11222017Headline:

Rockford & Moline, Illinois

HomeIllinoisRockford & Moline

Email Nick Avgerinos Nick Avgerinos on LinkedIn Nick Avgerinos on Twitter Nick Avgerinos on Facebook
Nick Avgerinos
Nick Avgerinos
Contributor •

Prognosis Not Good: Slippery Slope of Safety and FDA Approval

Comments Off

With our incredible research capabilities, the availability of prescription drugs designed for your ailment can be daunting. And most of us want to know exactly what it is we’re putting into our bodies by taking that pill. An FDA approval acts as a safety blanket, something to quiet those doubts about filling a prescription.

For those of us who are that cautious, who avoid the ominous online world of fast pharmaceuticals, and do our own research regarding benefits and side effects, that seal of approval from the FDA is an affirming nod from those who know better. It’s disconcerting to learn, then, that “FDA approved” doesn’t mean a whole lot…at least not anymore.

You should know that recent litigation has whisked away your safety blanket and revealed the scary state of pharmaceuticals underneath. Nothing guarantees that what you’re taking is safe. Nothing. Recent high court cases are emphasizing just that, allowing pharmaceutical companies (and the FDA) to escape liability when those “FDA approved” drugs are discovered to be dangerous.

On May 28, for example, two separate state appellate courts largely dismissed claims regarding the painkiller Vioxx. Merck withdrew Vioxx from the market in 2004 after research demonstrated that the drug was linked to increased risk of heart attack. Effectually, the courts said “that’s too bad.” But words ring hollow for those whose lives are jeopardized by such risks.

As Forbes noted, this is good news for medical device makers. Unfortunately, it’s bad news for the rest of us. A case set to go before the Supreme Court this fall, Wyeth v. Levine, will have a big role in shaping your rights with regard to pharmaceutical products. A ruling for Wyeth would preempt product liability lawsuits when a drug has been approved by the FDA, even when the drug is subsequently found to be harmful. Such a ruling would likely lead to further curtailing of your rights, as other industries would try to mimic this preemption doctrine.

When asked what its own approval means, the FDA responds as follows:

“No drug product is ‘perfectly’ safe. Every single drug that affects the body will have some side effects. Since the FDA considers both the benefits and risks of all medications before approval, side effects are generally not serious. For every drug FDA approves, the benefits are balanced against its risks. In addition, FDA makes sure the labeling (package insert) outlines the benefits and risks reported in the tested population. You and your health-care provider should decide together if the benefits outweigh the risks for YOU. Talking about your medicines with your health-care provider is just as important and good for your health as a complete check-up and taking your medicine as directed.”

In other words, talk to your doctor. Do your own research. And it’s a good idea to keep an eye on current legal decisions. Knowing your health and your rights is primarily your own responsibility. And if the current of the Supreme Court keeps trending the same way, you might be the only one left to take responsibility. So, please, be responsible.