Zometa is an intravenous bisphosphonate drug used to treat hypercalcemia or excess calcium in the blood. Hypercalcemia occurs with some types of cancer. Zometa also treats multiple myeloma (bone marrow tumors) and bone metastasis (the spread of cancer in the bones). The generic name of this medication is zoledronic acid.
Zometa and Osteonecrosis of the Jaw
Osteonecrosis of the Jaw (ONJ) or "jaw death" is a medical condition where the jawbone partially crumbles and dies. ONJ 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 to describe ONJ, was observed in some cancer patients receiving intravenous bisphosphonates, such as Zometa and Aredia. The revised information recommends patients with cancer receive a dental exam before starting bisphosphonate medications and avoid invasive dental procedures while on these drugs.
Other FDA Safety Advisories and Changes for Zometa
In April 2014, the safety warnings for Zometa were changed to include hypocalcemia or low amounts of calcium in the blood, which was reported in patients treated with the drug. Severe cases of hypocalcemia may be life threatening and some patients also experienced abnormal heart rhythms and seizures or 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 be within days to years from taking bisphosphonates and risk factors are unknown. Drugs included in this alert were: Actonel, Aredia, Boniva, Didronel, Fosamax, Reclast, Skelid, and Zometa.
As an intravenously administered drug, Zometa should only be taken under the supervision of your healthcare professional. Follow your doctor's orders regarding Zometa dosing. It's important that your healthcare professional check your progress during regular visits after you start taking Zometa, even if your condition improves. Tell your doctor right away if you experience any of the following symptoms while taking Zometa:
- Blood in your urine
- Decreased urine output
- Muscle twitching
- Rapid weight gain
- Swelling of face, ankles, or hands
- Unusual tiredness or weakness
These could be signs of serious kidney problems.
Zometa Health Risks and Side Effects
Zometa may cause side effects, both common and less serious conditions and severe side effects that you should immediately tell your doctor about. If you experience any of these symptoms severely or persistently, tell your doctor:
- Redness or swelling in the place where you received your injection
- Red, swollen, or teary eyes
- Constipation or diarrhea
- Upset stomach or stomach pain
- Loss of appetite or weight loss
- Difficulty swallowing
- Mouth sores
- Pain anywhere in the body
- Excessive worry
- Difficulty falling asleep or staying asleep
- White patches in the mouth
- Swelling, redness, irritation, burning, or itching of the vagina
- White vaginal discharge
- Hair loss
The following Zometa side effects are uncommon, but serious, be sure to call your doctor immediately if you experience any of them:
- Fever, chills, and other signs of infection
- Bone, joint, or muscle pain, and other flu-like symptoms
- Chest pain
- Sudden tightening of muscles
- Muscle cramps or weakness
- Leg swelling
- Difficulty walking
- 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
- Sunken eyes
- Pale skin
- Unusual bruising or bleeding
- Excessive thirst
- Seeing things or hearing voices that don't exist
- Double vision
- Difficulty speaking
- Jaw or mouth pain
Getting Legal Help
While all medications have certain, anticipated side effects, a prescription drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform healthcare professionals and the public of known risks associated with its medications. If a manufacturer fails to do so, it can be held legally responsible for any injuries caused by inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."
If you or a loved one has experienced any dangerous symptoms or unusual medical conditions while taking Zometa, you should contact your doctor. You may then want to meet with an experienced attorney to discuss your legal options and to protect your right to a legal remedy for any injuries caused by Zometa.
To learn more about an attorney's role in a pharmaceutical liability case, see the Get Legal Help with a Defective Product Injury article.
Contact a qualified product liability attorney to make sure your rights are protected.