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FDA Testing Proposed Simpler Prescription Drug Labels to Fight Overdoses and Misuse

By April 28, 2011July 16th, 2019Drug Safety

As a dangerous prescription drug attorney, part of my job revolves around the effectiveness of warning labels on pharmaceutical products. So I was interested to see a recent article about a push by the U.S. Food and Drug Administration to make prescription warning labels easier to understand. The Wall Street Journal reported April 25 on a pilot program from the FDA that would replace the several-page inserts that come with prescription drugs with a simple one-page sheet. And an FDA-affiliated organization, the U.S. Pharmacopeial Convention, is developing a proposed national standard for the warning labels on the bottles themselves, which would state the purpose of the drug clearly and include simple instructions. Doctors and pharmacists are also encouraged to counsel patients more effectively, as part of a national campaign for awareness of the need to use drugs as directed.
Research shows that some patients really do need help with this. Three out of four Americans told the National Community Pharmacists Association that they don’t always use drugs as directed. One Northwestern University professor told the Journal that more than half of adults in several recent studies misunderstood packaging directions. Those mistakes can come at a price: the federal Agency for Healthcare Research and Quality found that 1.9 million Americans were hospitalized for medication mistakes between 2004 and 2008, a with 52 percent jump in hospitalizations over those four years. The professor said some instructions on prescription labels are contradictory or genuinely confusing. Trouble also arises for patients with multiple chronic conditions, which makes medication errors more likely, and people with low literacy.
Prescription and over-the-counter warning labels are an important part of drug safety. And as a pharmaceutical liability lawyer, I know they’re an important part of recovering financial compensation when you’re hurt by a dangerous prescription drug. That’s because showing that you followed the directions on the warning label is a necessary part of showing the drug caused your injuries. Under the law, you often cannot recover financial compensation if the drug company can show that you disregarded the warning label. By contrast, the pharmaceutical company has legal obligations to warn you about the potential dangers of using the drug — and failure to warn is the basis for most pharmaceutical lawsuits. Most importantly of all, easily understood warning labels have the potential to stop millions of people from becoming ill because of medication mistakes.

If you believe you were sickened or injured by a medication you thought you could trust, you should talk to Carey, Danis & Lowe right away. From offices in St. Louis and Belleville, Ill., we represent people from around the United States who were seriously hurt or lost a loved one because of a defective over-the-counter or prescription drug. Americans trust the FDA and other federal agencies to make sure that nothing is for sale in the United States that’s unreasonably safe. Unfortunately, it’s just not safe to make that assumption, as a series of recent high-profile drug lawsuits has shown up. Our defective prescription drug attorneys help clients hold pharmaceutical companies responsible for their actions — singly or as part of a class action — and recover the money they need to get medical care, make ends meet and be fairly compensated for their losses.
Carey, Danis & Lowe offers free, confidential case evaluations, so you can talk to us about your case at no further risk or obligation. To learn more or tell us your story, call us today at 1-877-678-3400 or send us a message online.