Osteoporosis Lawyer, Attorney, Law Firm - Florida and Nationwide

Florida Osteoporosis Drug Attorneys

  • Aclasta (zoledronic acid, Novartis)
  • Actonel (risedronate, Sanofi-Aventis/Proctor & Gamble)
  • Aredia (pamidronate, Novartis)
  • Atelvia (risedronate, Warner Chilcott)
  • Bondronat (ibandronate, Roche)
  • Boniva (ibandronate, Genentech/Roche)
  • Didronel (etidronate, Norwich/Proctor & Gamble)
  • Fosamax (alendronate, Merck)
  • Fosamax+D (alendronate + vitamin D3, Merck)
  • Reclast (zoledronic acid, Novartis)
  • Skelid (tiludronate, Sanofi-Aventis)
  • Zometa (zoledronic acid, Novartis)

Since 1995, millions of older women have been taking a class of drugs called bisphosphonates to stop the progression of osteoporosis – a condition that, after menopause, causes bones to thin and become brittle.

For post-menopausal women, osteoporosis can mean not only a disfiguring “dowager’s hump,” but, in advanced cases, can lead to fractures of the spine and hip. Bisphosphonates halt the progression of bone-thinning by preventing bones from losing calcium and other minerals that keep them strong. Some bisphosphonate drugs also are used to treat cancer patients with bone-threatening high blood calcium levels and victims of Paget’s disease, a painful disorder that weakens bones. Many bisphosphonates are taken orally, either in pill or capsule form; others are administered by injection or intravenously. They can be taken daily, weekly, monthly, or even once a year.

Evidence is now emerging that these drugs could pose health risks far worse than the conditions they prevent or treat. For one thing, these popular drugs have been prescribed to many women who did not suffer from osteoporosis, but instead had osteopenia – a loss of bone mineral density that is normal for most older women. However, not every woman who has osteopenia will develop osteoporosis.  

Manufacturers have been promoting long-term use of these osteoporosis drugs without investigating their potential long-term effects. As it turns out, because osteoporosis drugs have an unusually long half-life, they can remain a threat for as many as ten years after someone stops taking the medication. Recent studies cited by the Food and Drug Administration (FDA) indicated that women who had taken bisphosphonates for more than five years were at increased risk of atypical femur (thigh bone) fractures.  This newly-reported risk came on the heels of numerous reports of jaw osteonecrosis, esophageal cancer, and arrhythmia linked to osteoporosis drugs.

checklist

Recent research confirms what doctors are finding in more and more of their patients: This class of osteoporosis drugs is a serious threat to the health and safety of millions of people.

Here are four major risks of osteoporosis drugs of which patients should be aware in order to make informed healthcare choices:

  • Atypical subtrochanteric fractures (long-bone fractures), especially of the femur or thigh bone.  Many patients who suffered fractures experienced groin or thigh pain weeks beforehand; some broke their femur while doing something simple such as getting out of bed or stepping off a curb. In one study, a number of patients who had taken bisphosphonate drugs had fractured both legs.
  • Osteonecrosis (ONJ for short, sometimes called “bisphossy-jaw”), which means literally “death of the jawbone.” This is especially prevalent after major dental procedures, and requires extensive antibiotic therapy and/or surgery. Some cases call for having portions of the jaw resected (cut out surgically) and can result in long-term disability.

    Early symptoms of osteonecrosis include:

    • Swelling of the face
    • Pain and inflammation of the gums or oral tissue
    • Tooth loss
    • Serious infections
    • Drainage
    • Exposed bone
    • Altered sensations such as numbness
  • Esophageal cancer due to irritation of the esophagus (the tube that carries food and liquids from the mouth to the stomach). It has been theorized that inflammation of the esophagus is related to development of esophageal cancer. While the link has not yet been proven, the FDA has documented at least 68 cases of esophageal cancer in patients taking oral bisphosphonates – many of whom died. Early studies suggest that, especially with long-term use, patients taking these osteoporosis drugs face twice the risk of esophageal cancer than seen in the general population.
  • Arrhythmias such as atrial fibrillation.  In 2007, The New England Journal of Medicine reported that Reclast and Fosamax were implicated in two studies of women ages 65 to 89 years old, all of whom had osteoporosis and were treated with bisphosphonates. Although increased risk of atrial fibrillation was indicated – and is reflected in the Reclast warning labeling – the FDA has yet to acknowledge a clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation.

