Fosamax Safety, Side Effects and FDA Warnings

Fosamax is the brand name for alendronate sodium, a prescription medication primarily used to prevent and treat osteoporosis — a condition that causes bones to become weak and brittle — in men and postmenopausal women. It’s also used to treat Paget’s disease of bone, a disorder that results in weak, soft bones.

The drug was first approved in 1995, and it belongs to a drug class called bisphosphonates. Fosamax works by altering the process of bone breakdown to help slow bone loss, increase bone density and prevent bone fractures.

Organon is the drug’s current manufacturer, and before that, Merck manufactured it.

The most common side effects of Fosamax are gastrointestinal issues, such as nausea, diarrhea, constipation and cramping, according to Merck, the drug’s manufacturer. Studies show that side effects of Fosamax range from mild to severe.

People who are more susceptible to side effects from alendronate are the elderly, especially women who are more prone to developing osteoporosis.

Adverse reactions, such as bone, muscle or joint pain, affect about 4% of people who take Fosamax according to clinical trial data, but even those are rarely severe. The onset of side effects can sometimes occur after commencing treatment. Your doctor may advise you on how to prevent or mitigate some side effects.

Many side effects go away during treatment as your body adjusts to the medication. And most stop immediately after discontinuing the medication. Some people can experience lingering effects for a day or so longer, but those also go away without the drug in their system.

Serious Fosamax Side Effects

The U.S Food and Drug Administration documented several of Fosamax’s serious side effects and subsequently distributed numerous warnings to highlight the potential dangers of Fosamax. Severe side effects include bloody stools, chest pain, difficulty swallowing, skin blisters, eye pain and swelling of the face, throat and tongue.

The drug’s medication insert warns it can lower blood calcium levels because the drug hinders the natural breakdown of bone. Long-term studies showed that calcium in the blood decreased about 2% in the first month of using Fosamax and suggested adding calcium and vitamin D as supplements.

The FDA found that Fosamax patients can also develop intense bone, muscle and joint pains within days, months or years after starting the drug. For some people, this pain stops almost immediately after discontinuing the medication. For others, the side effects persist.

Peer-reviewed research has also shown a connection between the long-term use of Fosamax and femur fractures. Some people reported unexplained aching in their thigh bones for weeks and months before experiencing unexplained breaks.

Additionally, the common use of bisphosphonates, including Fosamax, caused more awareness of the medication’s link to osteonecrosis of the jaw (ONJ), a condition where gums don’t cover parts of the jawbone — mostly the mandible. Extensive dental surgeries like tooth extractions and teeth implants, oral infections, and conditions such as cancer, diabetes and kidney failure heighten the chances of jawbone death.

Femur fractures and ONJ have led people to file Fosamax lawsuits against Merck.

One Woman’s Experience with Fosamax

One patient, identified by her initials C.H. to protect her privacy, told Drugwatch that she suffered ONJ and a thigh bone fracture after taking Fosamax. She has had multiple surgeries and filed a Fosamax lawsuit.

“I didn’t understand until I looked into it more and had a professional explain it to me … Fosamax was supposed to make my bones stronger. In fact, what it does is make them brittle,” she said.

The FDA required Fosamax label changes to warn of ONJ and femur fractures.

Merck first added a warning about ONJ to Fosamax’s label in 2005. The company did so after the FDA cited increasing reports of ONJ in 2004 and urged the drugmaker to make label changes. In 2010, the FDA required Merck to add warnings about thigh fractures (atypical femur fractures) to the Warnings and Precautions section of Fosamax’s drug label.

Fosamax has been on the market since 1995. Because the ONJ and thigh fracture warnings were not added until 2005 and 2010, respectively, patients and doctors were unaware of these risks for many years.

Fosamax doesn’t have any black box warning for serious side effects that may cause serious harm or death.

In general, Fosamax is still considered safe with a small risk of ONJ and femur fractures. Fosamax is still available in the U.S. in its brand name and generic forms.

The FDA hasn’t released any information on the ideal duration of Fosamax treatment. At the time of the agency’s 2010 safety communication, evidence showed bisphosphonates were effective at reducing fractures for at least three years, and in some cases, for five years.

A study in JAMA found that the benefits of women taking bisphosphonates tapered off by year seven. Study authors said scientists need to do more research on discontinuation times. This could mean that patients may avoid the potential risk of femur fracture or ONJ by stopping the drug after the benefits taper off.

Another review from Stat Pearls suggested giving patients a break from Fosamax treatment. Patients with a low fracture risk could take this break, known as a “drug holiday,” for three to five years. Though for some, the benefits of continued therapy outweigh the risk of side effects. The review authors suggest patients should have follow-up assessments to measure their bone density and calcium levels at six to 12 months after starting treatment.

Make sure you discuss monitoring your condition with your medical provider.

Has Fosamax Been Recalled?

Fosamax has not been recalled in the U.S. The FDA said it would monitor any data regarding femur fracture risk in 2010, but there haven’t been any follow-up reports.

If you are experiencing side effects, make sure you talk to your medical provider. If you have new thigh or groin pain, it could be a sign of a femur fracture, and you should tell your medical provider right away. Your medical provider may recommend tests, such as X-rays, to rule out a femur fracture.

ONJ symptoms can last for 8 weeks or longer and include pain and swelling in the mouth, as well as part of the jawbone showing through the gums. Your dentist should monitor these symptoms.

You and your doctor can report any side effects to the FDA through its MedWatch Program.