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Osteonecrosis of the Jaw from Fosamax
of the Jaw
Jaw osteonecrosis - bisphosphonates - Fosamax side effects


Osteonecrosis of the Jaw News

Osteonecrosis Warning
Cancer drugs preclude some dental procedures

By Mark Berthold

05/12/2005 - East Hanover, N.J. — Cancer patients treated with intravenous bisphosphonate drugs may be at increased risk for developing "osteonecrosis of the jaw" — and they should not undergo invasive dental procedures, advises a pharmaceutical manufacturer.

Novartis Pharmaceuticals Corp. is sending a letter to dentists across the country, informing them that ONJ has been observed in cancer patients who are receiving Aredia or Zometa — bisphosphonates used to treat complications of advanced cancer known as "hypercalcemia of malignancy."

Novartis recommends that cancer patients receive a dental examination prior to initiating therapy with Aredia or Zometa, and avoid invasive dental procedures while receiving these drugs because dental surgery may exacerbate the ONJ condition. It has added precautionary information on ONJ to the package insert for both products.

Novartis also encourages dentists to report any serious adverse events related to Aredia or Zometa to its toll-free number, 1-800-882-6577, or to the Food and Drug Administration's MedWatch Adverse Event Reporting program, by phone at 1-800-FDA-1088 or online at www.fda.gov/MedWatch.

For more information, contact Novartis Oncology Medical Services at 1-888-669-6682.

Bisphosphonate use growing

Bisphosphonate drugs are fairly common in the United States: greater than 23 million Americans took the oral form in 2003 to treat osteoporosis and other conditions, according to Dr. John W. Hellstein, clinical professor of oral and maxillofacial pathology at the University of Iowa.

"Less than 10 percent of reported cases of 'osteonecrosis of the jaw' are related to oral bisphosphonates," he says, "so the risks associated are real — but so far rare."

On the other hand, Dr. Hellstein believes, infusible bisphosphonates have a much higher risk of ONJ — about 90 percent of reported cases. Infusible bisphosphonates are used to treat cancers such as metastatic breast cancer, prostate cancer and multiple myeloma.

Signs of ONJ include exposed bone; pain, swelling or infection of gums; loosening of teeth; poor healing of gums; numbness or feeling of heaviness in the jaw; and draining with sequestration.

Problems have occurred after a tooth extraction in dental patients who had received the drug up to a year prior. The extraction site becomes necrotic and affects the surrounding bone, so that part of the jaw eventually may have to be removed. Spontaneous exposure of tori or the internal oblique ridge have also been reported.

However, "currently there are no indications to stop taking oral bisphosphonate medications for osteoporosis, such as ibandronate, alendronate or risidronate," says Dr. Hellstein. "And we don't want cancer patients to stop taking their infusible bisphosphonate, such as pamidronate or zoledronate, for hypercalcemia of malignancy."

What Dr. Hellstein wants is for the dentist to be aware of the possible complications associated with periodontal disease, tooth extraction, exposed tori or dentoalveolar/perioral trauma, especially in patients having a history of being administered infusible bisphosphonates.

Thus, much more attention and reporting of complications associated with the oral bisphosphonates, he believes, will help delineate the risks associated with osteoporosis medications.

"Preventive dentistry and good oral health care are still the best tools to reduce risks due to these medications and reduce complications in these patients already medically at risk," he says.

Dr. Hellstein adds that conservative treatment modalities are being evaluated for patients who do experience ONJ and how to manage patients requiring tooth extractions or bone exposure.

Study shows drug prevents arthritic bone loss

Aug 16, 2006 - BOSTON (Reuters) - The Merck and Co. drug Fosamax does a better job at preventing bone deterioration than Vitamin D for people using steroids to treat arthritis, a study showed on Wednesday.

Researchers found that Fosamax increased the density of bones in the spine by just over two percent in the 100 volunteers who received it along with steroids for 18 months, the study said.

The 101 volunteers treated with alfacalcidol, a form of Vitamin D, saw their density decrease by almost 2 percent over the 18-month period, according to the study led by Ron de Nijs of the University Medical Center Utrecht in the Netherlands.

A similar trend was seen in other bones, the researchers said in this week's New England Journal of Medicine.

Although steroids have been known to help relieve joint pain for sufferers of arthritis, doctors have known for years that some steroids such as prednisone can weaken bones.

FDA OKs Once-Yearly Osteoporosis Drug

Reclast Given By IV; First Drug in Class to Be Given Once a Year

By Sean Swint
WebMD Medical News
Reviewed by Michael W. Smith, MD

Aug. 17, 2007 – The FDA today approved Reclast, the first once-yearly drug for postmenopausal osteoporosis, according to the manufacturer Novartis.

The drug was previously approved by the FDA in April for Paget's disease, which can result in misshapen bones in one or more areas of the body. This is the first indication for the drug for osteoporosis, a disorder that causes bones to break easily.

Reclast is given by infusion. Its active ingredient, zoledronic acid, is also marketed by Novartis under the brand name Zometa for use in certain cancer patients.

The drug belongs to a class of medications called bisphosphonates, which also includes the osteoporosis drugs Actonel and Fosamax, which are usually taken once a week, and Boniva, which is taken monthly. All are in pill form.

Reclast is given as a once-yearly 15-minute intravenous (IV) infusion.

The Research on Reclast

A recent study in The New England Journal of Medicine involving more than 7,700 women showed that Reclast reduced spine fractures by 70% and hip fractures by 41%, compared with placebo. The reduction in spine fractures was sustained over three years.

According to the manufacturer, Reclast increases bone strength and reduces fractures in areas of the body typically affected by osteoporosis, including the hip, spine and other areas such as the wrist, arm, leg, or rib.

"Osteoporosis is a serious disease affecting millions of people in this country," says Leo Schargorodski, executive director of the National Osteoporosis Foundation (NOF), in a Novartis news release. "NOF welcomes new FDA approved treatment options, such as Reclast, that give patients a choice when it comes to taking their osteoporosis therapy."

Reclast is not intended for patients with hypocalcemia (low blood calcium) and those who are allergic to zoledronic acid. Patients already being treated with Zometa should not be treated with Reclast.

Reclast should also not be used during pregnancy because of potential harm to the fetus. And Reclast is not recommended for use in patients with severe kidney impairment.

The most common side effects associated with Reclast are fever; pain in the muscles, bones, or joints; flu-like symptoms; and headache. These symptoms usually occur within the first three days following Reclast administration and usually resolve within three to four days of onset, but resolution could take up to seven to 14 days.

Some patients have reported severe bone, joint, and/or muscle pain after using bisphosphonates. Osteonecrosis of the jaw (damage to the bone) has been reported rarely in postmenopausal osteoporosis patients treated with bisphosphonates. A routine oral examination should be performed by the doctor prior to initiation of treatment, according to the manufacturer.



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