By Gordon Gibb Leavenworth, KS The troubles over Fosamax are bound to intensify, with the approval of a new, generic form of the drug that is alleged to cause Osteonecrosis of the jaw ONJ , a debilitating disease of the jawbone. With its patent for alendronate having expired, just days ago the US Food and Drug Administration FDA announced the licensing of the first generic versions of the drug.
Fosamax, manufactured for over a decade by Merck, has been doing quite well with its osteoporosis drug, thank you. In fact, in spite of a basket of other drugs available designed to fight bone loss, WHEC Television in Rochester, New York reported that more than half of all women in the United States suffering from osteoporosis take Fosamax. Other sources suggest that more than 10 million men and women have taken Fosamax.
This number is bound to increase, now that the patent has expired. Merck no longer has exclusivity. Thus, there will be new, and most likely cheaper versions of Fosamax out there.
What hasn't changed is the formulation. And that could be a problem, given the number of patients having experienced, and are suing Merck over the development of osteonecrosis, or bone death in the jawbone. There are other side effects as well, which appear to be the basis of a lawsuit launched against Merck by a Connecticut woman over claims that Fosamax caused serious side effects. Take Fosamax exactly as prescribed by your doctor. Fosamax is taken either once daily or once per week. Follow all directions on your prescription label.
Do not take this medicine in larger or smaller amounts or for longer than recommended. Take Fosamax first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take this medicine only once per week, take it on the same day each week and always first thing in the morning. Take with a full glass 6 to 8 ounces of plain water. Do not use coffee, tea, soda, juice, or mineral water.
Do not eat or drink anything other than plain water. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one. Do not crush, chew, or suck on an Fosamax tablet. Swallow the tablet whole. For at least 30 minutes after taking Fosamax: Do not lie down or recline. Do not take any other medicine including vitamins, calcium, or antacids. Pay special attention to your dental hygiene while taking Fosamax.
The risk of ONJ may increase with duration of exposure to bisphosphonates. For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon.
In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Atypical Subtrochanteric And Diaphyseal Femoral Fractures Atypical , low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with bisphosphonates.
Atypical femur fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs.
A number of reports note that patients were also receiving treatment with glucocorticoids e. Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb.
Before initiating treatment, the gonadal hormonal status of both men and women should be ascertained and appropriate replacement considered. A bone mineral density measurement should be made at the initiation of therapy and repeated after 6 to 12 months of combined FOSAMAX and glucocorticoid treatment. Osteoporosis Recommendations, Including Calcium And Vitamin D Supplementation Instruct patients to take supplemental calcium and vitamin D, if daily dietary intake is inadequate.
Dosing Instructions Instruct patients that the expected benefits of FOSAMAX may only be obtained when it is taken with plain water the first thing upon arising for the day at least 30 minutes before the first food, beverage, or medication of the day.
Instruct patients not to chew or suck on the tablet because of a potential for oropharyngeal ulceration. Instruct patients to swallow each tablet of FOSAMAX with a full glass of water ounces to facilitate delivery to the stomach and thus reduce the potential for esophageal irritation. Instruct patients to drink at least 2 ounces a quarter of a cup of water after taking FOSAMAX oral solution, to facilitate gastric emptying.
Instruct patients not to lie down for at least 30 minutes and until after their first food of the day. Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems. Instruct patients that if they develop symptoms of esophageal disease such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn they should stop taking FOSAMAX and consult their physician. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.
These doses are equivalent to approximately 0. The relevance of this finding to humans is unknown. Alendronate 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, alendronate gave equivocal results. FOSAMAX should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. The amount of bisphosphonate incorporated into adult bone, and hence, the amount available for release back into the systemic circulation , is directly related to the dose and duration of bisphosphonate use.
There are no data on fetal risk in humans. However, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception , the particular bisphosphonate used, and the route of administration intravenous versus oral on the risk has not been studied.
Reproduction studies in rats showed decreased postimplantation survival and decreased body weight gain in normal pups at doses less than half of the recommended clinical dose.
Sites of incomplete fetal ossification were statistically significantly increased in rats beginning at approximately 3 times the clinical dose in vertebral cervical , thoracic , and lumbar , skull, and sternebral bones. No similar fetal effects were seen when pregnant rabbits were treated with doses approximately 10 times the clinical dose. Both total and ionized calcium decreased in pregnant rats at approximately 4 times the clinical dose resulting in delays and failures of delivery.
Protracted parturition due to maternal hypocalcemia occurred in rats at doses as low as one tenth the clinical dose when rats were treated from before mating through gestation. Maternotoxicity late pregnancy deaths also occurred in the female rats treated at approximately 4 times the clinical dose for varying periods of time ranging from treatment only during pre-mating to treatment only during early, middle, or late gestation; these deaths were lessened but not eliminated by cessation of treatment.
Calcium supplementation either in the drinking water or by minipump could not ameliorate the hypocalcemia or prevent maternal and neonatal deaths due to delays in delivery; intravenous calcium supplementation prevented maternal, but not fetal deaths. Nursing Mothers It is not known whether alendronate is excreted in human milk.
The safety and efficacy of FOSAMAX were examined in a randomized, double-blind, placebocontrolled two-year study of pediatric patients, aged years, with severe osteogenesis imperfecta OI. The mean baseline lumbar spine BMD Z-score of the patients was In FOSAMAX-treated patients, bone histomorphometry data obtained at Month 24 demonstrated decreased bone turnover and delayed mineralization time; however, there were no mineralization defects. The oral bioavailability in children was similar to that observed in adults.
During the month treatment period, vomiting was observed in 32 of
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