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Medical patch users discover danger beneath the surface.

Article Excerpt
"I'm on the patch," say cigarette smokers every January, when the inevitable New Year's resolutions roll around. Wearing a patch that transmits nicotine through the skin to ease a smoker's urge to light up is generally viewed as a benign way to combat a serious health problem.

But medical patches can be dangerous--whether they deliver nicotine or strong medicine such as opiate painkillers, anesthetics, nitroglycerin, birth control, and male and female hormones. Patients and health care providers alike often misunderstand the patches' proper use, meaning users may receive the wrong dose of medication. And defective design caused a recent product recall.

The first transdermal patch, to treat motion sickness, received FDA approval in 1979. It delivered scopolamine over a period of three days. In 1991, the agency approved nitroglycerin patches for treating angina (heart pain), as well as four types of nicotine patches. Total sales of the nicotine patches in their first year on the market reached almost $1 billion.

Patches consist of one or two pieces. Some have a medicated center pouch held tightly against the skin by an adhesive ring (like a round Band-Aid with its sterile-pad center); others use a separate adhesive overlay to hold the patch in place. They deliver doses of drugs over time, usually between one and seven days per patch.

Ideally, a patch is designed to "deliver the drug at an adequate and reasonably constant rate for a sustained period of time, should not irritate the skin or cause allergic reaction, and should deliver most of the drug it contains." (Alza Corp. v. Mylan Labs., Inc., 310 F. Supp. 2d 610, 614 (D. Vt. 2004).)

Patches are a popular choice with physicians because drugs delivered transdermally are absorbed better so smaller doses can be used, maintaining a steady level in the bloodstream, and causing fewer side effects. If side effects do occur, the medicine can quickly be discontinued by removing the patch, and patients' compliance is better because they take a dose every few days rather than...