Doctors continue to over-prescribe these dangerous drugs and drug manufacturers continue to over-promote them. Yet, for at least ten years, ongoing research demonstrates the links between osteoporosis drugs and devastating injuries:

  • As early as 2003, a letter in The Journal of Oral Maxillofacial Surgerycalled osteonecrosis of the jaw “a growing epidemic.” Its author, Dr. Robert E. Marx, is Chief of Oral and Maxillofacial Surgery at the University of Miami. Dr. Marx detailed the condition of 36 patients with “painful bone exposure... unresponsive to surgical or medical treatments.” These patients had one thing in common: all had received bisphosphonates intravenously.
  • Just a few months later, in 2004, Dr. Salvatore Ruggiero of Long Island Jewish Hospital published a report of his findings: 63 patients with osteonecrosis of the jaw, 56 of them with cancer and 7 with osteoporosis. 
  • In October 2007, the FDA issued an Early Communication of an Ongoing Safety Review on Bisphosphonates, citing an alarming article and letter to the editor in the May 3, 2007, issue of The New England Journal of Medicine. The article and letter described two different studies suggesting increased rates of atrial fibrillation in older women with osteoporosis treated with Reclast or Fosamax. An updated safety review dated November 12, 2008, refers to a large study of zoledronic acid (also known as Zometa) showing “a statistically significant increase” in the rate of serious atrial fibrillation.
  • By June 2009, sufficient research had confirmed the danger of incapacitating bone, joint, and/or muscle pain in patients taking bisphosphonate drugs such as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa.  The FDA issued Information for Healthcare Professionals warning that “severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate.” These issues have now been addressed somewhat in product labeling, although many patients and their doctors remain unaware.
  • Recent FDA Drug Safety Communications cite observational studies linking subtrochanteric femur fractures and patients with osteoporosis being treated with bisphosphonates. In March 2010, the FDA recommended only that healthcare professionals be aware of these risks. In a safety update in October 2010, however, the FDA reported that although “it is not clear if bisphosphonates are the cause . . . these atypical fractures may be related to long-term bisphosphonate use.”

This information has been added to Warnings and Precautions in labeling of all bisphosphonate drugs approved for prevention or treatment of osteoporosis. In addition, the FDA required a new Limitations of Use statement in the Indications and Usage section of drug labels and a new Medication Guide to accompany prescriptions picked up at pharmacies.

(For links to current patient information and up-to-date labeling, click on the drugs listed individually at the beginning of this web page.)

While the FDA continues to await epidemiological studies for the dangers of osteoporosis drug use, many of the millions of patients ingesting bisphosphonates since 1995 are at serious risk. Unfortunately, little has been done to communicate this important safety information to patients, or to require Merck, Novartis, and other bisphosphonate manufacturers to fund proper studies to evaluate the long- term risks and the efficacy of this class of osteoporosis drugs.

Numerous lawsuits have been filed, and litigation efforts are being pursued in coordinated state and federal proceedings in New York, Pennsylvania, California, and New Jersey. Prior to 2010, a majority of these lawsuits were limited to Fosamax and the intravenous drugs Aredia and Zometa. Most of these involved patients who suffered osteonecrosis of the jaw before drug labels warned of those dangers. Since 2010, the litigation efforts have focused more on atypical long-bone or femur fractures linked to osteoporosis drugs. It is anticipated that future lawsuits will expand to include the full range of newer bisphosphonates, such as Boniva and Actonel, which have the potential to cause harm.

In the meantime, it is up to patients, especially post-menopausal women, to make informed decisions about osteoporosis drugs by:

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