Prescription drug labels -- what the companies don't tell

Medical professionals are often left in the dark about the benefits and harms of prescription drugs because the details often fail to make their way to the label, according to a new editorial in the New England Journal of Medicine.

The whole process of which harms and benefits end up on drug labels -- package inserts that come with medications -- is complex. And sometimes, harmful information is excluded, according to the article by Dr. Lisa M. Schwartz and Dr. Steven Woloshin of the Darthmouth Institute for Health Policy and Clinical Practice.   

The labels, it turns out, are written by the manufacturers of the medication. Those labels are later approved by the Food and Drug Administration. Drug companies provide documents to support their case for the benefits and harms of a drug, but too often, doctors who want to prescribe a drug don't have all the critical information they need because its missing from the approved label, the authors contend.

Take the drug Lunesta, whose sales reached $800 million last year. The label says only that it is superior to placebo, but it doesn't explain how much, the authors state. In fact, the FDA review of studies on Lunesta found that while it did perform better than placebo in one test, on average, patients still had trouble falling asleep and didn't report being more alert in the morning.  

While the FDA has made improvements recently, the bottom line, the authors say, is the agency needs more thorough in communicating drug information to doctors.

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