Fosamax: Legal Issues and Research

Fosamax (alendronate sodium) is a drug doctors prescribe for patients with osteoporosis and Paget’s disease of bone. Paget’s disease is a medical condition in which the body replaces healthy bones with weak ones. Osteoporosis is a health condition that weakens bones. It may have natural causes, or patients may develop it from taking corticosteroids.

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 has proven effective in patients suffering from severe bone loss and loss of bone density. Still, Fosamax has been linked to serious side effects such as:

• Abdominal pain
• Esophageal irritation
• Osteonecrosis of the jaw (ONJ)

This article describes Fosamax’s uses, side effects, and risks. You’ll also find important legal and research information regarding this medication.

If you have been harmed by Fosamax or another pharmaceutical, consider contacting a product liability attorney near you. An attorney can assess if you have a valid claim, and if so, guide you through the legal process. Your lawyer will advocate for your best interests and fight for fair compensation for your injuries.

What Are Bisphosphonate Drugs?

Fosamax is a bisphosphonate drug. These medications reduce bone loss by slowing down osteoclasts, the cells responsible for breaking down old bone.

Other bisphosphonates include:

• Actonel
• Aredia
• Boniva
• Didronel
• Reclast
• Skelid
• Zometa

Talk to Your Healthcare Professional Before Taking Fosamax

Before taking Fosamax, meet with your healthcare professional to get medical advice. You must tell them if you’ve ever had an unusual allergic reaction to Fosamax or other foods, preservatives, or dyes. Let them know if you’re pregnant, plan to become pregnant, or are breast-feeding.

Also, tell your healthcare professional if you suffer from other health conditions. Some of the conditions that may impact your Fosamax intake include:

• Difficulty swallowing
• Kidney problems
• Heartburn
• Ulcers
• Low levels of calcium in your blood
• Frequent muscle cramps or spasms
• Osteomalacia (softening of bones due to a lack of vitamin D)

Tell your healthcare professional if you can’t sit or stand upright for 30 minutes or are on special diets (such as a low-sodium or low-sugar diet). You should also read your medication guide thoroughly before taking any prescription medication.

What To Know When Taking Fosamax

Take Fosamax orally with a full glass (6 to 8 ounces) of plain water on an empty stomach. Patients should take Fosamax in the morning before their first food of the day. You must also take Fosamax before any food, beverage, or other medicine (such as antacids, calcium, and vitamin supplements).

Don’t lie down for 30 minutes after taking Fosamax. Remaining upright prevents irritation to the esophagus and allows Fosamax to reach your stomach faster.

When taking Fosamax, follow your doctor’s orders or the directions on the label. If you miss a dose of Fosamax, don’t take it later in the day. Resume your usual schedule the next morning. Don’t take an extra tablet of Fosamax after a missed dose.

Side Effects of Fosamax

Most drugs carry adverse side effects. Whether you take an oral solution of Fosamax or tablets, you’ll likely experience some side effects. The most common side effect associated with Fosamax is abdominal pain.

Other less common side effects include:

• Difficulty or painful swallowing
• New or worsening heartburn
• Chest pain
• Upset stomach
• Vomiting (bloody vomit or vomit that looks like coffee grounds)
• Black, tarry, or bloody stools
• Mouth sores or pain in the mouth
• Itching
• Hives
• Swelling of eyes, face, lips, tongue, or throat
• Flu-like symptoms
• Constipation
• Digestive problems
• Fever
• Irritation or pain in the esophagus
• Muscle pain and joint pain

Skin rash is a rare side effect, but it may be severe and worsen with exposure to sunlight.

In addition to these side effects, the drug can cause other adverse reactions. One of the significant side effects of Fosamax is osteonecrosis of the jaw (ONJ). This condition causes the jaw to crumble, 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.

Fosamax Drug and Food Interactions

Fosamax and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take. This includes prescription and non-prescription medicines. It also includes things like calcium supplements, vitamins, and other substances.

Be sure to tell your healthcare professional if you take any of the following:

• Aspirin or products that contain aspirin
• Antacids
• Non-steroidal anti-inflammatory medications (NSAIDS) such as ibuprofen and naproxen
• Doxycycline (Doryx, Vibramycin)
• Quinidine (Quinaglute)
• Tetracycline (Sumycin)
• Calcium, iron, or potassium supplements

Your doctor needs this information to ensure you don’t experience an adverse drug or food interaction.

Research on Fosamax

The FDA receives reports from patients who experience adverse health consequences after taking prescription drugs. Many patients taking Fosamax reported minor and severe side effects.

One of these severe side effects is osteonecrosis of the jaw (ONJ). ONJ causes your jawbone to crumble and die, hence its nickname, “jaw death.” ONJ causes severe pain, loose teeth, exposed jawbones, loss of jaw function, and disfigurement of the face.

During clinical trials of more than 17,000 patients, there were no reports of ONJ. Cancer patients taking bisphosphonate medications may have been the primary or only reporters of ONJ. Patients suffering from ONJ after taking Fosamax sued Merck. The drugmaker settled over 12,000 lawsuits for more than $27 million.

A study in the British Medical Journal linked the use of osteoporosis bisphosphonate drugs to esophageal cancer. Researchers are still investigating the long-term effects of taking Fosamax. Generally, reports show that the benefits of Fosamax and other bisphosphonates far outweigh the potential 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.

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.

Timeline of Fosamax Legal Updates

Follow along below for significant Fosamax litigation updates.

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 had 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 reached 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.

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.

September 2024: Third Circuit Court of Appeals Overturns  Judge’s Ruling

The Third Circuit Court of Appeals overturns the judge’s ruling, saying Merck had not shown that the FDA would have rejected any and all possible warnings that state law might have required.

The court emphasized that federal law is generally not supposed to override state laws unless there’s a very clear conflict. The court also felt the judge relied too heavily on informal conversations and a letter from the FDA (an “amicus brief” or “friend of the court” brief) when making the decision.

This marked a significant victory for the plaintiffs suing Merck. This decision means their claims are no longer blocked by the federal preemption argument. Their lawsuits can move forward.

Getting Legal Help for a Fosamax-Related Injury

All medications have certain anticipated side effects. Some have serious side effects. Drug manufacturers must make their products as reasonably safe as possible. They must also inform the medical community and the public of known risks associated with its drugs.

If a manufacturer fails to do so, they may be legally responsible for patient injuries. If you suffer an injury due to inadequate warnings or the unreasonably dangerous nature of the drug, you may be able to sue the drug manufacturer under product liability.

Contact an attorney in your area to discuss your pharmaceutical liability case. FindLaw’s directory of product liability attorneys can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with dangerous drug cases.