Doctors angered by ABC report on bone drugs Dec 19, 2007
The contentious story - presented by Nick Grimm - stated that so-called bisphosphonate drugs can cause the jaw bone to dissolve, a disfiguring condition called osteonecrosis of the jaw, or ONJ.. But the society said the claims were misleading, and warned that if cancer patients stayed off bisphosophonate medications such as Zometa and Aredia for prolonged periods, their disease could more easily spread. (The Australian)
ASK DR. WEIL Beware of drugs for bone boosting Dec 18, 2007
Dentists have observed that some patients on these drugs are at risk of developing an untreatable condition called osteonecrosis of the jaw (ONJ), which can cause chronic pain and disfigurement. Symptoms include toothache, jaw pain, loosening of teeth, recurrent infection of the soft tissue of the jaw and exposed bone. (Houston Chronicle)
Watchdog under fire over 'dead jaw' drug fears Dec 14, 2007
30 Report revealed that increasing numbers of Australians are falling victim to a side effect known as osteonecrosis of the jaw ... The company's Australian subsidiary is now being put on notice to expect a similar class action from those Australians who have developed osteonecrosis of the jaw as a result of using Fosamax. (ABC Online)
Worrying drug side effects: death of the jawbone Dec 13, 2007
It's called osteonecrosis of the jaw ... The bone cancer patient is here because he also has osteonecrosis of the jaw or ONJ, a horrible side-effect of a drug prescribed as part of his cancer treatment. (ABC Online)
Cancer drugs spark 'dead jaw' concerns Dec 11, 2007
An estimated 500 Australians have developed the condition named osteonecrosis of the jaw (ONJ) over the past four years, linked to their prescribed use of bisphosphonate drugs which help to treat osteoporosis. A class action has been launched by ONJ sufferers in the United States, ABC Television reported, where there are questions over whether drug makers have published adequate warnings over side-effect risks. (Sydney Morning Herald -- Australia)
Aastrom Biosciences to Present At RBC Capital Markets Healthcare Conference Dec 8, 2007
Currently, the Company has a vascular regeneration product in clinical development for the treatment of critical limb ischemia (called the RESTORE-CLI trial), a bone regeneration product in Phase III development for the treatment of osteonecrosis of the femoral head (called the ON-CORE trial), and preclinical research programs targeting unmet needs in cardiac and neural health. Aastrom product-candidates to treat osteonecrosis of the femoral head and dilated cardiomyopathy have been designated... (Primezone Releases)
Ugandan Children Are Among the First to Receive Abbott's Lower-Strength Aluvia (lopinavir/ritonavir) Tablet Dec 2, 2007
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis. Signs and symptoms are joint stiffness, aches and pains (especially in the hip, knee and shoulder) and difficulty in movement. (PR Newswire)
Aastrom Biosciences, Inc. Reports First Quarter Fiscal Year 2008 Financial Results Nov 9, 2007
75) one year post-BRC treatment - 100% of the patients who have healed are fully weight-bearing, have regained range of motion and are no longer impaired by their injuries - Severe bone fracture results supported bone regeneration proof of principle and the initiation of Aastrom's U.S. Phase III osteonecrosis of the femoral head clinical trial -- Encouraging interim results from two German research groups utilizing Aastrom's proprietary Tissue Repair Cell (TRC) Technology platform to manufacture... (Primezone Releases)
Zoledronic Acid in Reducing Mortality after Hip Fracture Nov 1, 2007
No cases of osteonecrosis of the jaw were reported, and no adverse effects on the healing of fractures were noted. The rates of renal and cardiovascular adverse events, including atrial fibrillation and stroke, were similar in the two groups. (New England Journal of Medicine)
Aastrom Announces Positive Interim Results From Phase I/II Study Involving Use of Vascular Repair Cells in Patients With Critical Limb Ischemia Oct 4, 2007
