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Should You Worry About Drug Side Effects?

Fast Talk Can Make Cure Seem Worse Than Condition

POSTED: Friday, May 9, 2008

You know that muttering you hear at the end of a drug commercial?

Common side effects include headache, nausea, stomach pain or sore throat. May cause increased gambling urges. Customer may not have full control of their bowels at all times.


Industry Targets Side Effects

Listening to that could make you wonder if the disease the drug is fighting can possibly be worse than the side effects. But anticipating and managing side effects can be a patient's best way to protect their health.

About Those Ads?

The Food and Drug Administration released guidelines in 1997 that allowed drug companies to greatly expand the scope of their direct-to-consumer advertising as long as they ?present a fair balance between information about effectiveness and information about risk.? A University of Georgia study released in January found that about 15 percent of an average drug's total ad time is spent listing side effects. And the side effects you hear about on TV may not even be the half of it, pharmacists said.

That means the makers may not know enough about a problem to mention it.

Tracking After Drug Hits Shelves

"Most adverse events of new drugs are reported within two to four years," said Keith M. Olsen, the chair of the Department of Pharmacy Practice at the University of Nebraska Medical Center. "It's very difficult to pick up an adverse event that occurs in (less) than 1 in 10,000 patients. It's very, very difficult to determine in a clinical trial."

That means that all of the side effects aren't yet known when the first commercials go to air for a new drug. What's worse, Olsen said, is that the FDA has had no formalized process to track problems once the drug is approved. It mostly relies on voluntary reports from consumers and pharmacists.

Olsen said that on the pharmacy side, that reporting can be daunting.

"You have to fill out a form and describe the adverse event. We did a study in our (intensive care unit) once of an antibiotic and found it produced these abnormal heart electrical tracings. The company asked us to submit forms and we had so many patients we couldn't do it," Olsen said.

That is changing. In February, the FDA sent out a staff memo introducing "Safety First." An FDA spokesman said the initiative will strengthen oversight of prescription drugs after they are approved and build a new database of medications' possible harmful side effects. It will also set up timelines for following up on those concerns.

You Can Protect You

In the meantime, pharmacists said, a patient's best protection is information. Ask questions of both your pharmacist and physician, reach out to reputable online resources for more and read the pamphlet included with the drug.

Shaun and Janice Schleif's doctor had been asking them to quit smoking for years and recently recommended Chantix. Chantix has made headlines recently for side effects that include insomnia and nightmares.

"Quitting smoking alone has its own long list of side effects," Shaun Schleif said.

The Schleifs had tried patches and gums with no luck, so they read the drug's pamphlet and surfed the 'Net before they decided to give Chantix a try. At least they knew what to expect.

"When we do sleep we have vivid dreams," Shaun Schleif said.

Tamping Down Anxiety

At a San Diego Wal-Mart, pharmacy manager Laura Evans said every customer is offered counseling every time they pick up a prescription, whether it is old or new. She said she spends a lot of that time tamping down customer anxiety about the side effects they've heard about on TV.

"People see people talking fast, listing horrible things. (The companies are) required to report everything, even if it was one person out of thousands," Evans said. "We calm a lot of fears with stuff like that. You don't want to scare people. I usually say, 'This is rare, but if you do experience it, tell me or tell your doctor.'"

Olsen said patients need to get information about how to look for side effects happening in their bodies.

"The patient has to be aware of abnormal things that can happen -- especially with eyesight, dizziness, cognitive function," Olsen said, warning that drugs that carry those side effects could turn fatal if someone experiences them behind the wheel. "(Also,) be aware of gastrointestinal adverse effects -- not just nausea or diarrhea, but urine color and stool color."

Patients who didn?t get all of the details at the clinic should barrage the pharmacist for answers, Evans said.

"The doctors, a lot of times, won't fully go over everything. We have a little more knowledge. Many people may not take as good of advantage of having us available as they should -- even with over-the-counter stuff. People should take advantage," Evans said.

In addition to side effects, a pharmacist can analyze possible prescription and over-the-counter drug interactions. That's why both Evans and Olsen said using a single pharmacy is paramount for drug safety.

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