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Compounded drugs are dangerous concoctions, critics say.

Article Excerpt
Nostalgia may sustain the idea of a friendly neighborhood druggist preparing a personal bottle of cough syrup for Mrs. Smith when she requires it--but through rose-colored glasses is no way to look at today's compounded drugs.

Pharmacists may legally compound customized prescription medication from scratch--common examples include hormone products, antibiotics, steroids, anesthetics, and drugs to treat glaucoma, asthma, iron-deficiency anemia, and erectile dysfunction. This is routine practice when special formulations aren't available commercially. For instance, if a patient is allergic to an ingredient in a mass-produced drug, his or her doctor can write a prescription for the drug without that ingredient and a pharmacist will prepare the compound.

But consumers may not realize that a compounded drug isn't necessarily a therapeutic twin of the original, minus whatever troublesome trait was eliminated. By 2004, the FDA had collected at least 200 reports of adverse reactions to compounded drugs, and an agency study that year showed that one-third of compounded drugs failed to meet basic standards of quality.

Accounts of deaths and injuries have been mounting. In 2001, three California patients died of meningitis after getting contaminated steroid shots made by a compounder. In Nevada, erectile dysfunction drugs from a compounder sent several men to the emergency room with priapism. Last year, patients and their families sued a Fredericksburg, Virginia, hospital and the compounding pharmacy that made a contaminated drug that doctors used in heart bypass surgery. Four patients died and seven suffered injuries.

The nine lawsuits filed in the Virginia incident (most settled confidentially) represent just a few of the suits seeking compensation for injuries caused by compounded drugs. And as safety concerns grow, the FDA is taking a closer look at the compounding industry.

Currently, the FDA allows compounding but does not regulate it because it has authority only over pharmaceutical manufacturers. State boards of pharmacy are responsible...

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