Results Presented Today At the Congress of the German Society for Stem Cell Research in Wurzburg, Germany Early Clinical Data Supporting Use of Aastrom Bone Repair Cells (Brcs) in Treatment of Osteonecrosis of the Femoral Head Also Presented ... In another presentation, positive results from the use of Aastrom Bone Repair Cells (BRCs) in the treatment of osteonecrosis of the femoral head were presented ... In a second oral presentation at the same meeting, clinical results were presented by... (Primezone Releases)
New Study Shows Once-Monthly Boniva(R) is as Clinically Effective as Once-Weekly Fosamax(R) at Increasing Bone Mineral Density in Postmenopausal Women With Osteoporosis Sep 20, 2007
Additionally, osteonecrosis of the jaw has been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures. The most commonly reported adverse events with once-monthly Boniva regardless of causality were abdominal pain (Boniva 150 mg 7. (PR Newswire)
Reclast Improves Survival Following Hip Repair, New Study Sep 19, 2007
There were no reported cases of osteonecrosis (loss of blood supply to the bone). No adverse effects on the healing of fractures were observed. (Medical News Today)
Once-a-Year Bone Drug Lowers Fracture Risk Sep 19, 2007
They also found no reports of osteonecrosis of the jaw, a painful jaw condition, which had previously been associated with this class of drugs. More information. (Health-Finder)
Novartis Bone Drug Prevents Fractures, Lengthens Life in Study Sep 19, 2007
In 2005, Novartis warned doctors that some patients on Zometa experienced a condition called osteonecrosis of the jaw, which destroys the jawbone. There were no cases in the study. (Bloomberg)
First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves Survival Sep 18, 2007
No cases of osteonecrosis of the jaw (ONJ) were seen in the study. The most common adverse events with Reclast were transient post-dose symptoms (such as fever, muscular pain, etc). (PR Newswire)
Study: Drug reduces death after hip breaks Sep 18, 2007
Past side effects of zoledronic acid have included abnormal heart rhythms and a rare jaw condition called osteonecrosis, but neither emerged as a risk in the recent trials, Lyles said. newsobserver. (News & Observer)
Once A Year Osteoporosis Drug Reclast Gets FDA Approval Aug 21, 2007
There were no spontaneous reports of osteonecrosis of the jaw (ONJ) in the Pivotal Fracture Trial. ONJ has occurred, albeit rarely, in other trials involving bisphosphonates. (Medical News Today)
First Patient Treated in Aastrom Adult Stem Cell Trial for Critical Limb Ischemia Jun 28, 2007
TRC-based products have been used in over 250 patients, and are currently in clinical trials for bone regeneration (osteonecrosis of the femoral head and long bone fractures) and vascular regeneration (critical limb ischemia applications) ... TRC-based products have received Orphan Drug Designation from the FDA for use in the treatment of osteonecrosis of the femoral head and the treatment of dilated cardiomyopathy, a severe chronic disease of the heart. (Primezone Releases)
Bone Drugs Linked to Jaw Disease in Cancer Patients Jun 28, 2007
NEW YORK (Reuters Health) - Corroborating previous evidence, the results of a large study strongly suggest that cancer patients treated with "bisphosphonates" are at increased risk for the destruction or "osteonecrosis" of the jawbone, according to a study in the Journal of the National Cancer Institute ... But since 2003, physicians have reported more than 600 cases of jaw osteonecrosis that may have been caused by bisphosphonate use ... Evidence is growing that bisphosphonate treatment causes... (MEDLINEplus)
Down in the mouth? Jun 26, 2007
Bisphosphonates may place patients at risk for developing osteonecrosis of the jaws, which is irreversible damage in which the jaw bone rots away ... According to Dr. Svirsky, adverse affects from oral bisphosphonates will not show up until three years after the treatment starts, and after that time, the chance of developing osteonecrosis is still low ... In addition, there is a new screening tool now available that can help patients who have been taking an oral bisphosphonate for more than... (EurekAlert!)
