Fosamax Osteonecrosis Lawyer
Fosamax News
ICARO STUDY SHOWS CLINICAL BENEFITS OF FOSAMAX ARE OVERSTATED
Category: Fosamax News
An article recently published in the Journal of Bone & Mineral Research, Fracture Incidence & Characterization in Patients on Osteoporosis Treatment: The ICARO Study, shows that the clinical trials Merck touts overstate the actual benefit conferred by Fosamax in the clinical or practical setting. The article is published in the October 2006 edition of the Journal, at pages 1565-1570.
I found it very curious that there was poor fracture reduction response for patients on Fosamax unless they were also taken Vitamin D and calcium supplements. Could it be that the Vitamin D and calcium supplements are what is helping patients rather than the Fosamax? Studies published in the New England Journal of Medicine show that Vitamin D and calcium supplements, taken by themselves, do have a significant effect on decreasing fractures.
It would be very interesting to see a head-to-head comparison of alendronate (Fosamax) therapy by itself to Vitamin D + calcium supplements to see which one is more effective at reducing fractures.
The attorneys at Levin Papantonio will be examining these questions with Merck over the next several months.
Merck Admits Knowledge Of Reports Of ONJ
Category: Fosamax News
Rather than warn patients, and despite knowledge known by Merck about the increased risk of osteonecrosis of the jaw on patients using Fosamax, Merck has yet to issue a "Dear Doctor letter" to prescribing physician, and continues to defend Fosamax by minimizing unfavorable findings through statements such as those made in the Wall Street Journal: "'The cause of osteonecrosis is not well understood and is likely to include a number of conditions.'"
Additionally, while there has been no Merck clinical study directed to the relationship of osteonecrosis of the jaw and Fosamax use, Merck infers that the fears of ONJ are unfounded by arguing "'in all our controlled clinical trials, including the 10-year data with Fosamax, which have included more than 17,000 patients, we have not had reports of osteonecrosis of the jaw occurring in patients taking Fosamax.'"
However, in direct contrast to that statement, Merck has informed the American Dental Association that it is aware of at least 170 reports of osteonecrosis in Fosamax users. So, how has Merck been able to avoid the problems with Fosamax that it faces with Vioxx? And will it continue to be able to do so?
When examining this issue, we should consider the following factors:
(1) The peer-reviewed literature appearing in dental and oral surgery journals clearly establishes the relationship between Fosamax and ONJ;
(2) Most physicians who prescribe Fosamax do not read dental and oral surgery journals;
(3) In its prescribers information, Merck has not issued any warnings about Fosamax and the risk of ONJ to prescribing physicians;
(4) Merck has done no "Dear Doctor" letter to prescribing physicians advising them of the risk of ONJ linked to Fosamax use;
(5) Merck has made public statements inferring to prescribing physicians that there is no risk of ONJ with Fosamax;
(6) Merck previously has been rebuked by the Food & Drug Administration for misleading the public about the risks of another Merck blockbuster drug, Vioxx.
(7) Merck has been rebuked by the FDA for overstating the efficacy of its drug Fosamax.
The time has come for Merck to acknowledge what the leading dental organizations have already acknowledged: Fosamax causes osteonecrosis of the jaw.
American Dental Ass'n: Fosamax Causes ONJ
Category: Fosamax News
An expert panel put together by and for the American Dental Association recently formally recognized that the use of Fosamax is a risk factor for osteonecrosis of the jaw. This panel was comprised of several of the leading experts in the areas of oral surgery and dentistry from around the nation.
Injury Rate Estimates
Category: Fosamax News
Because treatment can be beneficial, everyone is keeping a close eye on the rate of ONJ related to drug treatment.
About 1,600 bisphosphonate-related ONJ cases have been reported to the FDA as of Oct. 28, said the American Association of Oral and Maxillofacial Surgeons.
The condition is rare. Between 6 percent and 8 percent of those taking bisphosphonates intravenously develop ONJ at the current dosages, doctors estimated. The damage from ONJ is permanent for these intravenous bisphosphonate users.
"The damage is so severe, the bone does not recover," one doctor said.
Bisphosphonate-induced ONJ is even more uncommon for those taking the medicine orally, such as with Fosamax. One oral surgeon has estimated the frequency at .05 percent to 0.005 percent.
Fosamax Lawsuit Brings Dangers To Light
Category: Fosamax News
A recent article appeared in the Salt Lake City Tribune, detailing the struggles of a Utah Fosamax patient who is dealing with osteonecrosis of the jaw. The article was written by Carey Hamilton, who did a superb job covering the issue.
