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Archive for the ‘Osteonecrosis of the jaw (ONJ)’ Category

Wednesday, March 25th, 2009

On March 23, 2009, officials stated that thousands of veterans in South Florida may have been exposed to hepatitis and HIV as a result of unsanitary equipment after receiving colonoscopies at the Miami Veterans Affairs Healthcare System.

Two Florida lawmakers are asking for an inspector general’s inquiry.

“The VA is a model of the type of health care we provide our veterans, and when mistakes like this occur, it undermines the efficacy of the entire system,” said Rep. Kendrick B. Meek, D-Florida, in a news release. Meek, along with Sen. Bill Nelson, D-Florida, is requesting an official inquiry by the inspector general of the VA.

In a letter to retired Gen. Eric Shinseki, the secretary of Veterans Affairs, Nelson said he is also concerned about possible contaminated equipment at facilities in Murfreesboro, Tennessee, and Augusta, Georgia.

“I am requesting that the VA Office of Inspector General begin an investigation into the potential problems of contamination; whether any patient has contracted an infection from unsterilized equipment; and, most importantly, how we can prevent such problems from happening again,” Nelson wrote.

“Finally, I urge the VA to commit to providing ongoing medical care in cases where it is responsible for exposing someone to a disease.”

On March 23, 2009, the VA sent letters to 3,260 people who may have had colonoscopies between May 2004 and March 12, 2009. Hospital officials said a review of safety procedures found that tubing used in endoscope procedures was rinsed but not disinfected.

In the first 24 hours after the letters were released, the Miami VA got more than 2,600 calls and checked out more than 350 patients. Almost 600 more are scheduled for examinations over the next two weeks, officials at the facility said.

“What happened should not have happened. We are taking steps to change it right now,” said John Vara, the Miami VA’s chief of staff.

The problem at the Miami VA facility comes on the heels of similar problems with endoscopies at the VA clinic in Murfreesboro. In December 2008, an investigation discovered that clinic workers were not following manufacturer’s directions and switched out parts they weren’t supposed to switch out, according to investigators. Approximately 6,000 people who underwent colonoscopies at the clinic were notified and offered free testing for infections.

The Charlie Norwood VA Medica Center in Augusta, Georgia, also said it had “recently notified 1,200 veterans they may have been exposed to infection when undergoing ear, nose and throat (ENT) procedures between January and November of 2008.”

In Miami, the VA has opened “special care clinics” to test veterans who received the notice and to provide information.

“Screening is strictly precautionary and does not indicate that any patients have contracted a virus,” Mary D. Berrocal, director of the Miami VA, said in a statement on the VA’s Web site.

The special care clinics opened Tuesday morning, and officials say response from patients has been good. “They are being proactive, and we are glad. We want them to get tested,” said Susan Warren, a spokeswoman for the Miami VA facility.

Osteoporosis Drugs Cause Jaw Problems

Friday, January 2nd, 2009

A new study released on January 1, 2008 suggests that patients prescribed oral osteoporosis drugs may be at a much higher risk of developing Osteonecrosis of the jaw (ONJ). Past reports indicated that the risk of developing Osteonecrosis of the jaw (ONJ) from bisphosphonates in pill form were “negligible,” although there was a noted risk in people taking the higher-dose intravenous form of the drug.

But Dr. Parish Sedghizadeh, an assistant professor of clinical dentistry at the University of Southern California School of Dentistry in Los Angeles, said his clinic is seeing one to four new cases a week, compared to one a year in the past. This led him to investigate the phenomenon and publish the findings in the Jan. 1 issue of the Journal of the American Dental Association.

“This is more frequent than everybody would like to think it is,” said Sedghizadeh, lead author of the study.

ONJ is characterized by pain, soft-tissue swelling, infection, loose teeth and exposed bone.

Dr. James Liu, chairman of obstetrics and gynecology at MacDonald Women’s Hospital at Case Medical Center, University Hospitals in Cleveland, said the finding “does not mean that women should stop taking the drug if they’re on it. It does mean that there may be more frequent side effects than was previously known.”

Bisphosphonates are medications used to reduce the risk of bone fracture and to increase bone mass in people with osteoporosis. They’re also used to slow bone “turnover” in people who have cancer that has spread to their bones, and in people who have the blood cancer multiple myeloma.

Use of bisphosphonates has been associated with other problems in the past, including an increased risk of atrial fibrillation (a type of abnormal heart rhythm), unusual fractures of the thigh bone, and inflammatory eye disease.

After searching the USC School of Dentistry’s electronic medical records database, the study authors found that nine of 208 patients taking Fosamax had active ONJ, a prevalence of about 4 percent. All were patients who had undergone some kind of dental procedure, such as having a tooth removed.

Fosamax (generic: alendronate) is the most widely prescribed oral bisphosphonate and has been the 21st most prescribed drug in the United States since 2006, according to background information in the study.

The jaw complication has been seen in patients taking Fosamax for as little as one year. It seems to occur most frequently after routine tooth extraction, the study authors said.

Although no one is sure why bisphosphonates seem to have this effect only on jaw bones, Sedghizadeh speculated that the drugs may make it easier for bacteria to adhere to bone that is exposed after a tooth extraction.

Previously, experts had thought that ONJ in people taking intravenous bisphosphonates was related to their underlying condition (for example, cancer) than to the actual drug, Liu explained.

The USC School of Dentistry now screens every patient for bisphosphonate use.

“As a school now, we don’t have complications any more, we only have referrals,” Sedghizadeh said. “We put patients on anti-microbial, anti-fungal rinse one week pre-operatively or post-operatively. If they have been on bisphosphonates six months or a year or longer, then we have a prevention protocol which has been very, very effective.”

According to a statement released by Merck & Co., which makes Fosamax, the new study “has material methodological flaws and scientific limitations, making it unreliable as a source for valid scientific conclusions regarding the prevalence of ONJ in patients taking alendronate.”

No reports of ONJ have been noted in controlled trials involving more than 17,000 patients, the statement said.

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