Merck Sued in Ontario Court Over Fosamax Drug, Canadian Law Firm Says May 29, 2007
Use of the drug has been linked to an increased risk of developing osteonecrosis, also known as ``jaw death,'' according to the Canadian law firm ... Fiona Peters, 45, the lead plaintiff, took the drug between October 2001 and August 2004 and was diagnosed with osteonecrosis of the jaw last year, according to the complaint. (Bloomberg -- Canada)
Fosamax class action commenced in Canada May 28, 2007
Use of Fosamax has been linked to an increased risk of developing Osteonecrosis of the jaw ("ONJ"), also known as "jaw death". ONJ can be extremely painful and can cause jaw bones to rot and die. (Canada Newswire)
Experts Outline Use of Bisphosphonates Against Myeloma May 25, 2007
Risks associated with bisphosphonates include reduced kidney function, acute kidney failure and osteonecrosis (bone loss or deterioration) of the jaw. Among the recommendations included in the new guidelines. (MEDLINEplus)
Hannan’s Miller battles back from rare disease May 14, 2007
It s a disease that affects 1 in 1200 children, and of those afflicted, about three of four are boys, according to the National Osteonecrosis Foundation Web site (www. nonf. (Scranton Times, PA)
Tuesday's Stocks to Watch May 8, 2007
Aastrom Biosciences Inc. () said the Food and Drug Administration has approved its investigational new drug application to initiate a 120-patient Phase III clinical trial for the treatment of osteonecrosis, also known as avascular necrosis, of the femoral head. Osteonecrosis is a progressive disease, with no established effective treatments, that often leads to a total hip replacement. (Fox News)
New hope, concern on osteoporosis May 4, 2007
Another side effect, jaw osteonecrosis - jawbone death - has recently been recognized as a rare problem of certain bisphosphonates ... Last year, Merck estimated the risk of osteonecrosis to be less than one out of 100,000 patients per year. (Philadelphia Inquirer)
New method predicts hip joint decay from chemotherapy Apr 20, 2007
St. Jude study shows that the extent of hip decay is key to predicting which survivors of leukemia/lymphoma who develop osteonecrosis of the femoral head will suffer hip joint collapse requiring surgical repair ... The study is significant because the intensive use of corticosteroid drugs that have been implicated in development of osteonecrosis, or bone deterioration, is a major component of chemotherapy for pediatric leukemia and lymphoma ... Degeneration of this area, called osteonecrosis of... (EurekAlert!)
Side effect of jaw osteonecrosis Apr 16, 2007
Dear Dr. Donohue: After a bone density test, my physician prescribed Fosamax. I have heard that it has a serious side effect -- jaw decay. (Herald-Tribune)
Abbott Agrees With World Health Organization (WHO) Director-General to Expand Access to Kaletra/Aluvia (lopinavir/ritonavir) Apr 10, 2007
Although the etiology is considered multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy. At this stage of development, little information is available on the cross-resistance of viruses selected during therapy with Kaletra. (PR Newswire)
Overgrowth of gums, unexepected side effect of blood pressure med Mar 29, 2007
31) in which you spoke of a dentist recommending that the patient stop taking her blood pressure medication Norvasc due to the risk of bone loss to the jaw, the dental recommendation probably had more to do with the risk of gingival hyperplasia than osteonecrosis of the jaw ... While CCBs do not cause osteonecrosis of the jaw, nor do they directly cause bone loss, they can indirectly cause it if they're causing significant gingival hyperplasia. (Atlanta Journal-Constitution)
Body Parts: Femur is bone with the most ---- in a lot of categories Feb 25, 2007
The tissue then dies, causing osteonecrosis. Because bone is living tissue, osteonecrosis weakens it ... Osteonecrosis is most likely to occur in the femoral head. (North County Times)
BioMimetic drug on fast track for approval Feb 22, 2007
The product, called recombinant human platelet derived growth factor, attracts cells necessary for tissue healing in patients with Osteonecrosis of the jaw, which is characterized by pain, swelling and infection, loosening of teeth and exposed bone. The condition affects fewer than 20,000 people in the country. (Nashville Business Journal, TN)
Maple Hill students unite for classmate Jan 31, 2007
