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Fosamax

The Fosamax injury attorneys at the Drug Law Center represent clients who have suffered serious injuries or died through a wrongful death after taking the bone loss medication.

Introduction

Fosamax RecallFosamax (alendronate sodium) is a prescription medication used for the treatment and prevention of osteoporosis (bone loss) in adults. The drug increases the development of bone mass while slowing bone loss. Many women use Fosamax to prevent or treat menopausal-related osteoporosis. Older adults take the medication to prevent bone fractures and for the treatment of osteoporosis caused by steroid use including corticosteroids (dexamethasone and prednisone).

The History of Fosamax

The Food and Drug Administration first approved Merck & Company’s Fosamax and its generic form alendronate sodium in 1995 to treat menopausal-associated osteoporosis where bones become weaker. Eight million women in the United States are affected by the bone-weakening condition that is known to cause more than 1.5 million fractures in the U.S. every year.

The bisphosphonate drug has proven to be effective at treating bone diseases including osteogenesis imperfecta and osteoporosis. Merck offers the widely prescribed medication alone and combined with vitamin D. However, in 2008, the patent held by Merck on alendronate sodium expired. Since it was first launched decades ago, the medication has been used to treat a variety of conditions including:

  • Paget’s disease
  • Osteogenesis Imperfecta in men and women who are at least 18 years old
  • corticosteroid-associated osteoporosis
  • Male osteoporosis
  • Female osteoporosis as both a prophylaxis and treatment

Fosamax Side Effects

Brand-name Fosamax and its generic form alendronate sodium have been linked to leg fractures that break straight across the thigh bone that is often produced by little or no trauma. Other serious side effects caused by taking the medication include:

  • Esophageal cancer
  • esophagus alterations
  • atrial fibrillation
  • Infrequent skin rash
  • Scleritis (inflamed and swollen eyes)
  • Uveitis (uvea inflammation)
  • Toxic epidermal necrolysis
  • New or worsening heartburn
  • Osteonecrosis of the jaw
  • Skin blisters
  • Bloody stools
  • Chest pains
  • Generalized bone, joint, or muscle pain
  • Nausea, bloating, vomiting, and stomach pain
  • Back pain
  • Generalized overall weakness
  • Diarrhea, gas, or constipation
  • Swelling of the feet or hands
  • Bloating

Merck & Company, the drug’s manufacturer, and physicians tell patients to stop using Fosamax and alendronate if they develop serious side effects or signs of allergic reaction such as swelling of the tongue, lips, face or throat, or difficulty in swallowing.

Bisphosphonate-Related Atrial Fibrillation

University of Wisconsin Researchers conducted a study in 2008 that uncovered how using Fosamax to treat a variety of bone weakening issues, the drug could produce twice the potential risk of developing atrial fibrillation. Afib it is a common heart issue that results in irregular heartbeats leading to fainting, dizziness, and fatigue. The study uncovered that the drug produced a more than 86 percent higher risk of developing atrial fibrillation when compared individuals who had never taken the medication.

This study came on the heels of another public study in the New England Journal of medicine (May 7, 2008 issue). The study revealed that older post-menopausal females using bisphosphonate medications, including Fosamax, have an increased potential risk of developing irregular heartbeats and were more at risk of developing heart rhythm irregularities compared to those who never took the drug.

Bisphosphonate-Related Severe Muscular Pain

In 2001, the US Food and Drug Administration warned users of bisphosphonate, including Fosamax, had an increased potential of developing severe and or incapacitating muscle, joint, and bone pain. The FDA was concerned that the correlation of severe musculoskeletal pain and the use of bisphosphonates could be overlooked by doctors who might delay the diagnosis, prolong the impairment, or avoid treating the patient’s pain.

The regulatory agency warned that bisphosphonate use leading to severe musculoskeletal pain could begin within just a few days, months or years of the beginning use of a bisphosphonate. The FDA recommended that doctors consider permanently or temporarily discontinuing use of the medication if severe musculoskeletal pain in patients occurs.

Fosamax Precautions and Contraindications

Common precautions and contraindications concerning Fosamax include:

  • Acute gastrointestinal tract inflammations including ulcerations, gastritis, and esophagitis
  • Hypocalcemia
  • Pregnancy and breast-feeding
  • Hypersensitivity or allergic reaction to alendronate
  • Esophagus achalasia (difficulty swallowing) and structures caused by malfunctions and malformations
  • Renal impairment
  • Clinically manifested osteomalacia (softening bones caused by calcium and vitamin D deficiencies)

Drug interactions caused by combining Fosamax with other medications can cause significant problems. The pharmaceutical drug company and doctors recommend avoiding combining Fosamax (alendronate) with other drugs that include:

  • Aspirin
  • Lipitor
  • Metformin
  • Lisinopril
  • Levothyroxine
  • Folic acid
  • Calcium mixed with vitamin D
  • Tylenol
  • Prilosec
  • Prednisone
  • Plavix
  • Nexium
  • Simvastatin
  • Metoprolol
  • Gabapentin
  • Synthroid
  • Omeprazole
  • Vitamin D3

Fosamax Recalls

In October 2010, the U.S. Food and Drug Administration (FDA) updated available information concerning atypical fractures caused by the use of bisphosphonate medications, including Fosamax, for the treatment of osteoporosis. The warnings described dangerous side effects including jawbone deterioration and esophagus ulcers.

Since alendronate was first introduced to the medical marketplace in 1995, the product is been heavily marketed to adults. However, there have been significant health issues including unexpected broken bones and jawbone deterioration that is occurred even if the product is discontinued or taken for a short time. Unfortunately, it was not the FDA that identified the problem. An independent research team spent years pushing the FDA until it instituted much-needed label changes to increase public awareness.

