The Boom in Medications Brings Rise in Fatal Risks nytimes.com
Excerpts:
The arthritis drug Celebrex, which was approved by the F.D.A. in January and has already been prescribed to more than two million people, is repeatedly being confused by doctors and pharmacists with two other drugs: Cerebyx, an anti-seizure medication, and Celexa, an antidepressant. The agency has already received 41 reports of the wrong prescription being filled; in one, an 81-year-old woman wound up taking two antidepressants for a month.
"We haven't had any serious injuries, thank goodness," said Dr. Jerry Phillips, the F.D.A. official who keeps tabs on medication errors, referring to Celebrex. He is trying to persuade the Monsanto Company, which manufactures the drug, to change Celebrex's name, a difficult task given that the company has spent tens of millions of dollars advertising and promoting the medication.
At the same time, Dr. Phillips said, the food and drug agency is planning to install computer software that will analyze proposed drug names to avoid such confusion in the future. But at least one expert, Dr. Leape of Harvard, said it should have taken that step years ago.
"The F.D.A. has essentially focused on the safety of the product, whereas the major threat has to do with safety of use and misuse," Dr. Leape said. "Their point of view has been that it is safe and effective when used as directed, and the directions are on the label, so read it. We have come to them repeatedly and said; 'That is not enough. People make mistakes, even when it is all there.' " |