Fosamax

Have you been taking prescribed Fosamax? Have you been taking any bisphosphonates to treat for osteoporosis? You may be at risk for severe femoral fractures from low-impact injuries, or a potentially deadly form of osteonecrosis of the jawbone.

What Is Fosamax?

Fosamax (Alendronate) was released by Merck & Co. in 1996. It’s primary function is to increase bone density. The drug is in a category known as nitrogenous bisphosphonates. Other drugs that fall into this category are used for various treatments such as chemotherapy.

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Fosamax is available only when prescribed by a licensed physician, and only in the amount and frequency instructed by the prescribing physician. Prior to use, the patient is warned about potential side effects that can include chest pain, difficulty or pain when swallowing, pain beneath the ribs or in the back, jaw pain, numbness or swelling of the jaw, heartburn, joint pain, or headaches. The patient may be told of similar drugs in the same class believed to have caused breakdown of the jaw bone, or Osteonecrosis.

After the publication of research in 2002 by the Women’s Health Initiative related to the high incidence of serious cancer risks related to estrogen therapy, previously the primary treatment and prevention option for osteoporosis, sales of drugs like Fosamax skyrocketed, and by early 2006, nearly ten million Americans were taking Fosamax.

But in 2004, the FDA issued a request that Merck & Co. change its warning label to include more aggressive warnings of the risks of osteonecrosis due to regular Fosamax use. This initial change to the warning label was due to the discovery there was a significant increase in the number of cases of osteonecrosis of the jawbone. Novartis Oncology, another maker of this class of drugs, with the trade names Aredia and Zometa, issued their own letter to prescribing physicians to further emphasize this concern. But in 2010, the FDA issued a much broader warning related to the implication of the use of bisphosphonates:

“Since Fosamax was approved on September 29, 1995, we have become aware of a possible increased risk of atypical subtrochanteric and diaphyseal femoral fractures in patients taking bisphosphonates, including Fosamax, for the treatment and/or prevention of osteoporosis.”

Unacceptable Side Effects

Numerous studies prior to the issuance of this warning label change examined the specific issue of femoral fractures among the elderly population at risk for osteoporosis, and concluded the risk levels are very high when compared to people not taking this class of drugs. Two separate studies by researchers from Hospital for Special Surgery (HSS) and Columbia University Medical Center revealed data suggesting that long-term suppression of bone remodeling by bisphosphonate treatments may alter the material properties of bone, potentially affecting the bone’s mechanical integrity and potentially contributing to the risk of atypical fractures.

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“Although bisphosphonates have demonstrated an improvement in bone quantity, little if anything is known about the effects of these drugs on bone quality,” said Brian Gladnick, BS, representing a team of investigators at HSS in New York.

(From the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS)

The current FDA-required warning label for all drugs in this class reads in part:

Atypical Subtrochanteric and Diaphyseal Femoral Fractures:

Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with bisphosphonates.

Atypical femur fractures most commonly occur with minimal or no impact to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g. prednisone) at the time of fracture.

Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out a femur fracture. Subjects presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of bisphosphonate therapy should be considered, pending a risk/benefit assessment, on an individual basis.

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Numerous lawsuits have been filed across the country against Merck & Co. over the very types of serious fractures described by the above-cited research. Several are seeking class-action status. The Cartwright Law Firm has been at the forefront in protecting consumers against drug company excesses that have injured and often killed patients who took prescription drugs that their doctors believed, based on the claims made by these same drug companies, would help, and not harm, their patients. In recent years, an increasing number of drugs brought to market have been recalled or taken off the shelf due to the threat of dangerous side effects.

Recognizing the danger posed by some of these drugs, The Cartwright Law Firm, located in San Francisco, California, brought its first Vioxx case to court 2 years before any others were filed in the state of California. We’re also the first law firm to go to trial over dangers posed by Viagra. Unfortunately, there are a number of other drugs that have caused injury or death for those that have used them. Prepared with medical experts and knowledgeable in regard to the complicated issues involved in pharmaceutical cases, our personal injury attorneys know how to prepare cases involving dangerous drugs such as Fosamax.

Restoring The Balance Of Power

We realize dangerous drug cases involve big pharmaceutical companies. Even so, our personal injury lawyers have taken them on before and won. And, in the case of Merck and Fosamax and other bisphosphonates, just as with Merck and our lawsuits regarding Vioxx, a public record already exists indicating the dangers these drugs pose to innocent users of them. Don’t be intimidated – we have the knowledge and expert resources to balance out the power and put the law on your side.

Whether you live in Oakland, San Mateo, Santa Rose, Sacramento, or San Jose, or anywhere in the State of California, we can help you hold drug manufacturers liable for their dangerous products. We offer free consultations and recover our attorneys fees as a percentage of any settlement awarded our clients. Contact a San Francisco dangerous drug attorney today and hold those accountable who gambled not only with your life but with countless other lives as well.