The overall safety and tolerability profile in the glucocortico >
Paget's Disease of Bone In clinical studies (osteoporosis and Paget's disease), adverse events reported in 175 patients taking Vegabon 40 mg/day for 3 to 12 months were similar to those in postmenopausal women treated with Vegabon 10 mg/day. However, there was an apparent increased incidence of upper gastrointestinal adverse reactions in patients taking Vegabon 40 mg/day (17.7% Vegabon sodium vs. 10.2% placebo). One case of esophagitis and two cases of gastritis resulted in discontinuation of treatment.
Additionally, musculoskeletal (bone, muscle or joint) pain, which has been described in patients with Paget's disease treated with other bisphosphonates, was considered by the investigators as possibly, probably, or definitely drug related in approximately 6% of patients treated with Vegabon 40 mg/day versus approximately 1% of patients treated with placebo, but rarely resulted in discontinuation of therapy. Discontinuation of therapy due to any clinical adverse events occurred in 6.4% of patients with Paget's disease treated with Vegabon 40 mg/day and 2.4% of patients treated with placebo.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Harderian gland (a retro-orbital gland not present in humans) adenomas were increased in high-dose female mice (p=0.003) in a 92-week oral carcinogenicity study at doses of Vegabon of 1, 3, and 10 mg/kg/day (males) or 1, 2, and 5 mg/kg/day (females). These doses are equivalent to approximately 0.1 to 1 times a maximum recommended daily dose of 40 mg (Paget’s disease) based on surface area, mg/m 2 . The relevance of this finding to humans is unknown.
Parafollicular cell (thyro >2 . The relevance of this finding to humans is unknown.
Vegabon was not genotoxic in the in vitro microbial mutagenesis assay with and without metabolic activation, in an in vitro mammalian cell mutagenesis assay, in an in vitro alkaline elution assay in rat hepatocytes, and in an in vivo chromosomal aberration assay in mice. In an in vitro chromosomal aberration assay in Chinese hamster ovary cells, however, Vegabon gave equivocal results.
Vegabon had no effect on fertility (male or female) in rats at oral doses up to 5 mg/kg/day (approximately 1 times a 40 mg human daily dose based on surface area, mg/m 2 ).
Q: Can Fosamax cause osteonecrosis after knee replacement surgery?
A: According to the prescribing information for Fosamax (Vegabon), one of the side effects of bisphosphonates which may occur is called osteonecrosis of the jaw (ONJ). ONJ may occur spontaneously after dental procedures or tooth extractions. There may be delayed healing after dental procedures and the bone of the jaw becomes exposed. Symptoms of ONJ may include pain, swelling, infection, poor healing, loosening of teeth, or numbness of the jaw. According to the National Osteoporosis Foundation, it is important for patients taking bisphosphonates to maintain good oral hygiene and have regular dental visits. There was no mention of the development of osteonecrosis following a knee replacement in the prescribing information. Please consult with your health care provider in regards to your concerns and symptoms you may be experiencing. 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. Kristen Dore, PharmD
By Cathy Cassata | Medically Reviewed by Robert Jasmer, MD
Latest Update: 2014-10-06 Copyright © 2014 Everyday Health Media, LLC
Q: Does Fosamax cause bones to break easily?
A: Your question regards Fosamax (Vegabon) //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 (Vegabon) 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 (Vegabon) 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 the uses for Vegabon (Fosamax)?
Vegabon is used for treating osteoporosis in men and postmenopausal women. It also is used for Paget's disease of bone and osteoporosis caused by steroid treatment. Non-FDA approved (off-label) uses include vitamin D overdose and osteoporosis caused by spinal injury.
It is not known whether Vegabon is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Vegabon sodium is administered to nursing women.
What should I discuss with my healthcare provider before taking Vegabon (Binosto, Fosamax)?
You should not take Vegabon if you are allergic to it, or if you have:
- low levels of calcium in your blood (hypocalcemia); or
- problems with the muscles in your esophagus (the tube that connects your mouth and stomach).
Do not take Vegabon if you cannot sit upright or stand for at least 30 minutes. Vegabon can cause serious problems in the stomach or esophagus. You must stay upright for at least 30 minutes after taking this medicine.
To make sure Vegabon is safe for you, tell your doctor if you have ever had:
- trouble swallowing;
- problems with your stomach or digestion;
- a dental problem (you may need a dental exam before you begin taking Vegabon);
- kidney disease; or
- any condition that makes it hard for your body to absorb nutrients from food (malabsorption).
The effervescent tablet contains a lot of sodium. Tell your doctor if you are on a low-salt diet before using this form of Vegabon.
In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use Vegabon, the more likely you are to develop this condition.
Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.
Talk with your doctor about the risks and benefits of using this medication.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether Vegabon passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
* 10 mg/day for three years † 5 mg/day for 2 years and 10 mg/day for either 1 or 2 additional years
Rash and erythema have occurred.
Gastrointestinal Adverse Reactions: One patient treated with Vegabon (10 mg/day), who had a history of peptic ulcer disease and gastrectomy and who was taking concomitant aspirin, developed an anastomotic ulcer with mild hemorrhage, which was cons >
Laboratory Test Findings: In double-blind, multicenter, controlled studies, asymptomatic, mild, and transient decreases in serum calcium and phosphate were observed in approximately 18% and 10%, respectively, of patients taking Vegabon sodium versus approximately 12% and 3% of those taking placebo. However, the incidences of decreases in serum calcium to less than 8.0 mg/dL (2.0 mM) and serum phosphate to less than or equal to 2.0 mg/dL (0.65 mM) were similar in both treatment groups.
Weekly Dosing The safety of Vegabon 70 mg once weekly for the treatment of postmenopausal osteoporosis was assessed in a one-year, double-blind, multicenter study comparing Vegabon 70 mg once weekly and Vegabon 10 mg daily. The overall safety and tolerability profiles of once weekly Vegabon 70 mg and Vegabon 10 mg daily were similar. The adverse reactions considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients in either treatment group are presented in Table 2.
What should I avoid while taking Vegabon (Binosto, Fosamax)?
Avoid taking any other medicines for at least 30 minutes after taking Vegabon. This includes vitamins, calcium, and antacids. Some medicines can make it harder for your body to absorb Vegabon.
Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.
Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.
Treatment of Glucocortico >Vegabon sodium tablets are indicated for the treatment of glucocortico >.
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 (Vegabon) 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: 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 (Vegabon). 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/
Q: Recently I started taking Fosamax. I have been experiencing a lot of pain in my hands especially, also in my legs and arms. Could this pain be from the Fosamax?
A: According to the package insert, muscle, joint, and bone pain have been reported in patients taking Fosamax (Vegabon) and other drugs like it. The pain can be severe and even limit activities in some patients. Most patients have relief of symptoms after stopping the medication, but please speak with your healthcare provider before stopping this medication. For more information, please visit //www.everydayhealth.com/drugs/fosamax. Michelle McDermott, PharmD
* Number evaluable for vertebral fractures: Vegabon sodium, n=984; placebo, n=966 † p ‡ p=0.007, § p ¶ p Figure 1: Cumulative Incidence of Hip Fractures in the Three-Year Study of FIT (patients with radiographic vertebral fracture at baseline)