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What is normal inr on coumadin."
The FDA's current stance is that as much a third of the population will experience "acute and/or recurrent cough with or without wheezing," as the agency defines acute, which is characterized by a cough that occurs for three or more short occasions. "This is an indication for antihistamine treatment or an antitussive inhaler," said a CDC spokesperson.
But that has not deterred patients. A survey in 2007 published Pediatrics found that 25 percent of more than 2,000 physicians felt "more important" than safety and efficacy. Among parents, 45 percent believed a cough with or without wheezing was the only sign of serious medication side-effects; a few felt that it was the reason their child hadn't been able to play the violin after a bout of asthma. When told a study that suggested the opposite—that people taking more antihistamines experienced less cough—many were surprised and upset. "It's just ridiculous. It's not the most important thing," one father told the New England Journal of Medicine about his son's coughing.
The problem is that this way the FDA interprets data: A study showing more antihistamines is good—that's what the scientists found. So FDA allows doctors to prescribe the drugs with or without a "clinical review" (the process involves an interview with a pharmacist and written permission from the FDA) but doesn't require them to monitor those outcomes. That's an interpretation that can be challenged in court under section 520 of the Food, Drug, and Cosmetic Act, says Marcia Angell, the former editor in chief of the New England Journal Medicine. An "aspirin is a drug. If my doctor wants me to take a drug suppress the cough, he has every right to prescribe the drug."
The current regulations make it possible to use the drugs in much higher doses than is required to prevent anaphylactic reactions, the type of injury that occurred in this New York woman named Amy Pinsky, who suffered what doctors deemed "cardiac adverse events"—heart and breathing-rate changes that may reflect the effects of drugs—with antihistamines. As she had become worse, was taken into the emergency room, where surgeons removed a portion of her aorta. "I don't know what happened, but they said she was an asperger's patient," her father, Michael Pinsky, says. "She had taken antihistamines as well … and a month later she died." It's still unclear what caused the fatal allergic reaction; investigators said they had not found an underlying medical condition. Her parents suspect a genetic component.
Dr. Michael Sharpe said the FDA had asked him to review its existing rules and suggest revisions, but said he doubted physicians would follow his suggestions. "It is my strong concern that it will become commonplace," he said.
This was not Dr. Sharpe's first call to change the rules for anti-itch medications. Until the mid-2000s, doctors could recommend any combination of drugs for allergic symptoms, although many experts considered this to be unsafe. When doctors tried it, there was nothing to control for the side effects and, of course, there was no long-term data to prove how safe these treatments actually were.
"People should be able to have all of their medications with no risk
pharmacy online usa viagra of harm," says Dr. Sharpe, who was president of the American Association for Study of Addiction. Yet that didn't happen. "We need a systematic review of the effectiveness and adverse effects of these drugs," he said. "The drugs should go back to the drawing board."
Dr. Sharpe says the FDA also needs to provide more oversight of the drug companies that manufacture antihistamines to assure their marketing plans are compliant. "How can we trust the manufacturers to do right by the public?"
This article was reported in partnership with the Investigative Fund at Nation Institute.
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