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FDA concerned about your medications

Safety concerns for your RX and over the counter medicine

If you're like a lot of Americans, you probably take some medications everyday. There could be serious side effects to them you're not aware of -- even if you've been taking them for years. One out of three drugs have been found to have safety concerns. Especially newer drugs and those that are accelerated through the FDA process.

It was years ago when "Will Zinninger" began a new cholesterol medication. Then something unexpected happened to him.

"My muscles began to be real real sore. I called my doctor."

Will's doctor ordered him to stop taking the medication immediately. He says he never took it again.

The surprise side effect from his FDA approved medication is something pharmacists say is a normal part of the FDA's drug marketing process. While unexpected stiffness, sore muscles, dizziness, heart palpitations or any number of other side effects may be shocking to patients who thought their drugs had been tested for all possible outcomes, newly occurring side effects are nothing new for pharmacists.

Dr. John Arnold, a pharmacy professor at Samford University, says he's not surprised at all.

"When we initially test, we test on a small amt of patients. And when a drug is marketed, it goes to a wide range of patients."

Take Will Zinninger's cholesterol medication for example. If the pharmaceutical company tested only 1000 people, and found no significant reports of muscle aches, that complaint may not become apparent until the drug is distributed to the masses.

"If the FDA starts seeing reports from numbers of people, then the FDA goes out and investigates." Depending on the severity of the side affects, the FDA will either release new warnings or pull the drug out of the market altogether.

It takes about fifteen years between pharmaceutical companies testing their drugs and submitting their data to the FDA for approval. The FDA takes 200 days to examine those findings before approving medicine for public use. Dr. Arnold says the FDA has a tough job approving drugs for public use. They must balance between extensive safety examination -- and getting critical medicines to patients who need them as quickly as possible.

"Either way they go, they're gonna get criticism," says Dr. Arnold. "If they say 'We're gonna test drug for fifty years, they're are probably lots of people who need the drug who may not have access to that drug."

And, that's a concern Will Zinninger may not have again. He now tries to maintain his health without any medication.

Pharmacists say it is very important to pay attention to your body when you begin a new medication. Report any unexpected side effects to your doctor or directly to the FDA immediately. The FDA has a reporting feature on its website called Medwatch.

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