Heart Drug Causes Unexpected Deaths

A drug called spironolactone that was shown in 1999 to reduce deaths and hospitalization for patients with congestive heart failure may have actually taken lives rather than saved them. After the 1999 clinical drug study, which showed that the drug prevented or postponed 11 deaths and eight hospital admissions for every 100 patients treated, prescriptions for the generic drug jumped more than fourfold over an 18-month period. However, along with the jump came a tripling of hospital admissions and deaths resulting from dangerous elevations of potassium--a known side effect of spironolactone. Deaths from the side effect, called hyperkalemia, rose to two per thousand in 2001, up from 0.3 per thousand in 1994.

The major point to be seen here is that what occurs in a clinical trial does not always occur in real-life situations. Many of the patients who received the drug in reality, such as people who were at an increased risk of the potassium problem, would not have been allowed to participate in the clinical trial because patients in clinical studies are typically carefully selected to show the maximum benefits of the drug at stake. So when confronted with relying on clinical studies, which are often plagued by conflicts of interest, to determine whether a drug is right for you, it certainly seems wise to seek out unbiased information to make an informed decision.

New England Journal of Medicine August 5, 2004;351:543-551

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