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Bisphosphonates Risks

Searcy Denny Fights for Justice for Injured Patients Across the United States

Searcy, Denney, Scarola, Barnhart & Shipley, P.A. has more than 40 years of experience recovering compensation for victims of pharmaceutical defects.  Our Mass Tort Unit represents injured patients in multidistrict litigation (MDL) against large multinational drug corporations.  We have the resources, knowledge and determination to fight for justice for our clients.

Bisphosphonates Litigation

From our office in Florida, our firm is currently filing lawsuits against manufacturers of bisphosphonates in MDL in New Jersey and California.  MDL allows us to consolidate procedures, discovery, hearings and preparations in one court to streamline the recovery process for our clients.  We have already filed dozens of cases for clients in Florida and throughout the United States in the federal courts responsible for adjudicating the bisphosphonates MDL.

How Bisphosphonate Treats Bone Disease

Bisphosphonate is prescribed to treat osteoporosis.  Bones naturally go through cycles of disintegration — also called resorption — and formation.  Bone loss occurs when resorption happens faster than formation.  Bisphosphonates reduce the speed at which bone disintegrates, and thus, increases bone density and strength.  The medication is absorbed by bone matter and therefore affects patients long after they discontinue its use.

Tampering with the normal bone rebuilding cycle has backfired for many patients.  Over the long-term, use of bisphosphonates may actually weaken bones and subject patients to risks of serious injuries and diseases in addition to osteoporosis.

Brands of Bisphosphonates

Bisphosphonate-containing medications are sold under several brand names, including:

  • Fosamax
  • Fosamax Plus D
  • Actonel
  • Actonel with Calcium
  • Boniva
  • Atelvia
  • Reclast

In addition, these drugs are also available in generic formulations.  Depending on individual circumstances, health care professionals may administer bisphosphonate drugs orally or intravenously.

Health Risks Associated with Bisphosphonate

Searcy Denney is currently investigating the health risks associated with bisphosphonate.  We remain up-to-date on the latest studies about the osteoporosis medication and the FDA’s and the manufacturers’ responses to negative data.  To date, our firm has accumulated substantial information about a long list of known health risks linked to the drug, including atypical femur fractures, osteonecrosis of the jaw, musculoskeletal pain, kidney impairment, irregular heartbeat, esophageal cancer and eye inflammation.

Long-term use of the osteoporosis medication appears to increase risks of medical complications.  However, neither the FDA nor the manufacturers have defined a safe duration of use.

Femur Factures Linked to Bisphosphonate

Bisphosphonate is supposed to build stronger bones and prevent fractures.  However, in a bizarre twist, the drug may instead cause broken femur bones in patients who have taken bisphosphonate long term.  Subtrochanteric and diaphyseal femur fractures are rare in the general population and yet have predominately occurred in patients taking bisphosphonate.

The FDA issued a Drug Safety Communication to alert the public about risks of atypical thigh fracture in 2010.  The bisphosphonate products’ labels now indicate the risk of fracture in the warnings and precautions section of the package.  The FDA also released a Limitations of Use statement that describes the uncertainty about the optimal amount of time for taking bisphosphonate-containing drugs.

Osteonecrosis of the Jaw Caused by Bisphosphonate Use

The FDA has required warning labels about severe jaw decay on bisphosphonate products since 2002.  Osteonecrosis of the jaw (ONJ) can result in:

  • Infection
  • Ulcers
  • Exposed bone
  • Localized pain
  • Periodontal swelling and inflammation
  • Loose teeth

Patients who undergo dental procedures — such as tooth extraction, dental implant surgery or periodontal operations — while taking bisphosphonate are most at risk.  ONJ adversely affects quality of life and can be fatal.

Bisphosphonate Patients Experience Severe Musculoskeletal Pain

In 2008, the FDA alerted doctors to the potential severe muscle, joint and bone pain that patients may experience while taking bisphosphonate-containing medications.  Onset of the chronic pain may happen within days, months or years of the first dose of bisphosphonate and may continue even after the patient stops taking the drug.  For some patients, the pain never resolves.  Many patients describe such severe, debilitating pain that they cannot engage in normal activities of daily living.

Kidney Impairment Resulting from Bisphosphonate Use

The drug is eliminated through the kidneys and has been tied to renal complications and failure.  The latest Reclast label addresses renal toxicity and contraindicates use of the osteoporosis medication in combination with diuretics and other kidney medications.  Researchers suggest doctors monitor creatinine levels in patients to detect renal impairment in patients using bisphosphonate-containing pharmaceuticals.

Bisphosphonate May Cause Irregular Heartbeat

A University of Washington study concluded that risk of developing atrial fibrillation, a chronic irregular heartbeat, doubled with Fosamax use.  An irregular heartbeat generally causes dizziness and fatigue and can cause blood clot or stroke.

Increased Esophageal Cancer Risks from Bisphosphonate

Two epidemiologic studies that draw from the same U.K.  General Practice Research Database (GPRD) found conflicting results regarding the impact of bisphosphonate on risk of esophageal cancer.  One concluded no relationship, whereas the other determined that patients who received 10 or more doses, or who took the drug for more than three years, were twice at risk of contracting esophageal cancer.

No Warnings About Bisphosphonate-Related Eye Inflammation

A Canadian study found that bisphosphonate increased risk of serious inflammatory eye disease.  Patients may make a full recovery with early detection.  However, doctors and patients may not make the connection because the risks are not included on the label.

Common Side Effects of Bisphosphonate

Patients may also experience common uncomfortable bisphosphonate side effects, including:

  • Flu-like symptoms
  • Fever
  • Fatigue
  • Bone and muscle pain
  • Stomach upset
  • Anemia
  • Drop in calcium levels (hypocalcaemia)

Although these symptoms may dissipate after the first dose, patients should be aware that they could indicate a more serious problem.  For example, patients often complain of pain and aching in the thigh during the months immediately prior to sustaining a sudden femur fracture.  Also, doctors may assume that the underlying osteoporosis is causing a patient’s severe chronic pain when, in fact, the bisphosphonate is the real culprit.

Recover Damages for Injuries You Suffered After Taking Bisphosphonate

You may be able to obtain compensation for injuries caused by bisphosphonate use.  Call Searcy Denney at 800.780.8607 or contact our firm online to schedule a free assessment of your case.  Our medical products liability law firm represents clients across the country in pharmaceutical defect multidistrict litigation and dangerous drug use.

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"Nick DeBellis obtained the maximum recovery of full insurance limits in the case we worked on. He is a true professional and recommend him to anyone in South Florida."
Posted By: Michael Geoffroy