published Friday, February 3rd, 2012

A worrisome recall

Birth control pills, in the main, are effective and safe. The experience of millions of women has proved that to be the case. To be effective though, the prescription medication must be taken in a precise manner dictated for the most part by the way the pills are packaged. The manufacturer packages pills with active and inert ingredients in the order in which they are to be taken. Any deviation can increase the risk of an unplanned pregnancy. No wonder, then, that Pfizer's recall of about 1 million packets of birth control pills because of a "packaging error" is causing such concern.

The Wednesday recall affects, the manufacturer reports, 14 lots of Lo/Oval-28 pills and 14 lots of norgestrel, its generic equivalent. The pills come in blister packs containing 28 doses to be taken in order -- 21 containing hormones and seven inactive pills, which women take to help stay on track. The pills generally are color-coded -- pink for active ingredients, white for inactive. At least one user, however, reported that her blister pack had a pink pill where a white one should have been.

Pfizer's recall announcement stated the obvious. "As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. The company suggested that women using the affected packets should immediately begin using a "nonhormonal" form of contraception. Hopefully, that information and instruction won't be too late for some women.

The recall affects pills made and packaged by Pfizer and marketed by Akrimax Rx Products. The brands affected are not among the most commonly prescribed brands of birth control, and the company now says that it believes that only about 30 of the about 1 million packages recalled may actually have been affected. Even if that proves to be the case, that's 30 too many when failure of the pills can lead to life-altering and life-long consequences.

The recall is another reminder that even rigorous, government-mandated inspection programs for industries whose products directly affect the health and safety of consumers can fail. There obviously is room for improvement.

Consumers, then, must be aware of the possibility of a hazard, though it is admittedly difficult for them to easily identify a problem in the case of a complex product such as a prescription drug. Pfizer says it has corrected the problem that led to the "packaging error." That's cold comfort to the women who could be adversely affected by the mistake.

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