Talk to the FDA
Posted on April 2nd, 2008 – 11:58 AMBy Josephine Marcotty
Did you know that you, the consumer, can report a bad drug reaction directly to the Food and Drug Administration? It’s a little known fact that Consumers Union and Kim Witczak think should be advertised alongside each and every TV ad for the drugs that could cause them.
Consumers Union is the national consumer advocacy group that publishes Consumer Reports. Kim Witzcak, who just happened to be sitting in an office at Consumers Union when I called there today, is a south Minneapolitan who came up with the idea of advertising the reporting system directly to consumers.
She said she wishes she’d known that such a reporting system existed five years ago when her husband, Woody, committed suicide in their garage. She’s always been as certain as only a wife can be that it was the drug, Zoloft, that caused him to take his own life.
After his death Witczak became a passionate and articulate advocate for the black box warning about the increased risk for suicide that is now required on all of the antidepressants known as SSRIs. She also launched a drug safety advocacy group called WoodyMatters. Which is what brought her to Consumers Union.
Last fall, congress passed a law requiring print drug ads to include a phone number and web address that patients can use to report adverse events to the FDA. But their use on the far more influential TV ads will only be studied.
“It’s a stall tactic in my mind,” Witczak said. Consumers Union is pushing the FDA to enact the TV ad requirement now.
Collecting drug reaction reports from consumers is the fastest way to signal a drug safety problem, it says. But at the moment few people even know that such a reporting system exists. It’s called MedWatch. In 2004 it collected about 423,000 adverse reports. But nearly 700,000 people a year end up in an emergency room because of a drug reaction, Consumer Union says. “This is so simple,” Witczak .”It takes advantage of what the FDA has in place.”
You can also call MedWatch at 1-888-INFO-FDA (1-888-463-6332)
One response to "Talk to the FDA"
There is no doubt that this information should be more readily available to the general public. However, more and more we are seeing that consumers need to become their own advocates. New drugs can’t possibly be tested on everyone before they’re approved by the FDA, and there are so many new drugs out there for any one physician or pharmacist to keep up with. Don’t trust anyone when they tell you a drug is completely safe and free of side effects, and always read the information you receive from the pharmacist!
