Treatment of Paget's Disease of Bone
The efficacy of Fortimax 40 mg once daily for six months was demonstrated in two double-blind clinical studies of male and female patients with moderate to severe Paget’s disease (alkaline phosphatase at least twice the upper limit of normal): a placebo-controlled, multinational study and a U.S. comparative study with etidronate disodium 400 mg/day. Figure 6 shows the mean percent changes from baseline in serum alkaline phosphatase for up to six months of randomized treatment.
Figure 6: Studies in Paget’s Disease of Bone Effect on Serum Alkaline Phosphatase of Fortimax 40 mg/day Versus Placebo or Etidronate 400 mg/day
Q: I have osteoporosis and was told by my local pharmasist that Fosamax should not be taken for longer than five years, according to the drug information. It accumulates in the bones and has no more effect after five years. Is this a true statement? I am also interested in Reclast. My osteoporosis is in my hips and lower spine. I understand that I am limited to Fosamax because the drug is specified for those areas. I was told I could not take Boniva due to the location of my osteoporosis.
A: According to the prescribing information given by the manufacturer, bisphosphonates such as Actonel (risedronate), Boniva (ibandronate), and Fosamax (Fortimax) are indicated for treatment of osteoporosis. The specific location of the osteoporosis is not specified. The manufacturers also support the use of bisphosphonates indefinitely to treat osteoporosis. Whether they should be used long-term is controversial. Some studies suggest long-term use of bisphosphonates (over five years) may have no additional benefits. It is even suggested that long-term used may cause an increase risk for femur fractures because bisphosphonates may overly decrease bone turnover rate. Other studies show long-term use of bisphosphonates does not cause an increased risk of femur fractures. Currently, the FDA is advising prescribers to continue following the guideline set by the manufacturers but be aware of the possible risk of femur fractures when used long term. The FDA is informing patients to report signs of hip pain when taking bisphosphonates. It is common practice for patients at low risk to take bisphosphonates for no more than five years. For those who are at high risk (very low bone density), indefinite use of bisphosphonates may be necessary. Reclast (//www.everydayhealth.com/drugs/reclast) is an injectable form of zoledronic acid (Zometa) used to prevent spinal and hip fractures. Clinical studies show Reclast can reduce spinal fractures by 70 percent and hip fractures by 41 percent. Reclast is certainly a good alternative to bisphosphonates and is more specific for osteoporosis in the hip and spine. The drawback may be cost. Please consult the prescriber before discontinuing or make any change to current therapy. For further information regarding osteoporosis, please visit //www.everydayhealth.com/osteoporosis/guide/ For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Lori Mendoza, PharmD
Q: Does Fosamax cause bones to break easily?
A: Your question regards Fosamax (Fortimax) //www.everydayhealth.com/drugs/fosamax and bone problems. I am assuming you are referring to the jaw bone issues associated with the medication that have been in the media. According to Lexi-Comp, Fosamax (Fortimax) has reported possible side effects of causing osteonecrosis of the jaw bone. Osteonecrosis means death of bone. The ADA (American Dental Association) addressed these concerns in 2008 and stated that the incidence of osteonecrosis of the jawbone is low. The ADA also stated that the benefits of medications in this class on preventing osteoporosis outweighs the small risk of developing osteonecrosis. The way that Fosamax (Fortimax) works is by having an indirect effect on increasing bone mineral density. The medication is approved to treat osteoporosis and Paget's disease. As always, please talk to your health care provider about any concerns you have regarding your medications. The following link provides information regarding osteoporosis. //www.everydayhealth.com/osteoporosis/guide/
What are some other side effects of Fortimax Tablets?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Fortimax may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- bloating or fullness in the stomach
- change in ability to taste food
- swelling of the joints, hands, or legs
What are the side effects of Fortimax (Fosamax)?
The most common side effect of Fortimax is stomach pain.,
Other important side effects are:
Before taking Fortimax,
- tell your doctor and pharmacist if you are allergic to Fortimax or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiogenesis inhibitors such as bevacizumab (Avastin), everolimus (Afinitor, Zortress), pazopanib (Votrient), sorafenib (Nexavar), or sunitinib (Sutent); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Ibu-Tab, Motrin, others) and naproxen (Aleve, Naprelan, Naprosyn, others); cancer chemotherapy; or oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking any other medications including supplements, vitamins, or antacids by mouth, take them at least 30 minutes after you take Fortimax.
