Understanding Off-Label Drug Use

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When a doctor fills in a prescription for a patient, he or she may always believe that the prescribed medication has been approved for that indication, online media reports.  While it is a fair and reasonable belief, the notion may not always be true.  An emerging study shows that in about five written prescriptions of commonly used medications in the United States, at least one has been dispensed for a specific indication that does not bear a formal approval from the consumer protection agency.  Off-label drug use, as this medical practice is known, has been especially common in cancer treatment.  A previously conducted study, which showed how bisphosphonates might ease pain for those with bone metastasized prostate cancer, could be an example of off-label drug use through bisphosphonates.

Off-label drug use happens when a person’s health care provider prescribes a medication for an indication that has not been approved by the US Food and Drug Administration, according to medical experts.  It is the act of using or administering a drug in a way that has not been specified in the FDA-approved packaging insert or product label.  All FDA-approved medications distributed in the US carry an individual drug label comprising of a written report with specific details and instructions about the drug including its basic information, approved doses, and how it should be administered for a certain medical condition.

The off-label use of a drug while is not being regulated by the FDA, is not illegal in the US and in some other countries, medical experts say.  Patients who may have rare diseases or cancer may find the most benefit out of the medical practice, according to cancer specialists.

While it may be beneficial in some areas, the use of drugs outside their approved indications may bring about unnecessary ill effects.  For instance, the off-label use of Fosamax as treatment for hypercalcemia (excessive blood calcium levels), and cancer that has spread or metastasized to the bones, may also expose a cancer patient to the bisphosphonate drug’s inadvertent effects.  The Fosamax Lawsuit Help Center bears current and comprehensive information involving the side effects and legal claims related to the blockbuster osteoporosis drug.

URL References:

webmd.com/a-to-z-guides/features/off-label-drug-use-what-you-need-to-know

cancer.org/Treatment/TreatmentsandSideEffects/TreatmentTypes/Chemotherapy/off-label-drug-use

osteoporosis.emedtv.com/fosamax/fosamax-uses-p3.html

mayoclinic.org/news2012-rst/7015.html

medicaldaily.com/news/20120806/11316/off-label-drug-use-prescription.htm

consumerreports.org/health/resources/pdf/best-buy-drugs/money-saving-guides/english/Off-Label-FINAL.pdf

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Fosamax and Other Biphosphonate Drugs Potentially Increase the Risk of Atypical Femur Fractures: Study Finds

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A certain group of drugs may be potentially linked to spontaneously-occurring fractures, a new study finds, after looking upon the possible association of atypical fractures of the femur bone to the use of bisphosphonates. Although the results indicate that taking bisphosphonates and fractures may be related, the researchers also reportedly note that the degree of the risk remains unclear and may still be of minimum extent.

Bisphosphonates are an antiresorptive class of drugs that primarily functions by altering the formation and breakdown of the bone cycle in the body, according to medical experts.  Improving and sustaining bone tissue for strength, and fewer occurrences of fractures are among the reasons these bone-building medications are usually prescribed.

The research team, which has had their research published in the online edition of the Archives of Internal Medication, gathered and analyzed admission radiographs and medical treatment records of over 470 cohorts.  The retrospective study reportedly involved fracture patients –aged 50 years and above — who were admitted at a single university medical center between 1999 and 2010, and a controlled group of about 200 healthy individuals who have not sustained any fractures.  Within a study cohort of 477 participants, the researchers determined atypical femur fracture patients of 39 people, and classic femur fracture sufferers of 438 heads Among the subtrochanteric fracture patients, 32 people or 82.1 percent were treated with bisphosphonates, while 28 patients or 6.4 percent who suffered from classic femoral factures received bisphosphonate medication.

After identifying the patients based on the lengths of their treatment, the Sweden-based research team found that the odds for an atypical fracture over a common fracture was 35 to one for treatment of two years or less, 46 to nine for treatment from of two to five years, 117 to one for treatment ranging from five to nine years, and 175 to 7 treatment of more than nine years, all odds reportedly compared to non-treatment.

Fosamax (alendronate), Actonel (risedronate), Aredia (pamidronate), and Boniva (ibandronate) were among the biphosphonate medications that were reportedly used by the patients in the study.

“In conclusion, we have demonstrated that the association between bisphosphonate treatment and the occurrence of atypical fractures of the femur is highly likely and that the duration of such treatment significantly correlates with augmented risk. However, the incidence rate was very low, and the absolute benefit to risk ratio of bisphosphonate use remains positive,” concluded the authors.

