the MedWatch reporting system is passive, so many cases will go unreported. There are multiple problems with this system. Don’t fail to report your case as it will only hurt you and others too. Contact a knowledgeable defective drug attorney today. "CLICK HERE"