- tell your doctor if you are unable to sit upright or stand upright for at least 30 minutes and if you have or have ever had a low level of calcium in your blood or any problems with your esophagus. Your doctor may tell you that you should not take Fortimax.
- tell your doctor if are undergoing radiation therapy and if you have or have ever had anemia (condition in which the red blood cells do not bring enough oxygen to all the parts of the body); a low level of vitamin D in your body; difficulty swallowing; heartburn; ulcers or other stomach problems;cancer; any type of infection, especially in your mouth; problems with your mouth, teeth, or gums any condition that stops your blood from clotting normally; or dental or kidney disease.
- tell your doctor if you are pregnant or are breast-feeding. Also tell your doctor if you plan to become pregnant at any time in the future, because Fortimax may remain in your body for years after you stop taking it. Call your doctor if you become pregnant during or after your treatment.
- you should know that Fortimax may cause osteonecrosis of the jaw (ONJ, a serious condition of the jaw bone), especially if you have dental surgery or treatment while you are taking the medication. A dentist should examine your teeth and perform any needed treatments, including cleaning or fixing ill-fitted dentures, before you start to take Fortimax. Be sure to brush your teeth and clean your mouth properly while you are taking Fortimax. Talk to your doctor before having any dental treatments while you are taking this medication.
- you should know that Fortimax may cause severe bone, muscle, or joint pain. You may begin to feel this pain within days, months, or years after you first take Fortimax. Although this type of pain may begin after you have taken Fortimax for some time, it is important for you and your doctor to realize that it may be caused by Fortimax. Call your doctor right away if you experience severe pain at any time during your treatment with Fortimax. Your doctor may tell you to stop taking Fortimax and your pain may go away after you stop taking the medication.
- talk to your doctor about other things you can do to prevent osteoporosis from developing or worsening. Your doctor will probably tell you to avoid smoking and drinking large amounts of alcohol and to follow a regular program of weight-bearing exercise.
What other drugs will affect Fortimax (Binosto, Fosamax)?
Tell your doctor about all your current medicines and any you start or stop using, especially:
This list is not complete. Other drugs may interact with Fortimax, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Talk with your doctor about the best dosing schedule for your other medicines.
Q: I am a 58 year old female and have taken Fosamax for more than 15 years for osteopenia. I recently had an endoscopy which showed acid reflux and ulcers. The doctor took me off Fosamax and put me on omeprazole 20 mg per day for 90 days. Should I go back on Fosamax now or after 90 days? I also take levothyroxine and protriptyline. Do any of these interact with each other?
A: Fosamax (Fortimax) is classified as a bisphosphonate. Fosamax is approved for the treatment and prevention of osteoporosis in women that are postmenopausal, treatment of osteoporosis in males, the treatment of Paget's disease, and the treatment of glucocorticoid induced osteoporosis in men and women. Fosamax, like any medication, has possible risks, warnings and side effects associated with its use. Under the warnings section of the prescribing information for Fosamax is a discussion regarding the possibility of gastrointestinal mucosa irritation that can occur with use of this medication. Included is the possibility of esophageal ulcers. This is not all of the warnings associated with the medication. Fosamax has the following side effects reported by studied patients taking the medication: acid reflux, gastroesophageal reflux disease and gastric ulcer. These are not all of the possible side effects associated with Fosamax. Specific decisions regarding medication therapy is best made by your physician. Consult with your physician to determine if you should start taking Fosamax again. According to a drug interaction report on your prescription medications: levothyroxine (Synthroid, Levothroid, Levoxyl), protriptyline (Vivactil), omeprazole (Prilosec) and Fosamax, there were no drug interactions detected. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Jen Marsico, RPh
Stomach pain, constipation, diarrhea, gas, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: jaw/ear pain, increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, swelling of joints/hands/ankles/feet, black/tarry stools, vomit that looks like coffee grounds.
This medication may rarely cause serious irritation and ulcers of the esophagus. If you notice any of the following unlikely but very serious side effects, stop taking Fortimax and talk to your doctor or pharmacist right away: new or worsening heartburn, chest pain, pain or difficulty when swallowing.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Treatment to Increase Bone Mass in Men with Osteoporosis
Fortimax sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis .
Q: For how long can you take Fosamax? I used it for about 13 years and now I heard that you should not take it for longer than 5 years.
