Got Bones? » August 2006

August 21, 2006

The Fosamax Debate Goes On

Evelyn Pringle has written a great piece on the side effects of Fosamax and the debate over what to do about it.

Merck's second-best selling drug, Fosamax, has been linked to jaw bone death, a condition that can involve severe pain, infection, loose teeth, exposed bone, loss of function and disfigurement, according to the American Association of Oral and Maxillofacial Surgeons. And yet sales of the drug remain steady with no decrease whatsoever.

Merck Keeps Right On Pushing Fosamax

Posted by Staff at 3:39 AM | Comments (2)

August 15, 2006

VEPTR Instead of Fusion for Congenital Scoliosis

Congenital scoliosis, a severe and often life-threatening form of scoliosis, is often treated with spinal fusion to prevent it from getting worse, but that causes its own set of problems. Fusion prevents the spine from growing further. When done on very young children, this lack of spinal growth doesn't leave enough room for the heart and lungs as they continue to grow normally.

A new device called a Vertical Expandable Prosthetic Titanium Rib, or VEPTR, straightens out the spine while still allowing it to grow. Dr. John Blanco is a pediatric orthopedic surgeon with Children's Healthcare of Atlanta and has been working with the new device and speaks about a recent surgery he performed on a young girl:

“It consists of 2 rings of metal that encircle either one rib or 2 ribs above where the deformity is,” says Dr. Blanco. "And at some point she will need an operation to stop the growth of her spine, but she’s way too young for it right now."

New Spinal Device Changes Children's Lives
Children's Healthcare of Atlanta

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August 9, 2006

Fosamax and Bisphosphonate Timeline

Many researchers and doctors are calling the jaw problems associated with Fosamax and other bisphosphonates "bis-phossy jaw." This is derived from the 19th century term "phossy jaw." It turns out there's a long relationship between phosphorus and jaw necrosis. Note the "phos" in bisphosphonate. It's there because these drugs are phosphorus-based. Here's a short timeline of phosphorus, bisphosphonates, and osteonecrosis of the jaw. This timeline is a work in progress and additional information will be added.

phossy jaw 19th Century: Match factory workers come down with something called "phossy jaw." It is caused by exposure to white phosphorus. Their jaws abscess, causing pain and disfigurement. Foul-smelling pus drains from their jaws and their jaws glow in the dark (due to the phosphorus). The only treatment is removal of the jaw bone. If these steps are not taken, organ failure occurs and then death. The photograph to the left is of a man with phossy jaw.

Sept. 29, 1995: The FDA approves bisphosphonate drug Fosamax (alendronate sodium) for the treatment of post-menopausal osteoporosis and Paget's disease.

2001: Oral surgeon Salvatore Ruggiero notices that an unusual number of his patients have osteonecrosis of the jaw. He does some digging into their medical records and discovers they are all taking a bisphosphonate called Aredia. He phones Aredia's manufacturer, Novartis AG, and asks them if there are other cases of osteonecrosis related to the drug. He also submits reports to MedWatch.

2002: Not having heard back from the FDA after submitting his reports to MedWatch, Ruggiero calls MedWatch to ask whether they have received his information. "How many of these do I have to put on before something gets done?" he asks.

2003: The FDA takes notice as several reports of osteonecrosis from use of bisphosphonate drugs are submitted to their "postmarketing database."

Summer 2003: Oral surgeon Robert Marx, a department chief at the University of Miami's Miller School of Medicine, has 36 cases of osteonecrosis of the jaw that he suspects are linked to Aredia and Zometa. He calls Novartis to let them know he is planning to write a medical alert in the Journal of Oral and Maxillofacial Surgery warning of the problem.

Sept. 2003: Marx's article is published in the Journal of Oral and Maxillofacial Surgery.

Dec. 2003: By this time, Dr. Ruggiero has 54 patients with osteonecrosis of the jaw.

Aug. 25, 2004: The FDA reviews new cases of osteonecrosis associated with pamidronate and zoledronic acid that have been submitted to them. They also review cases of osteonecrosis associated with oral bisphosphonates. Their recommendation is that the labels be changed to warn patients about the risk of osteonecrosis of the jaw.

Sept. 2004: By this time, Novartis has received 500 case reports of jaw problems in patients taking Aredia and Zometa. The company decides to add a "precaution" to the labels of its bisphosponate drugs Aredia and Zometa and sends letters to doctors alerting them to the problem.

July 2005: Almost a year after the FDA recommended they do so, Merck adds a warning to Fosamax. The warning is buried several pages deep in the package insert.

2005: During 2005, 22.4 million prescriptions for Fosamax are given out.

April 2006: Linda Secrest files a class action lawsuit in Florida against Merck for not warning patients about the risk of osteonecrosis of the jaw in patients taking Fosamax. Hundreds of similar lawsuits are expected to be filed.

July 2006: Earnings reports for Merck are released. The company reports that Fosamax earned $821 million for the second quarter of 2006.

Posted by Tracy at 8:15 AM | Comments (4)

August 8, 2006

Watching for Late-onset Scoliosis in Teens

Scoliosis, or curvature of the spine, can strike as early as age five but usually shows itself in adolescence. It is more common in girls. Doctors, families, and schools need to watch for it as the child grows. Treatment depends on the severity of the curve and can include surgery, a brace, "watchful waiting", or a new procedure called stapling.

Late-onset idiopathic scoliosis -- or LIS -- is the most common form of the disease and is generally diagnosed after the age of 10. The condition, which has no known cause other than genetics, affects 3 percent of children between the ages of 8 and 16, and about 60,000 teens in the United States.
Scoliosis Not Just a Problem for the Elderly

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August 7, 2006

Second-Hand Smoke May Lead to Osteoporosis

A Chinese study by scientists from the Harvard School of Public Health has found a link between inhaling second-hand smoke and osteoporosis. They studied 14,000 men and women who lived with at least one smoker every day.

They found that a pre-menopausal woman who lived with one smoker doubled her osteoporosis risk. If she lived with two more smokers, the risk tripled, BBC News reports. The women also had a 2.6 times greater risk for a non-spine fracture, compared to non-smokers, the researchers found.

2nd-Hand smoke: Bad for the bones

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August 5, 2006

Bone Loss May Begin Long Before Menopause

MaryFran Sowers, a University of Michigan researcher and professor, says women may begin losing bone mass as early as ten years before the onset of menopause.

Her research is part of the Study of Women's Health Across the Nation (SWAN), a project following 3,300 women ages 40 to 55, who agree to undergo yearly exams, take tests and answer survey questions.

Study says women's bone loss may start earlier

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August 1, 2006

High Dose Steroids Cause Osteoporosis

Researchers are trying to find the connection between osteoporosis and high dose steroid use. With the help of genetically modified mice they are finding some interesting answers.

"High-dose cortisone is the second most common cause of osteoporosis, and we currently have no real treatment for this serious side effect," says senior author Steven L. Teitelbaum, M.D., Messing Professor of Pathology and Immunology. "Given how frequently these drugs are used to treat many different conditions, that's a major clinical problem.

Why Do Steroids Cause Osteoporosis?

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