Doctors Concerned About Fosamax And Osteonecrosis
Category: Fosamax News
A recent article appeared in the New Jersey Star-Ledger detailing the concerns that physicians and patients have about Fosamax's ability to cause osteonecrosis of the jaw.
As I discuss in the article, you'd have to be the Amazing Karnac to interpret the thinly worded osteonecrosis "precaution" Merck put into its Fosamax label in late 2005.
Fosamax Patients Need to Be Aware of Risks
Category: Fosamax News
With more than 44 million Americans suffering from osteoporosis, it is important to stay informed about the risks of drugs that treat this bone loss problem. A May 20 article in the South Florida Sun-Sentinel expresses the concerns many doctors have over the popular drug Fosamax for their osteoporosis patients.
Continue reading "Fosamax Patients Need to Be Aware of Risks"
NIH To Conduct Study On Fosamax's Dangers
Category: Fosamax News
I was recently interviewed by the Sun-Sentinel, the major paper in South Florida. I was pleased to learn through that process that the National Institutes of Health has decided to spend some effort and money studying Fosamax and its relationship to adverse events. If you'd like to read the article, here's the link: Fosamax dangers. We continue to file cases on behalf of injured Fosamax patients and look forward to litigating these cases to their successful conclusions.
Fosamax Firm Investigates ReNu Problems
Category: Fosamax News
As my Fosamax team is conferencing with clients, reviewing medical records, preparing lawsuits, interviewing witnesses, meeting with expert dentists and oral surgeons, I was pleased to learn that my very able partners were hard at work investigating claims relating to Bausch & Lomb's ReNu MoistureLoc contact lens solution. Levin Papantonio, has filed suits in Florida and Georgia on behalf of injured MoistureLoc users.
This contact lens solution has been linked to the potentially blinding eye infection, fusarium keratitis. This infection can lead to severe optical injuries resulting in corneal transplants and, in severe cases, blindness. The problems with the contact lens solution appears to be that the antifungal agent used by Bausch & Lomb is insufficiently powered to take care of fungal agents. MoistureLoc has not been completely withdrawn from the market.
MoistureLoc patients who believe that they have developed a problem should see a doctor immediately, preserve the product packaging, and any proof of purchase. For questions concerning your legal rights, please contact me for a free consultation.
Fosamax, Osteonecrosis, And The Net
Category: Fosamax News
It's interesting, if you look at the internet, you can see in the Wikipedia that Fosamax causes osteonecrosis of the jaw. Look at the following link: http://en.wikipedia.org/wiki/Fosamax This summary very fairly reflects the current state of the peer-reviewed medical/dental literature. . Just like with Vioxx, the common wisdom appears to have far outpaced the information provided by Merck toAt the same time, no such language appears in Merck's Fosamax warnings provided to physicians and patients. For more information about the risks of osteonecrosis and Fosamax, please feel free to contact me.
Law Radio Interview Of Tim O'Brien Re: Fosamax
Category: Fosamax News
I had the pleasure of being interviewed for 30 minutes on Law Radio's show, Coast to Coast. You can get the download at http://www.law.com. Also, you may contact me if you need further information pertaining to what we're seeing with Fosamax cases and osteonecrosis of the jaw. Understandably, there a lot of concerned patients out there. If any dentist or doctor is reading this and wants to see the literature explaining the risks, please feel free to contact me.
Cnn Reports On Fosamax Lawsuit
Category: Fosamax News
CNN MONEY recently ran a story on the Fosamax lawsuit.
Could this be another Vioxx? The plaintiffs in approximately 11,500 lawsuits blame the arthritis painkiller for causing their heart attacks, and accuse Merck of withholding information about the drug's health risks. Merck has said all along that Vioxx didn't kill anyone and denied all charges of corporate wrongdoing.So far, Merck has lost two cases, won two, and there was a split verdict in another. The next trial begins June 5, in a case involving two plaintiffs in a New Jersey state court in Atlantic City.
Fosamax's Mechanism Of Action
Category: Fosamax News
I have been interviewed by several news agencies about Fosamax and its relationship to osteonecrosis of the jaw. Time and again, the question is asked: "Why can something which helps prevent bone loss in the hips and thighs cause bone problems in the jaw?" In researching this issue, it is apparent that the same mechanism which makes an oral bisphosphonate like Fosamax an osteoporosis hero, also makes it an ONJ villain. The process by which Fosamax works in preventing osteoporosis is by the inhibition of osteoclasts; by inhibiting osteoclasts, bisphosphonates inhibit bone material from being resorbed (or removed) by osteoclasis.