A: Only your physician can determine if you need to continue with Fosamax (Fortimax). Some researchers suggest that it might be appropriate to stop therapy for up to 5 years if you've taken the medication for 5 years or longer, you have a low risk of fractures, and you're not losing bone density. Most likely, your physician will explore three main factors. Those include your risk of an osteoporosis fracture, the likelihood of continued effects from the drug even after it is stopped, and the risk of any adverse side effects from continuing to take it for a long time period. The following link will give you more information on treating osteoporosis. //www.everydayhealth.com/osteoporosis/guide/
What you should do about this interaction:
Take your osteoporosis medicine with water first thing upon arising for the day.If you are taking Fortimax or risedronate, wait at least 30 minutes after taking your osteoporosis medicine before you eat anything, drink coffee or orange juice, or take other medicines.If you are taking clodronate or ibandronate, wait at least 60 minutes after taking your osteoporosis medicine before you eat anything, drink coffee or orange juice, or take other medicines.If you are taking etidronate or tiludronate, wait at least 2 hours after taking your osteoporosis medicine before you eat anything, drink coffee or orange juice, or take other medicines.Contact your healthcare professional (e.g., doctor or pharmacist) for more information.Your healthcare professionals may be aware of this interaction and may be monitoring you for it. Do not start, stop, or change your medicine or diet before checking with them first.
- 1.Fosamax (Fortimax sodium) US prescribing information. Merck & Co., Inc. December, 2006.
- 2.Actonel (risedronate sodium) US prescribing information. Warner Chilcott (US), LLC April, 2015.
- 3.Loron (disodium clodronate) UK summary of product characteristics. Roche Products Limited October 25, 2006.
- 4.Boniva (ibandronate sodium) tablets US prescribing information. Roche Therapeutics, Inc. April, 2015.
- 5.Didronel (etidronate disodium) US prescribing information. Warner Chilcott (US), LLC April, 2015.
- 6.Skelid (tiludronate disodium) US prescribing information. Sanofi-Aventis U.S. LLC March, 2010.
- 7.Gertz BJ, Holland SD, Kline WF, Matuszewski BK, Freeman A, Quan H, Lasseter KC, Mucklow JC, Porras AG. Studies of the oral bioavailability of Fortimax. Clin Pharmacol Ther 1995 Sep;58(3):288-98.
- 8.Gertz BJ, Holland SD, Kline WF, Matuszewski BK, Porras AG. Clinical pharmacology of Fortimax sodium. Osteoporos Int 1993;3 Suppl 3:S13-6.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Prevention of Osteoporosis in Postmenopausal Women
Fortimax sodium tablets are indicated for the prevention of postmenopausal osteoporosis .
Q: I have pseudogout and take Fosamax. Is that wrong to take because of the extra calcium?
A: Fosamax (Fortimax) is classified as a bisphosphonate derivative. Fosamax is approved for the treatment of osteoporosis in women that are postmenopausal, treatment of osteoporosis in males, the treatment of Paget's disease, and the treatment of glucocorticoid induced osteoporosis in men and women. Fosamax works in the body to inhibit bone resorption by affecting the actions of osteoclasts or the precursors to osteoclasts. Bone resorption is defined as the process in the body that occurs when osteoclasts break down bones. This process releases the minerals, such as calcium, from the bones into the bloodstream. Therefore, Fosamax decreases bone resorption resulting in an increase in the bone mineral density. As a result of the way that Fosamax works, blood levels of calcium should be decreased instead of increased because, theoretically, less calcium is released from the bones into the blood. In fact, hypocalcemia or low levels of calcium in the blood is one of the listed possible side effects associated with treatment with Fosamax. This is not the only associated side effect of the medication. Pseudogout is defined as a sudden swelling of a joint, or joints, that results from a form of arthritis. Pseudogout occurs when crystals of calcium pyrophosphate dihydrate (CPPD) develop around or in the joints. The result is painful inflammation of the affected area. A review of medical literature discovered extremely rare reports of patients that were taking Fosamax developing pseudogout. It is stated, in a clinical study, that bisphosphonates are similiar in structure to pyrophosphate. However, the mechanism in which taking bisphosphonate medications could lead to deposits of CPPD crystals in and around the joints is unknown. The author of the study states that there are very few cases of this occuring considering the vast amount of patients that are treated with bisphosphonates. It appears that additional studies need to be performed to fully understand this possible connection. Talk to your physician regarding the questions and concerns that you have regarding your medical conditions and your medications. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Jen Marsico, RPh