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Almost a Third of FDA-Approved Medications Have Safety Risks

Marking one of the most disturbing trends of our time, a recent study has shown that nearly one-third of the drugs the Food and Drug Administration approve show safety risks after they are released into the market.

It’s not surprising that the multi-year analysis, published in the Journal of the American Medical Association, has garnered vast attention by major news outlets.

The study looked at more than 220 “therapeutic” products approved by the FDA from 2001 to 2010. The findings may be astounding to the average American: 32% of all the medications reviewed required some FDA action after approval to warn medical professionals and consumers of previously undiscovered risks.

Typical FDA actions could include a full retraction of the drug from the marketplace, a change to the medication’s physical label to denote additional dangers or a public safety communication about hazardous side effects. But, according to the study, guess how long on average it took the FDA to warn unsuspecting people? More than four years.

So why is this happening? How is the FDA allowing suspect drugs to sneak through the system? Are some medications getting fast-tracked to market? There are a number of factors that could be leading to an unsettling number of potentially dangerous medications available to consumers.

To earn FDA approval a medication must be deemed safe and effective. It’s possible that new-drug clinical trials may not be including enough patients to truly demonstrate widespread effectiveness for future users—or enough follow-up time to account for possible side effects over the long term.

The study pinpointed a few drugs that seemed particularly susceptible to the post-market safety events requiring FDA action: “… biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval, and those with near–regulatory deadline approval,” according to the abstract.

While it’s impossible to deem all drugs completely safe, the FDA has a critical responsibility to protect the health of the country to the best of its ability. When that doesn’t happen it leads to the backlash we’re seeing every day in this country: people suing drug manufacturers and rule-makers for negligence.

If this information is concerning and you or someone you know has taken a medication that has been subject to a safety recall, label modification or public communication, the defective drug lawyers at Whitley Law Firm want to hear from you.

If the FDA isn’t going to protect you, we will. As a longstanding law firm, it’s our duty to help you protect your individual rights. Call us today with questions about your FDA-approved medication or ongoing class-action lawsuits related to the growing list of dangerous medications.