According to the National Osteonecrosis Foundation, Legg-Calve Perthes is a rare disease of the hip found only in children that afflicts approximately one in 1,200 children. Of those, only about one in four are girls. (Hillsdale Independent, NY)
Adult Stem Cells Spur Rush to Market as Remedies Avoid Bush's Embryo Ban Jan 11, 2007
Aastrom is also conducting trials that use stem cells in spinal fusion, jawbone reconstruction and a rare disease, osteonecrosis, which damages the hip and often leads to repeated hip replacements. The company plans to begin final-stage trials for osteonecrosis in the first half of this year. (Bloomberg)
Another drug to fight bone loss in men Dec 12, 2006
Actonel and Fosamax are bisphosphonates, a type of drug that has had the side effect of osteonecrosis, or bone loss, in the jaw, leading to loose teeth ... Osteonecrosis in the jaw occurs in about seven cases out of 1 million patients, according to the American Dental Association, and "is a minor issue that shouldn't influence anyone's decision about taking Actonel," Weinerman said. (Newsday -- Health)
Osteonecrosis of the Jaw — Do Bisphosphonates Pose a Risk? Nov 30, 2006
NEJM -- Osteonecrosis of the Jaw -- Do Bisphosphonates Pose a Risk ... Osteonecrosis of the Jaw Do Bisphosphonates Pose a Risk. (New England Journal of Medicine)
Suppressed Bone Turnover during Alendronate Therapy for High-Turnover Osteoporosis Nov 9, 2006
1 Although their safety has been tested in randomized trials (for up to 10 years),2 reports of previously unnoticed complications, such as severe suppression of bone turnover3 and osteonecrosis of the jaw,4 have emerged with long-term use. A 35-year-old man was referred to our Bone Health Program in 1996 because of wrist and pelvic fractures after mild trauma. (New England Journal of Medicine)
Osteoporosis Medications May Lead To Bone Problems Oct 28, 2006
The condition is called osteonecrosis of the jaw, or ONJ. Essentially, the bone dies ... "People taking the oral form for the bisphosphonates are at very low risk to develop this osteonecrosis," said Steinberg ... Some experts believe exposure may be key, and say the risk of osteonecrosis may go up the longer you take the drug. (CBS2Chicago.com, IL)
Saturday event to benefit Bluffs native Zuehlke Oct 5, 2006
A Lewis Central graduate, Zuehlke, 35, has been diagnosed with osteonecrosis, a disease that involves the destruction of bone tissue, often as the result of a loss of blood flow. It most commonly affects the bones and joints of the hips. (Council Bluffs Daily Nonpareil, IA)
Drug used for advanced cancer could cause exposed bone in jaw Oct 3, 2006
The condition, called osteonecrosis of the jaw, is marked by exposed bone in the jaw and can lead to infection, inflammation and pain. While researchers do not fully understand the condition or what causes it, osteonecrosis of the jaw, or ONJ, appears to occur in individuals who have been treated with drugs called bisphosphonates, which are used to improve bone strength ... "Osteonecrosis of the jaw is not a common condition. It appears to occur in 1 percent to 10 percent of patients with... (EurekAlert!)
Encouraging Sign For Long-term Safety Of Bisphosphonates Sep 22, 2006
(December 30, 2004) -- Doctors at Long Island Jewish (LIJ) Medical Center recently discovered a link between a common chemotherapy drug and a serious bone disease called osteonecrosis of the jaw (ONJ). The discovery. (Science Daily)
Jawbone Trouble Rare with Osteoporosis Drugs Sep 3, 2006
Yet, since most of the problems have occurred among dental patients, experts say the best way to guard against osteonecrosis, or the death of jawbone tissue, is to avoid having to undergo procedures such as dental extractions and implants ... The first reports of osteonecrosis among users of the intravenous bisphosphonate, Zometa, appeared in 2003, according to a report from the American Dental Association ... The reason for the association between the bisphosphonate drugs and osteonecrosis is... (MEDLINEplus)
Mayo Clinic: New recommendations for use of bisphosphonates in treatment of multiple myeloma Aug 11, 2006
Unfortunately, along with the positive effects of bisphosphonates comes the possibility of adverse reactions, including kidney function impairment and damage to the jaw bones termed "osteonecrosis of the jaw." "We have tried to balance the undisputed benefits of bisphosphonates with the increasingly well recognized safety concerns," said Vincent Rajkumar, M.D., Mayo Clinic hematologist and co-author. "These recommendations are the result of years of practical knowledge combined by our team into... (EurekAlert!)
