Vital Signs: Nov. 5

Vital facts may be missing on drug labels

Federal officials who approve drugs review an enormous amount of data about their effectiveness and harmful side effects, but critical information often fails to reach the doctors who prescribe them, two Dartmouth Medical School researchers write in the Oct. 29 issue of The New England Journal of Medicine.

In the case of the sleeping pill Rozerem (ramelteon), for example, one review document from the Food and Drug Administration states that the drug made "no significant difference in time to fall asleep" and that patients "do not seem to recognize any benefit from treatment."

But the reviewer's uncertainty about the drug's effectiveness is not reflected in Rozerem's label, which does not include efficacy data from a clinical trial of 848 young and middle-age adults; that trial found that the drug was no more effective than a placebo, and users actually took a minute longer to fall asleep than those on the dummy pill.

Dr. Lisa M. Schwartz and Dr. Steven Woloshin, who wrote the essay, said that the FDA revised the design of drug labels in 2006 to highlight appropriate uses and warnings but that more needed to be done.

An agency spokeswoman said that it was "actively engaged in talking to stakeholders about the issue" but that there was no specific deadline for action. Officials with Takeda Pharmaceuticals, which markets Rozerem, did not respond to repeated requests for comment.

For heart attacks,

gender gap shifts

Middle-age men are at much greater risk of a heart attack than women their age, but new research suggests the gap may be narrowing.

Some 2.5 percent of men ages 35 to 54 who responded to national health surveys in the late 1980s and early 1990s reported having had a heart attack, compared with 0.7 percent of women the same age. But in more recent surveys, in 1999 to 2004, the percentages for women rose to 1 percent while dropping to 2.2 percent for men.

The researchers acknowledged that the reported increases and decreases might have been due to chance. But the lead author of the study, published in the Oct. 26 issue of The Archives of Internal Medicine, said the changes reflected an "ominous trend." And the article noted that over the same period, men's scores on a scale that predicts heart disease risk improved slightly, while women's scores worsened.

"I think everyone has been complacent that women are not at very high risk at this age," said the lead author, Dr. Amytis Towfighi, an assistant professor of clinical neurology at the University of Southern California.

A 2007 study by the same authors found that women ages 45 to 54 were twice as likely as men to report having had a stroke, a finding that challenged conventional medical thinking that women were at lower risk for stroke in midlife than men.