Dangers and Side Effects of Fosamax
By Christie Nicholson, J.D. | Legally reviewed by Oni Harton, J.D. | Last reviewed February 16, 2024
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Fosamax (alendronate sodium) is a drug doctors prescribe for patients with osteoporosis and Paget's disease. The Food and Drug Administration (FDA) approved Fosamax in 1999. Merck & Co., the manufacturer of the drug, markets the medication primarily to postmenopausal women.
Fosamax is generally safe. But, like most drugs, there are potential side effects. This is true for all bisphosphonate drugs. Here, we'll discuss its adverse side effects. We will also describe recent research showing that the drug may be more dangerous than the FDA initially thought.
Common Side Effects of Fosamax
Fosamax is a popular osteoporosis drug. Merck markets the drug to American men and women suffering from bone loss and loss of bone density. It's also helpful for patients with low calcium levels.
Like most other prescription drugs, Fosamax has potential side effects. The common side effects of the osteoporosis drug Fosamax include:
- Chest pain
- Heartburn
- Ulcers
- Low calcium levels
- Difficulty swallowing
In addition to these side effects, there are other adverse reactions to the drug. One of the significant side effects of Fosamax is osteonecrosis of the jaw (ONJ). This is a condition where your jaw crumbles, causing intense pain and severe tooth loss.
Before prescribing the drug, healthcare providers must explain the potential side effects to patients. If your doctor doesn't explain the possible side effects and you become sick after taking Fosamax, you may have a claim for medical malpractice.
2013: Merck Settles Fosamax ONJ Lawsuits
By 2013, more than 1,200 patients had sued Merck, claiming that Fosamax caused ONJ. The plaintiffs alleged that the drugmaker knew Fosamax caused osteonecrosis of the jaw and chose not to warn patients about it.
In 2013, Merck settled the lawsuits for more than $27 million.
March 2022: District Court Judge Dismisses Fosamax Fracture Lawsuits
Starting in 2008, hundreds of Fosamax patients sued Merck over atypical fractures they suffered while taking the drug. Plaintiffs argued that Merck was aware that its osteoporosis drug could cause thigh bone fractures. Merck chose not to warn patients.
The lawsuits also alleged that Fosamax caused atypical femur fractures. The plaintiffs claimed they suffered atypical femoral fractures and thigh bone fractures. The courts consolidated the 500 lawsuits into a multidistrict litigation (MDL) matter.
Merck submitted evidence that it asked the FDA if Merck could add a warning about fractures to their drug labels. The FDA sent a letter to Merck in 2009 rejecting the change in Fosamax labeling.
The Fosamax lawsuits made it before the U.S. Supreme Court. The judges said federal law preempted the plaintiffs' state law claims because the FDA governed drug companies' warning labels. Preemption meant the lawsuits would return to state courts.
According to Reuters, the U.S. Court of Appeals for the Third Circuit affirmed the Supreme Court's ruling. In March 2022, the lower court judge dismissed all 500 product liability lawsuits. This was the second time Merck convinced the courts to dismiss Fosamax cases involving fracture risks.
Can You Sue if You're Hurt After Using Fosamax?
If you suffered bone fractures or ONJ after taking Fosamax, you have options. Depending on the facts of your case, you may have a valid product liability claim against Merck. Whether you recover damages will depend on the nature and severity of your injuries.
In any product liability case, you must prove that the defendant knew their product was dangerous and chose not to warn consumers. In a dangerous drug case, you must prove that the pharmaceutical company knew its drug posed health risks. You must also show that the drug company did not warn patients about these risks.
You may be able to sue if you took Fosamax and suffered from any of the following:
- Atypical fractures
- Hip fractures
- ONJ
Your product liability lawyer must prove that using Fosamax caused your injuries. They must also show that Merck failed to warn the public about your injury.
Don't Miss the Statute of Limitations
If you decide to sue a drug manufacturer, you must do so before the statute of limitations expires. Every state has laws dictating how long plaintiffs must file their claims. If you miss this deadline, the courts will dismiss your lawsuit.
Contact an experienced product liability attorney as soon as possible after your injury.
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