| TO
WELCOME
TO CONTENTS |
|
Everything you ever wanted
to know about Fosomax's chemistry can be found at http://www.rxlist.com/cgi/generic/alendron.htm#id-S003232-DI
(Don't
miss the linked blue "tabs" at the top)
For a simplified explanation
of Fosamax and osteoporosis in non-medical language see
http://healthanswers.telstra.com/drugdata/DrugDetails.asp?ID=3934
| June 2001
http://womenshealth.medscape.com/39366.rhtml?srcmp=wh-062201 ONCE-WEEKLY ALENDRONATE IS EFFECTIVE WITH FEWER SIDE EFFECTS Osteoporosis patients experience fewer upper gastrointestinal problems and are more likely to comply with a once-weekly than a once-daily dose of alendronate, according to new research. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fosamax side effects not
discovered during clinical trials:
http://www.merck.com/product/usa/fosamax/cns/product_info/fpi/fpi_adverse.html Post-Marketing Experience The following adverse reactions have been reported in post-marketing use: Body as a Whole: hypersensitivity reactions including urticaria and rarely angioedema. Gastrointestinal: esophagitis,
esophageal erosions, esophageal ulcers, rarely esophageal stricture,
and oropharyngeal ulceration. Rarely, gastric or duodenal ulcers, some
severe and with complications have been reported (see WARNINGS,
PRECAUTIONS, General and
Skin: rash (occasionally with photosensitivity). Special Senses: rarely uveitis. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
| http://www.ama-assn.org/sci-pubs/sci-news/1998/snr1223.htm#joc80627
THERAPY FOUND TO DECREASE RISK OF FRACTURES FOR WOMEN WITH LOW BONE MINERAL DENSITY But therapy does not reduce risk for women with higher BMD CHICAGO — Four years of therapy with alendronate sodium [fosamax]increased bone mineral density (BMD) and decreased the risk of vertebral deformity in women with low BMD, but the risk of fractures was not reduced among women in the study overall, according to an article in the December 23/30 issue of The Journal of the American Medical Association (JAMA). ......They conclude : "In women with low BMD but without vertebral fractures, four years of alendronate safely increased BMD and decreased the risk of first vertebral deformity. Alendronate significantly reduced the risk of clinical fractures among women with osteoporosis [defined as less than -2.5SD at the femoral neck] but not among women with higher BMD." |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
| http://www.interchg.ubc.ca/jauca/pages/letter20.htm#alendronate
Major adverse effects: The placebo-controlled trials reported no increased evidence of adverse events including upper gastrointestinal problems with alendronate. Adverse events from post-marketing data reveal a major concern with severe esophageal injury (51 reports) most often occurring during the first month of therapy. Dose and cost: Osteoporosis: 10 mg daily ($1.75/day). Take on an empty stomach with >200 ml of water in AM; remain upright for > 30 minutes after ingestion to prevent esophageal injury. Paget's disease of bone, 40 mg daily ($4.66/day) for 6 months. Conclusions: In women with extremely low BMD, 100 need treatment for 3 years to prevent 1 fracture detected on x-ray. In women with a previous pathologic fracture, 22 need treatment for 3 years to prevent one symptomatic fracture. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Extract
from letter to Journal of the American Geriatrics Society warning of Fosamax
related injury at http://www.wwilkins.com/AGS/0002-861412-98ltrs.html#page1581
Positive effects of alendronate on bone mineral density and the incidence of fractures have been shown in postmenopausal women with osteoporosis. Clinical trials have shown that alendronate-related esophageal injuries are uncommon. However only after trials, when a drug is used in sicker patients in a clinical setting, do the true risks become apparent. A recent cohort study showed that various esophageal injuries are rather common (1.3%) although esophageal stricture seems rare (2 in 1523 patients). The present analysis has shown that the recommendation that alendronate be discontinued immediately after onset of symptoms of esophageal injury has not always been followed in clinical practice. This may be caused by patients' as well as doctors' lack of knowledge about the risk of alendronate-related esophageal injuries. We feel there is an urgent need for information about the risks of alendronate-related esophageal injury to be disseminated to both patients and clinicians. Qun-Ying Yue, MD, PhD, Orjan Mortimer, MD; Dept of Pharmacoepidemiology, Information and Inspection Medical Products Agency Uppsala, Sweden |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
The studies did not show that there were necessarily less pain or disability due to the increase bone mass and loss of height. Also, with hip fractures the question has not yet been addressed. Although past epidemiological data predicts that the amount of bone density increase associated with the drug may result in less hip fractures. So Does It Work Or Not?
In short, the statistical significance in studies found in this study (of Fosamax increasing bone density) doesn't mean that the drug will be significant in the common English use of the word. It doesn't mean it will make any difference in your life, if you take it. In the vertebral bone studies, there were less fractures and less bone loss and height loss. The word fracture sounds terrible, but in reality if you have a minor decrease in you vertebral bones, you may have no idea the problem is there. There was no evidence that Fosamax patients with the lesser bone loss were having less problems with the nerve pinching or other problems. Also, while the percentage of vertebral fracture were about cut in half, it means the percentage of women affected went from 6% to 3%. In summary, only 3% of the women could possibly be preventing clinical disease (pinched nerve) by taking this drug, and we are not sure if any of them actually are. In the hip, we have no clinical data about as to whether or not it prevents hip fractures. It also doesn't tell us whether Fosamax increase the odds of having successful surgical repair, if one does break a hip. Whether or not a person with a hip fracture will be able to heal by having screws put in or having a hip replacement is dependent on having strong enough bone to anchor these devices. We only know it increases bone density by 5-6%. We don't know if that 5-6% is enough to make a difference in fractures and walking ability. Should I take it?
|