Dr. Jon Duke of Indiana University was trying to figure out why his patient's blood platelets were abnormal. Could it be a side effect of one of the dozen drugs the man was taking, a number that is not uncommon among elderly people?
He began reading the label of each and every drug. "I was just overwhelmed," Dr. Duke said. The lists of possible adverse reactions went on and on.
Now he knows why. In a new paper in the Archives of Internal Medicine, Dr. Duke and two colleagues report that the average drug label lists 70 possible side effects and some drugs list more than 500. "This was beyond even what I'd expected," he said.
For anyone who has ever had to watch an entire Flomax commercial, the listing of a drug's side effects is almost a joke. But the question is, why does the list continue to grow?
It's not as if the problem hasn't been addressed. In 2006, troubled by the ever-expanding lists of side effects, Dr. Jerry Avorn and Dr. William Shrank of Harvard Medical School wrote a paper in The New England Journal of Medicine calling it "linguistic toxicity."
That same year, the Food and Drug Administration suggested making labels clearer with a new format and advised drug makers: "Exhaustive lists of every reported adverse event, including those that are infrequent and minor, commonly observed in the absence of drug therapy or not plausibly related to drug therapy should be avoided."
But, Dr. Duke found, instead of decreasing in the years after the agency issued guidelines, the average number of side effects rose to 94, as compared to 67 for those whose labels predated the new format. Some potential complications are weird, like "compulsive gambling." Others, like "nausea" are so common — it's listed on 75 percent of drug labels — that they almost seem like a universal issue.
Some were adverse reactions that showed up in clinical trials before a drug was marketed. Others were conditions patients reported when they were taking the drugs that may — or may not — have been caused by the drugs. Often there is no way to know why or how a side effect got reported.
Listing every inkling of an adverse reaction can help drug companies in lawsuits, Dr. Duke said. If someone sues about a side effect that is listed in the drug's package insert, the company can say patients had been warned.
The Pharmaceutical Research and Manufacturers Association says the companies are just complying with the F.D.A.'s requirement that they reveal all of a drug's risks, "even if a clear causal connection between the medicine and the observed adverse event cannot be fully established," a spokesperson for the group wrote in an e-mail.
But, said Dr. Christine Cheng, a doctor of pharmacy at the University of California in San Francisco, what is happening is a case of "information overload." Dr. Cheng wrote an invited commentaryto accompany Dr. Duke's paper.
And the F.D.A., in an e-mail, said "extensive lists of rare and minor adverse events for which there are no data to support a causal relationship" are not useful.
Patients agree.
Jim Murrell, a 54-year-old telecommunications consultant who lives in the Atlanta suburbs, says he wants to know all about adverse drug reactions but he has decided the labels are not helpful; he looks for better sources on the Internet.
"I took a medication that had the side effect of drowsiness," he said. "I read a little further and saw it had another side effect. Insomnia. One medication had diarrhea as a side effect and it also had constipation."
"It makes no sense," Mr. Murrell said.
"What I need to know is probably buried somewhere in there," he added. "But what I don't need is all the information that is probably in there because, I don't know, maybe there's a lawsuit somewhere."
http://www.nytimes.com/2011/0605/weekinreview/05drugs.html?hpw=&pagewanted=print
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