Zometa (zoledronic acid) is an intravenous bisphosphonate drug that treats hypercalcemia. This is a condition where you have excess calcium in your blood. Hypercalcemia occurs with some types of cancer. Oncologists also prescribe Zometa to treat multiple myeloma (bone marrow tumors) and bone metastasis (the spread of cancer in the bones).
The FDA first approved Zometa in 2001 for the treatment of hypercalcemia. The following year, Novartis Pharmaceuticals submitted the drug to the FDA for approval to treat cancer patients.
Over the years, the drugmaker and the FDA have warned about Zometa's risks and potential dangers.
Here, we'll provide an overview of Zometa's uses and side effects. We'll also highlight some of the news regarding this drug. Finally, we'll discuss what you should do if you believe Zometa has harmed you or your loved one.
Possible Side Effects of Zometa
Like other drugs, Zometa does have possible side effects. Some are minor, while others are more severe. If you experience serious side effects, seek immediate medical attention.
Some of the more common side effects of Zometa include:
- Constipation or diarrhea
- Upset stomach or stomach pain
- Loss of appetite or weight loss
- Difficulty swallowing
- Mouth sores
- Body and muscle pain
- Hair loss
The following Zometa side effects are severe but uncommon:
- Fever, chills, and other signs of infection
- Bone, joint, or muscle pain and other flu-like symptoms
- Rash or hives
- Chest pain
- Sudden tightening of muscles
- Muscle cramps or weakness
- Leg swelling
- Fast, pounding, or irregular heartbeat
- Shortness of breath
- Numbness, burning, or tingling in fingers or toes
- Dry mouth
- Frequent urination, especially at night, or increased urination
- Unusual bruising or bleeding
- Seeing things or hearing voices that don't exist
- Double vision
- Difficulty speaking
- Jaw or mouth pain
Of course, you aren't likely to experience these side effects after a single dose of Zometa. But if they persist, talk to your doctor immediately. Some of these side effects are signs of kidney problems. Not seeking treatment could cause long-term and life-threatening damage.
What To Tell Your Healthcare Professional Before Taking Zometa
Tell your healthcare professional if you're allergic to Zometa or other medications for high blood calcium or osteoporosis. You must also tell your doctor if you're pregnant, trying to become pregnant, or breastfeeding.
Before taking Zometa, inform your prescribing physician if you suffer any of the following:
- Allergies to other substances (foods, preservatives, or dyes)
- Heart disease
- Kidney disease
- Cancer or are undergoing cancer treatment
- Planning dental procedures or surgery
- Poor dental hygiene
- Liver problems
Your doctor will ensure that it's safe for you to take Zometa before prescribing it.
Who Would Benefit From Taking Zometa?
Healthcare providers typically prescribe Zometa to patients suffering from the conditions described above. People who suffer from hypercalcemia may benefit from taking this drug. Zometa may be an option if you have this condition and have tried vitamin D supplements to help control your calcium production.
Zometa is also helpful for patients with severe bone loss, including thigh bone pain. This drug is also beneficial for people with prostate cancer.
Patients with multiple myeloma may also consider taking Zometa. This is especially true for older adults who have a hard time taking drugs orally. It's also a good option for patients with difficulty managing their prescription medications.
Certain People Should Avoid Zometa
As with other drugs, certain patients should not take Zometa. According to the FDA and Norvartis' labeling, Zometa can be harmful to patients with kidney problems. The drugmaker doesn't recommend Zometa for pediatric patients or pregnant women.
According to the FDA, people with the following conditions should avoid taking Zometa:
- Asthma: These patients may experience trouble breathing while taking this medication.
- Issues with kidney function: Patients with hepatic impairment should not take Zometa.
- Pregnancy: Women who are pregnant or breastfeeding must avoid Zometa.
Pediatric patients and older adults should also avoid taking this medication. Studies show that Zometa and other bisphosphonates may harm embryos and fetuses. If you take this drug while pregnant, your baby may suffer severe developmental disorders.
Zometa and Pregnant Women With Breast Cancer
In 2007, Novartis applied to the FDA to approve Zometa for pregnant women with early-stage breast cancer. But on November 11, 2007, the drug company withdrew its application.
Clinical trials on treating pregnant women with breast cancer were inconclusive. The drugmaker found that the drug's benefits for this class of patients did not outweigh the potential risks.
Zometa and Adverse Drug Interactions
Zometa negatively interacts with certain medications. This is why you must tell your healthcare professional about your medications. This includes prescription and non-prescription drugs.
Some of the more common drug interactions to look out for include:
- Loop diuretics
- Nephrotoxic drugs
You can ask your doctor if there are any foods to avoid while taking Zometa. Your healthcare provider will also explain what drugs to avoid while taking this medication.
Zometa and Osteonecrosis of the Jaw
The most severe side effect of Zometa is osteonecrosis of the jaw (ONJ), or "jaw death." ONJ is a medical condition where the jawbone partially crumbles and dies. It can cause severe pain, loose teeth, exposed jawbones, loss of function, and facial disfigurement.
In September 2004, the FDA and Novartis notified doctors and dentists of changes to the Zometa prescribing information. The revised information included the ONJ risk. This was after a study in JAMA Oncology found that patients who took Zometa were at an increased risk of developing ONJ.
The National Cancer Institute funded this study. Researchers saw that patients who had taken Zometa for one year had a 1% chance of developing this condition. Patients taking the drug for two years had a 2% risk. The study also found that the chance of getting ONJ increased in patients who took the drug more frequently.
The revised pamphlet for Zometa recommended that patients with cancer receive a dental exam before starting bisphosphonate medications and avoid invasive dental procedures. These patients should also have dental check-ups while taking this drug. Some Zometa patients required dental surgery after just a year.
FDA Safety Advisories and Changes for Zometa
In April 2014, Novartis changed the safety warnings for Zometa to include hypocalcemia or low levels of calcium in the blood. Severe cases of hypocalcemia may be life-threatening. Some patients experienced abnormal heart rhythms, seizures, and numbness.
In January 2008, the FDA informed doctors and the public of possible severe or incapacitating bone, joint, and muscle pain in patients taking bisphosphonates. The onset of pain may occur within days to years after first taking bisphosphonates.
The other drugs included in this FDA alert include:
If you take any of these medications, avoid taking Zometa. Your doctor can find an alternate treatment option.
What To Do if You Suffer an Injury After Taking Zometa
If you or a loved one experiences dangerous symptoms or unusual medical conditions while taking Zometa, seek immediate medical attention. You may also wish to meet with an experienced product liability attorney to discuss your options. They can also help protect your legal rights.
Getting Legal Help
Most medications have side effects. Drug manufacturers must make their products as reasonably safe as possible. They must also inform healthcare professionals and the public of the known risks of its drugs. If they don't, they may be liable for patient injuries.
The only way to know if you have a valid damages claim is to meet with an experienced personal injury attorney. Visit FindLaw.com's attorney directory to find a lawyer near you.
You Don’t Have To Solve This on Your Own – Get a Lawyer’s Help
Meeting with a lawyer can help you understand your options and how to best protect your rights. Visit our attorney directory to find a lawyer near you who can help.
Contact a qualified product liability attorney to make sure your rights are protected.