URL References:
archinte.jamanetwork.com/article.aspx?articleid=1160668
medicalnewstoday.com/articles/245762.php
nature.com/bonekey/community/2012/05/more-data-on-atypical-femoral-fractures-and-bisphosphonate-use/
specialtypharmajournal.com/index.php?option=com_content&view=article&id=3083:bisphosphonate-linked-with-atypical-femur-fractures&catid=346:osteoporosis&Itemid=558

A Rundown on the Potential Adverse Effects of Fosamax

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Following its release into the United States consumer market in late 1995, Fosamax – also known by its generic equivalent alendronate — has been looked upon as a miracle therapy by millions of Americans suffering from a bone disease or who may be at risk of a certain muscoskeletal disorder.  Developed and widely sold by one of the leading drug makers Merck and Co., it has been frequently utilized by osteoporotic patients, especially postmenopausal women.

A formulation classified within the class of drugs known as bisphosphonates, the anti-resorptive drug mainly works by changing the cycle of bone formation breakdown in the body, and aids in inhibiting bone loss while sustaining and maintaining bone mass – a prevention commonly taken to impede detrimental and limiting bone fractures.

As the first bone-strengthening medication to enter the retail industry, Fosamax was approved for indications such as prevention and treatment of osteoporosis in men and postmenopausal women, and Paget’s disease of the bone. Fosamax has been highly regarded as a bone-sparing medication in the bisphosphonates class of drugs.

Less Severe Side Effects of Fosamax

As were the other formulations, Fosamax also bear certain side effects that may counter its most-sought benefits, according to medical experts.  Although many people may possess a more flexible boundary when it comes to medication effects, some patients may still go through the unanticipated adverse effects of Fosamax.

The most common side effects involving the use of Fosamax include mild heartburn, bloating, mild nausea, vomiting or stomach pain, diarrhea, gas or constipation, mild joint pain, swelling hands and feet, dizziness, eye pain or headache.

Potentially Harmful Adverse Effects Linked to Fosamax

Deteriorating Jawbone

Bisphosphonates such as Fosamax have been reportedly connected to a number of unanticipated side effects, after it obtained approval from the United States Food and Drug Administration, to enter the country’s retail market. Numerous studies may have found a possible association with the intake of Fosamax for a long duration and the occurrence of deteriorating jawbone problems in some patients, a condition also called as osteonecrosis of the jaw (ONJ).

Incapacitating Pain

Taking Fosamax and other bisphosphonates drugs has also been reported to cause an increased likelihood of experiencing crippling pain in the bone, joint, and muscle in some patients, reportedly harboring a safety alert from the US FDA, highlighting the importance of diagnosis and treatment to doctors and users alike.

Atypical Fractures

A 2011 research published in the Journal of the American Medical Association revealed an increased risk of low-energy fractures nearly three times higher in postmenopausal women who have been taking bisphosphonates for more than five years, compared to patients who have been under the medication for less than three months.  Also known as atypical fractures, these serious injuries are typically found in older adults with declining health, according to medical journals.  Biphosphonate medications reportedly used in the study were Actonel (risedronate), Didronel (etidronate), and Fosamax (alendronate sodium).

Irregular heartbeat

Another previously conducted study which was documented in the Drug Safety journal, has also examined the possible connection involving bisphosphonates and the occurrence of atrial fibrillation (irregular and often rapid heart rate).  Although atrial fibrillation has been observed in some of the study cohort, the research team explained that the benefits offered by bisphosphonates may still outweigh its risks especially to those who may need aid for fracture prevention (osteoporotic women, concluding that the study findings were conflicting.

What Experts Have to Say

Although the bisphosphonates have been surrounded with controversies, medical experts highlight that many patients may still benefit from the bone-protecting qualities of these drugs.  Although the aforementioned potential adverse effects may not be comprehensive, experts encourage patients to work a collaborative effort with their health care team as their first source of information as a regard a medications benefits and possible risks, and report any signs of adverse effects for subsequent treatment.

URL References:
rxlist.com/fosamax-drug/indications-dosage.htm
drugs.com/fosamax.html
cancerhelp.cancerresearchuk.org/about-cancer/cancer-questions/about-bisphosphonates-and-jaw-problems#link
mayoclinic.com/health/fosamax/AN01379/
medicalnewstoday.com/articles/93195.php
medpagetoday.com/Endocrinology/Osteoporosis/13665
nejm.org/doi/full/10.1056/NEJMc0707493
breastcancer.org/tips/new_research/20110223.jsp