Normal osteoclasis is vital to bone turnover and the ability of the bone to survive Interruption of this homeostatic cycle by inhibition of bone resorption results in micro fractures of the old mineral matrix and impairs the jawbones' ability to repair themselves. This process also impairs the growth of veins in the jaw bones which in turn inhibits the ability to heal and fight infection.
Marked inhibition of bone remodeling which occurs on bisphosphonate therapy predisposes patients to osteonecrosis, particularly since the jaw has exposed bone and the mouth is never aseptic. Because the jaw bones are the only bones in the human skeleton constantly exposed, (through the teeth), frequent "bone turnover" is imperative to the maintenance of healthy jaw bones. In other words, the jaw bones need constantly to purge the old and bring in the new bone material. Osteoclast inhibition, prevents the purging of the old - - which makes it effective for preventing osteoporosis - - but also doesn't allow the exposed bones in the jaw to bring in the new.
The question presents itself: why does a drug which helps reduce fracture rates in long bones cause such problems in the jaw bones? In his 2005 article, Bisphosphohonate Induced Expose Bone of the Jaws, University of Miami Professor Robert E. Marx answers as follows: "Because the jaws have a greater blood supply than other bones and a faster bone turnover rate related both to their daily activity and the presence of teeth (which mandates daily bone remodeling around the periodontal ligament), bisphosphonates are highly concentrated in the jaws. Coupled with chronic invasive dental diseases and treatments and the thin mucosa over the bone, this anatomic concentration of bisphosphonates causes this condition to be manifested exclusively in the jaws."
Additionally, as a result of the presence of the nitrogen atom on the alendronate chemical chain, Fosamax has a half-life of more than ten years which can result in a massive cumulative dose over the multi-year dosing cycle. Due to this long half-life and the nature of the osteonecrotic process, the progress of the disease occurs even after discontinuation of Fosamax therapy.
Unfortunately for the patient suffering from osteonecrosis, there is no known effective treatment for this drug induced osteonecrosis. Indeed, corrective oral surgery may actually exacerbate the problem. Thus, the need to prevent the disease or catch it in its early stages is apparent.
Docs Need To Understand Fosamax Risks
Category: Fosamax News
It is clear from me, based upon the calls I get from clients, that prescribing physicians usually do not know about the August 2004 FDA adverse event database review in which the FDA concluded that the risk of osteonecrosis was a class effect of nitrogenous bisphosphonates, including Fosamax. This is the problem with this particular risk factor because most of the literature appears in dental journals and oral surgery journals - - journals not usually read by the internal medicine doctors, rheumatologists, endoctrinologists, etc. who actually prescribe Fosamax. In one fo the more recent articles, authored by renowned oral surgeon Dr. Robert E. Marx reveals that this is a problem extending to Fosamax: "Given that it has a half-life of more than 10 years, the current widespread use of alendronate (Fosamax) to prevent or treat early osteoporosis in relatively young women and the likelihood of long-term use as well as the unbiquitous presence of dental disease in our society gives us cause for concern." J. Oral Maxillofac Surg. 63:1567-1575 (2005), at p. 1575. If anyone reading this blog is a prescribing M.D., please feel free to contact me and I'll be happy to share this info with you.
Fosamax Interview From New York Times
Category: Fosamax News
I was recently interviewed by NYT writer Alex Berenson for an article about current drug litigation. I spoke about Fosamax and Ortho Evra litigation and noted that Dead Jaw is very rare as are blood clots in women of child bearing age, so the link to these drugs seems to be more clear than in Vioxx litigation.
Read the complete drug lawsuit article.
What is Osteonecrosis?
Category: Fosamax News
Osteonecrosis means "dead bone" and occurs when a bone dies from decreased blood loss.
Pain, both at rest and, in particular, with movement of the joint is the major symptom of osteonecrosis. Other symptoms include limitation of motion, joint stiffness and muscle spasms. Symptoms usually begin slowly. If the condition is left untreated, progressive bone damage (bone collapse) may occur, which can be associated with an increase in pain and loss of function of the joint. Surgery may be required to correct this damage.
Merck Hid Fosamax Dead Jaw Info From Doctors
Category: Fosamax News
Tom Lamb over at Drug Injury Watch has a great post notifying readers about Merck witholding Fosamax Osteonecrosis information from doctors. Tom also mentions that the FDA recommended Merck change Fosamax's label to include Osteonecrosis warnings in 2004. However the company didn't revise packaging info until July 2005.