US Pharm. 2008;33(2):70.

Potential Drug Mixup Warning
Concerned about possible confusion between the drugs edetate diso!=dium and edetate calcium disodium, the FDA issued a public health advisory. According to the agency, child and adult deaths have occurred when edetate disodium was mistakenly given to patients instead of edetate calcium diso!=dium (calcium disodium versenate). Fatalities have also occurred when edetate disodium was used for unapproved chelation therapies and other uses not approved by the FDA.

These drugs, both of which are often referred to as EDTA, are easily mistaken for each other. Edetate disodium was approved as an emergency treatment for hypercalcemia or certain heart rhythm problems, and edetate calcium di!=sodium was approved to treat severe lead poisoning. Because of the potential for these medication errors to be fatal, the CDC recommended that hospitals determine whether or not they need to keep edetate disodium stocked in their pharmacies. The FDA also warns against using the abbreviation EDTA to avoid possible confusion between the two drugs.



Bisphosphonates and Musculoskeletal Pain
FDA is warning of possible severe and sometimes incapacitating bone, joint, and/or musculo!=skeletal pain in patients taking bisphosphonates. Severe musculoskeletal pain is included in all bisphosphonate prescribing information, but this may be overlooked by health care professionals. This could delay diagnosis, prolonging pain and/or impairment, and require analgesics.

Severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. Some patients report complete symptom relief after discontinuing the bisphosphonate; others have reported slow or incomplete resolution. This pain is in contrast to the acute phase response associated with initial administration of intravenous bisphosphonates and initial exposure to once-weekly or once-monthly oral bisphosphonates. The symptoms related to the acute phase response tend to resolve within several days with continued drug use.

The FDA says that health care professionals should consider stopping or interrupting the drug in patients presenting with severe musculoskeletal pain if they believe bisphosphonate use might be responsible for these symptoms.

Concerns over Compounded Menopause Drugs
The FDA warned seven pharmacy operations that their claims concerning the safety and effectiveness of their so-called bio-identical hormone replacement therapy , or BHRT, products are scientifically unsupported and are considered false and misleading.

According to the agency, the pharmacy operations wrongly say that their drugs, which contain such hormones as estrogen, progester!=one, and estriol, are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat Alzheimer's disease, stroke, some cancers, and other serious diseases. Estriol is not a component of an FDA-approved drug and has not been proven safe and effective for any use.

The FDA's warning does not apply to pharmacists who practice traditional compounding. All patients who use compounded hormone therapy drugs, the agency says, should discuss menopausal hormone therapy options with their health care provider.

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