Oral bisphosphonate risk slight, but dental patients should be aware, ADA says Aug 5, 2006
Relying on a small but growing number of reports linking bisphosphonate drugs to incidences of osteonecrosis of the jaw (dead bone tissue), a panel of experts convened by the ADA believes dental patients who are taking oral bisphosphonate drugs should discuss the risks they face when undergoing procedures that involve the jaw bone, such as tooth extraction or placing implants, with their dentist ... Further, patients should understand that the risk for developing osteonecrosis of the jaw is... (EurekAlert!)
Systemic zoledronate treatment both prevents resorption of allograft bone and increases the retention of new formed bone during revascularization and remodelling.A bone chamber study in rats. Aug 5, 2006
In osteonecrosis the vascular supply of the bone is interrupted and the living cells die ... If the osteonecrosis occur in mechanically loaded parts, like in the subchondral bone of a loaded joint, the remodelling might lead to a weakening of the bone and, in consequence to a joint collapse ... This might be useful in bone grafting procedure but also in other orthopedic conditions, both where necrotic bone has to be remodelled i.e. after osteonecrosis of the knee and hip and in Perthes disease,... (BioMed Central)
Boomers boosting rise in hip, knee replacement Aug 1, 2006
The condition, known as osteonecrosis, forced professional football and baseball player Bo Jackson to undergo hip replacement surgery in 1992. But most people who get a joint replaced have osteoarthritis, a degenerative condition resulting from the gradual loss of bone-cushioning cartilage within the joints. (Sun-Sentinel.com)
Danger in osteoporosis medicines? Jul 31, 2006
Danger in osteoporosis medicines. Dear Dr. Donohue: Lately, on television, they have been telling women about the terrible side effects to the jawbone that Fosamax and Actonel create. (Herald-Tribune)
Hip replacement surgery a winner for many patients Jul 28, 2006
" The No. 1 reason people seek hip replacement surgery is to treat the pain associated with osteoarthritis, which is a disease that causes the body to wear down as a person ages, he said. Others, like Floyd Landis, seek the surgery because of pain associated with osteonecrosis of the hip. Mr. Landis damaged his hip in a biking accident and complications from that injury led to osteonecrosis of the hip. In patients with osteonecrosis of the hip, blood vessels gradually cut off nourishment to the... (Quad-Cities Online)
Landis' Medical Condition Often Linked to Steroid Use Jul 28, 2006
Steroid Use Is a Risk Factor in Osteonecrosis ... He suffers from osteonecrosis, or avascular necrosis, in his right hip ... Bone fractures are the biggest risk factor in developing osteonecrosis. (ABC News)
Floyd Landis' Hip Battle Jul 27, 2006
That pain is the result of osteonecrosis -- also known as avascular necrosis (AVN) ... What Is Osteonecrosis ... Osteonecrosis develops when blood vessels that feed bones are injured, destroyed, or blocked. (CBS News)
Rise and Shout: Floyd Landis: American sports hero Jul 27, 2006
As a result of the crash, he was diagnosed with osteonecrosis, a disease where the bone and marrow die in the absence of an invective agent. In Landis's case, the ball of his right hip was deteriorating and the only way to fix it would be to have hip replacement surgery. (The Daily Universe, UT)
Can Landis Pull a Lance Comeback? Jul 26, 2006
The cyclist has osteonecrosis in his right hip, also called avascular necrosis, in which the ball of the hip joint has lost its blood supply, causing the bone to wear down ... After the surgery, Landis should no longer suffer the daily pain of osteonecrosis. (ABC News)
Landis On Verge Of Victory Jul 23, 2006
Landis is in constant pain from a bone disease called osteonecrosis in his right hip, reports CBS News correspondent Randall Pinkston. The hip has been drilled with small holes to help renew the blood flow, and later this summer, Landis plans to get a hip replacement. (CBS News)
Floyd Landis Bikes Through the Pain Jul 22, 2006
Tour de France Front-Runner Has Osteonecrosis. Floyd Landis suffers from a painful condition called osteonecrosis ... Landis has osteonecrosis, which means that not enough blood gets to his right hip, so the ball of that joint has shriveled like a hunk of rotting driftwood. (ABC News)
From the Press Box Jul 20, 2006