Six years earlier in 2004, the Food and Drug Administration confirmed that many by phosphonate medications, including Fosamax) had a direct link to the development of jaw -related osteonecrosis (Dead Jaw Syndrome). Many patients suffering from the condition had irreversible and complete jawbone destruction. Even though the FDA required the company to make changes to its warning labels, the drug maker waited until July 2005 to do so. In the meantime, the public relations department at the pharmaceutical company launched an expensive campaign to deny the connection of taking the drug and osteonecrosis.

By 2010, the Food and Drug Administration ordered Merck to adjust his drug label warnings to include femur fractures. Before the FDA took quick action, they obtained reports where more than nine out of every 10 of the 300 individuals in the study who were suffering from random femur breaks had been using Fosamax for five years or longer.

The following year (2011), Merck was faced with a serious problem with their bone loss treatment medication when it was discovered that taking the drug could cause esophagus irritation and potentially esophageal cancer. Since then, federal medication regulators have made claims that there might not be a direct correlation to esophageal cancer and using alendronate or Fosamax.

Fosamax Lawsuits

Fosamax drug manufacturer Merck & Company is now facing thousands of lawsuits filed by plaintiffs who suffered serious side effects. Many of these plaintiffs claim that the company failed to warn them of potentially serious side effects including toxic epidermal necrosis, esophageal cancer, worsening heartburn, and jaw deterioration. Some plaintiffs have experienced unexpected femur fractures from minimal exertion on the thigh bone.

Many injured victims were unaware of the potential risks the medication causes and begin taking legal action to pursue financial compensation against the medication company. While little can be done to improve the quality of life for many of these victims, they do have a legal opportunity to seek financial recompense through an out-of-court settlement or jury award.

  • One Million Dollars Awarded to a Florida Woman Resolves Her Fosamax Injury Lawsuit

June 2010 – A Florida woman has been awarded $8 million by a jury four years after filing a lawsuit against Merck & company. The plaintiff had claimed that the pharmaceutical giant’s Fosamax osteoporosis treatment medication has caused significant damage to her jaw. The jury award is considered a major victory by many plaintiffs who have filed more than 900 lawsuits against the Drug Maker. Many of these plaintiffs are alleging that the company is directly responsible to jawbone tissue damaged by Fosamax.

The multibillion-dollar award will likely open the door for consolidation of thousands of lawsuits to come by creating a massive class action suit against Merck. Many plaintiffs are claiming that their doctor prescribed the medication as an effective solution for treating or preventing osteoporosis by improving strength and increasing bone density. However, the plaintiffs are alleging that the drug is defective and contributed to femur fractures and jaw osteonecrosis (dying jawbone tissue).

  • Merck Facing One More Fosamax Femur Fracture Lawsuit

2010 – An Illinois couple filed a Fosamax femur fracture lawsuit against pharmaceutical giant Merck & Company alleging that the wife suffered a femur fracture after taking the medication for the treatment of osteoporosis. While some documents reveal that the plaintiff Dr. prescribed Fosamax for condition ten years earlier. She took the osteoporosis treatment medication between 2001 and 2012 when she began experiencing brittle and weakened bones. The plaintiff alleges that the drug caused a low energy femoral fracture caused by minimal impact.

This is not the first lawsuit filed against Merck & Company claiming allegations that the bone loss treatment drug caused significant problems and health complications. By 2015, more than 2500 Fosamax lawsuits have been filed in state and federal courts. A multidistrict litigation case has been established to consolidate many of these lawsuits that will be heard in the U.S. District Court for the Southern District of New York.

  • Jaw Deterioration Victim Receives Millions in a Fosamax Lawsuit Settlement

A female plaintiff reached a settlement with Merck & Company to resolve her Fosamax lawsuit. The plaintiff in the case had claimed damage to her jaw occurred because she took Fosamax. Lawsuit documents reveal that the woman was suffering from osteonecrosis of the jaw (dying jaw tissue). After an initial mistrial from the first Fosamax lawsuit, the plaintiff was awarded $1.5 million in compensatory damages in June 2012, which she refused to accept, choosing instead to hold the third trial.

The settlement was reached just before the third trial began. However, because of confidentiality agreements, the actual amount of monetary compensation given to the plaintiff remains confidential to the public.

Let Us Handle Your Fosamax Lawsuit

The reputable Fosamax injury case attorneys at the Drug Law Center can provide immediate legal assistance to ensure you and your family receive the monetary compensation you deserve. If you or a loved one suffered an injury caused by Fosamax (alendronate sodium). Our law firm has access to vast resources and years of extensive experience in successfully resolving complex product liability cases against pharmaceutical companies and medical device manufacturers.

Our lawyers are now accepting Fosamax injury cases through contingency fee agreements. This means you will never pay any out-of-pocket expenses to cover our legal services. We will receive no attorney fees unless and until we secure financial recovery for the damages that Fosamax has caused.

If you or a loved one has taken Fosamax or the generic form alendronate sodium for the treatment of Paget’s disease or osteoporosis and suffered injuries of the femur bone, shoulder, knee, hip, jaw, or another body part, contact us now to schedule a free, comprehensive consultation to protect your rights.

Sources:
http://www.health.harvard.edu/diseases-and-conditions/whats_the_story_with_fosamax
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020560s060,021575s020lbl.pdf
https://www.fda.gov/Drugs/DrugSafety/ucm101551.htm
https://www.fda.gov/downloads/drugs/drugsafety/ucm241519.pdf
https://www.merck.com/product/usa/pi_circulars/f/fosamax/fosamax_pi.pdf