A new study finds that several commonly prescribed meds are linked to a significantly higher risk of premature death. Moreover, those who took the pills were 35 percent more likely to develop cancer.
Ed Silverman, Pharmalot, Feb 28, 2012
Take a sleeping pill and never wake up? Not quite. But a new study finds that several commonly prescribed meds are linked to a significantly higher risk of premature death. Moreover, those who took the pills were 35 percent more likely to develop cancer. The pills in question include Ambien, Lunesta, Restoril and Sonata, as well as benzodiazepines, barbiturates and sedative antihistamines.
The findings, which were published today in BMJ, indicate that even those people who took fewer than 18 doses a year had a 3.5 increased risk of death. People who took between 18 and 132 doses annually faced a more than fourfold risk and the likelihood of premature death was more than fivefold for those who took more than 132 doses.
Given that about 6 percent to 10 percent of US adults took sleeping pills last year, a rough “order-of-magnitude estimate” suggests that, last year, these hypnotics may have been associated with between 320,000 to 507,000 excess deaths in the US alone. “We cannot be certain what portion of the mortality associated with hypnotics may have been attributable to these drugs, but the consistency of our estimates across a spectrum of health and disease suggests that the mortality effect of hypnotics was substantial,” they conclude.
The results may amount to yet another nightmare for the drugmakers that market sleeping pills. Earlier studies suggested that some sleeping pills were linked to sleepwalking and sleepdriving, serious falls and so-called “night-eating syndromes” in which people would binge on food while asleep. Five years ago, the FDA ordered labeling changes on various pills to mention sleepdriving (see this).
The researchers examined the medical record of 10,531 people who took sleeping pills and were covered by the Geisinger Health System, a provider that serves 41 mostly rural counties in Pennsylvania. Over two and a half years, they compared death rates with 23,674 people who did not take the drugs, but were matched for age, health and background. The average age was 54.
Despite the sensational conclusions, there were limitations. For instance, the researchers were unable to take depression, anxiety and other emotional factors into account, because these diagnoses are confidential under Pennsylvania law. And while the research may have established a statistical link, the study did not definitively prove the pills caused death or cancer. [UPDATE: And they also note confounders that would increase the risk of death, such as asthma, heart failure, cardiovascular disease and obesity.]
Meanwhile, the researchers also note that the “preferable randomized controlled trial method for assessing hypnotic risks may be impractical due to ethical and funding limitations… A randomized clinical trial of sufficient duration and size could provide definitive evidence for or against the disturbing mortality hazards suggested by our study.
“Some American NIH reviewers have opined that a randomized trial of hypnotic lethality would be unethical. No such trial has ever been mounted, perhaps for reasons similar to the absence of randomized trials of cigarettes and of skydiving without parachutes. Absent randomized trials of sufficient dimensions, we must be guided by observational data for hypnotics, as we have been guided by similar data for cigarettes,” they write.
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