Armstrong (Landis) is an inspiring story, having endured testicular cancer that spread to his lung and brain (suffering from osteonecrosis in his hip). Armstrong (Landis) required powerful treatment to even survive to compete in the Tour de France (will need hip replacement surgery when this is over). (USA Today -- Sports)
Gearing up suits claiming Fosamax risks Jul 11, 2006
Researchers agree that the incidence of this problem, called osteonecrosis, is quite small ... "Osteonecrosis is very rare and not well understood," Irvine said, noting that in controlled clinical trials involving more than 17,000 patients, there had been no reports of the malady. (Newsday -- Health)
If taking medication, tell your dentist Jun 21, 2006
A rare side effect of the biphosphonate class of drugs, which has recently been discussed in medical publications, is something called osteonecrosis of the jaws (ONJ). This side effect arises out of the mechanism of action of the drugs. (Auburn Citizen, NY)
Treatment Drug May Cause Jawbone To Die Jun 14, 2006
Bisphosphonates may place patients at risk for developing osteonecrosis of the jaws (a rotting of the jaw bones), according to a case report and literature review that appeared in the May/June 2006 issue of General Dentistry, the Academy of General Dentistry s (AGD) clinical, peer-reviewed journal ... She then developed osteonecrosis in her upper and lower jaws following tooth removal ... This type of osteonecrosis has been occurring since the advent of these drugs, explains co-author Wellington... (Science Daily)
Jawbone Trouble Linked to Class of Drugs Apr 19, 2006
They're being linked to osteonecrosis or rotting of the jawbone in some patients. Dr. Len Lausten says the UMKC School of Dentistry has seen 12 cases, all in people taking the i-v form. (FOX4 Kansas City, MO)
Health Highlights: April 13, 2006 Apr 14, 2006
charges that Fosamax is a defective product because it can cause rotting of the jaw bone (osteonecrosis), the Associated Press reported ... In a statement, the company said that in all of its clinical trials of Fosamax, there were no reports of osteonecrosis of the jaw ... While there have been reports of osteonecrosis in patients taking Fosamax, that doesn't mean the drug caused it, the statement added. (Forbes)
Suit Alleges Merck Negligently Promoted Osteoporosis Drug Fosamax Apr 13, 2006
Fosamax is a defective product because it can cause osteonecrosis of the jaw, or a rotting of the jaw bone ... In a statement, Merck said that in all of its clinical trials of Fosamax, which have included more than 17,000 patients, it has not had any reports of osteonecrosis of the jaw. (Law.com)
Serious oral post-surgical complication identified in patient on prescribed therapy for osteopenia Apr 12, 2006
Patient who received IV bisphosphonates associated with treatment for breast carcinoma develops osteonecrosis following periodontal surgical therapy. Chicago The patient of a periodontist in private practice in New Orleans developed osteonecrosis of the jaw (ONJ), a condition that can cause severe, often irreversible and debilitating damage to the jaw, following periodontal surgical therapy ... Additional information about IV bisphosphonates and osteonecrosis is available through the Academy's... (EurekAlert!)
Bone drugs' reverse danger Apr 4, 2006
Christopher Loder, a spokesman for Fosamax maker Merck, points out that osteonecrosis of the jaw with Fosamax is "exceedingly rare." "In all of our controlled clinical trials with Fosamax, which involved more than 17,000 patients, including some that were 10 years in duration, we had no reports" of it, he says ... The rare side effect, called osteonecrosis of the jaw, causes severe infections, swelling and the loosening of teeth. (Los Angeles Times)
New Study Shows Women With Osteoporosis Preferred Once-Monthly Dosing of Boniva Over a Once-Weekly Medicine Mar 17, 2006
Additionally, osteonecrosis of the jaw has been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures. The most commonly reported adverse events with once-monthly Boniva regardless of causality were abdominal pain (Boniva 150 mg 7. (PR Newswire)
Aastrom Biosciences, Inc. Reports Second Quarter Fiscal Year 2006 Financial Results Feb 8, 2006
"The proof of concept results we are gathering from our studies are very encouraging for the prospects of our TRC bone marrow stem cells to regenerate human tissues in certain clinical indications." Dr. Armstrong continued, "We have also continued to make progress in our pipeline programs as we explore extending the use of TRCs to specific clinical indications and different human tissues. This is illustrated by our new clinical trial in which diabetic patients receive TRCs to potentially... (PR Newswire)
