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Reporting Drug Side Effects
If it were you, your kids or other family members that had dangerous side effects due to prescription drugs... wouldn't you want to know?
FDA commissioner wants to study the idea for two more years
In 1997, the federal government eased the rules on advertising on TV and radio, allowing prescription drug companies to shorten the warnings on side effects in commercials. Now, the FDA is currently debating whether to require a 1-800 toll-free number and web address on all TV drug ads, so consumers can report serious drug side effects to the
FDA. This is already required in print drug ads. So this decision would put it on TV ads and web address, where more consumers would see it.
Factors that require consideration
Because television is a different medium from print, the best way to put a toll-free number on television ads needs to be studied. Among the factors that require consideration are the best place to put the number and how long it should stay on the screen.
Consumers need to know
It's important that consumers have a way to report adverse side effects. Some of the time, drugs are only tested on a very small number of people, and it's not until the drug is on the market that we start to see serious side effects, that's when the real test happens. People have the right to know all possible side effects of drugs they are taking, or that may be prescribed for them. Providing a toll-free number and web address on all TV drug ads are a necessary part of consumer protection. The FDA does have a method for consumers to report adverse side effects from prescription drugs. However, most people who report serious side effects report them to their doctor; only 7 percent report them to the FDA. Better reporting of side effects will help the FDA do a better job of detecting dangerous prescription drugs on the market sooner. Dangers often emerge only after millions of people start taking a drug. Please take a minute to sign a prepared form letter to the FDA today. Let's make reporting these side effects to the FDA easier.
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Contributor's Note
Here's comments from the petition site:
As a registered nurse and a consumer who had a serious side effect to levofloxacin (tendonitis) and could not get my doctor to report it, I am in full support of being able to report my side effects to the FDA directly. The failure to act on this matter in a timely manner will constitute not only a lack of leadership by the FDA but also an abandonment of your duties as required by law to protect the public and promote the public health. In short, it will be a disgraceful display of ineptness by a federal agency charged with a very important responsibility. The time to act is NOW!!!
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Prepared Form Letter
Drug Side Effects Ads
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This intel was contributed by health
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May, 2012
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