Most Americans Don't Know They Can Report Bad Reactions to FDA Safety Program
WASHINGTON, April 2, 2008 /PRNewswire-USNewswire/ -- A new Consumer Reports poll shows that one in six Americans who have ever taken a prescription drug experienced a side effect serious enough to send them to the doctor or hospital, but the majority of consumers don't know they can report these side effects to the FDA, which is responsible for tracking drug safety problems.
To help make the public aware of the FDA's reporting program for drug side effects -- known as MedWatch -- Consumers Union today gave the FDA a petition signed by nearly 56,000 consumers asking that a toll-free number and website be included in all TV drug ads so people can easily report their serious side effects to the agency. CU is the nonprofit publisher of Consumer Reports.
"You can't turn on a TV today without seeing a drug ad, but those ads never mention that consumers should be reporting serious drug side effects to the FDA," said Liz Foley, campaign coordinator with Consumers Union. "What better way for the FDA to let consumers know how to report serious problems with their medications than putting a toll-free number and website in all those drug ads we're bombarded by each day?"
Congress required the MedWatch reporting information in all print drug ads when it approved a major overhaul of drug safety laws last fall, and called for an FDA study to determine if it was appropriate to include the information in TV advertisements. But that study -- due at the end of March -- has not been completed.
"As someone who lost a loved one from an adverse drug reaction but didn't know where to turn, the FDA should make it as easy as possible for people to report serious side effects," said Kim Witczak, founder of the drug safety advocacy group WoodyMatters, named after her husband.
Witczak worked with Rep. Jan Schakowsky (D-Ill.) and others to get the DTC reporting language in last fall's FDA reform bill. "If the FDA is really serious about finding out how drugs work in the millions of people who take them each day, it should be doing all it can to make sure the reporting information is included in the advertising -- not dragging its feet," Witczak said.
A national poll by the Consumer Reports National Research Center found that among consumers who have ever taken a prescription drug, one in six (16 percent) had experienced a serious drug side effect at some time in their life -- described by the FDA as a reaction that led them to visit a doctor or hospital, was life-threatening or caused a significant disability or incapacity. But only 35 percent of consumers polled were aware that serious side effects can be reported to the FDA. (To view the poll, go to http://www.ConsumersUnion.org).
Yet Americans were very familiar with drug advertising. Eight in 10 (81 percent) said they had seen or heard an advertisement for prescription drugs within the past 30 days. Among them, virtually all -- 98 percent -- viewed an ad on television.
When asked if they think prescription drug advertising should include information to report an adverse drug reaction to the FDA, 87 percent of consumers said TV ads should contain the information, and 90 percent said print ads should do the same.
"Clearly, consumers want to know how to report serious drug side effects to the FDA, and they think drug advertising is an ideal way to do that," Foley said.
Adverse event reporting by consumers is vital to signaling drug safety problems, but the FDA's reporting system, MedWatch, catches only a fraction of serious side effects. In 2004, about 423,000 adverse events were collected by the FDA, even though drug reactions account for nearly 700,000 emergency room visits each year.
Drug makers are required to report adverse events to the FDA, yet doctors and patients -- those with the most direct experience with side effects -- voluntarily report them, and little is done by the FDA to make consumers aware of how to report side effects.
An Institute of Medicine report found that in 2004, only 21,500 of the more than 422,000 reports that year came from doctors and patients.
The Consumer Reports survey asked consumers if they would know where to report a serious side effect -- 72 percent said they would. Among them, the vast majority (79 percent) said they would report their problems to their doctor, followed by their pharmacist at 16 percent. Only 7 percent of that group said they would file a report with the FDA.
"Doctors and health care professionals play an important role in drug safety when they report their patients' adverse reactions to the FDA. But we're aware of the demands on their time, and we think consumers should know there is a resource available at the FDA to track their severe drug reactions," Foley said.
|SOURCE Consumers Union|
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