How do I contact the FDA about dangerous drug side effects? - KLTV.com-Tyler, Longview, Jacksonville, Texas | ETX News

How do I contact the FDA about dangerous drug side effects?

Updated: Aug 26, 2011 03:17 PM EDT
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By Elaine Zimmermann

Rita: My husband fell and injured his hip. After leaving the hospital, he told his doctor he was worried his confusion may have contributed to his fall. The doctor told him that his incontinence medicine may be contributing to his confusion. He went off the medicine and three weeks later he was no longer confused. Should I contact a lawyer?

Elaine: I contacted a law office and they suggested you first contact the Federal Food and Drug Administration (FDA) to file a complaint about the drug.

I contacted the FDA to learn more about the process for our readers. This is a portion of the response I received:

"We are very sorry to learn about your experience with the drug you identified. Confusion was not listed as an adverse event with the original approval for this drug. However, during post-marketing surveillance after its approval, confusion was reported and listed in the post-marketing experience. You may find this information on the DailyMed (portion of the FDA) website."

After examining the link they sent me, I found not only confusion was reported and listed in the post-marketing experience, but hallucinations were also reported. I contacted the officer in charge of the FDA to understand how such serious side effects could have been missed in the product testing. She explained, "Many drug trials are not done on seniors but rather people in their 40's and 50's. Seniors can have side effects not experienced by this population."

I asked how these side effects, now known, were not required to be in the national advertising disclaimers. She explained that at the time of the drug's approval these side effects were not known and the advertising disclaimers were based on those known side effects. She urged consumers to report their experiences on the FDA's MedWatch program. "We view this reporting system as a source for signaling trends. Should a trend emerge, the FDA will work with the sponsor of the product to address the problem. Actions may include changes in the labeling information… In the most serious cases, the drug may be recalled."

The law firm representative said that once the FDA requires a drug maker to make labeling information changes or recalls a product, then consumers who have experienced injuries or other adverse effects of the drug may wish to wish to obtain legal representation. Many times, in a lawsuit against a drug manufacturer, these individual cases are combined into one larger class action -- which consist of a group of individuals that have suffered a common injury or injuries. Typically these cases result from an action on the part of a business or a particular product defect or policy that applied to all proposed class members.  

If a drug can be shown to have caused elderly persons to fall and be injured or die, a class action could be warranted. Action by the FDA against the drug manufacturer would give credence to such a claim.

Elaine Zimmermann is a personal finance expert who was written about everyday ways to save money on cars, homes, vacations and more. For information on investing in foreclosed real estate you can visit her website at www.AskElaineZ.com.

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