In 1988, the FDA created a system to quickly move potentially life-saving drugs through the approval system. Their idea was to help consumers get drugs that could help treat serious diseases, especially those during the HIV crisis of the 80s quickly. However, pharmaceutical companies have been abusing this loophole for decades with devastating results.
About the FDA’s Fast Track Drug System
When a pharmaceutical company wants to fast track their drug, they need to first apply and complete an investigational new drug application. Within 60 days, the FDA approves or denies it. After the FDA approves the drug for the fast-track process, the company must conduct trials and submit data. Most of the time, there is only a single study conducted.
Fast Track Drug System is Deadly
In the last 5 years, nearly 57% fast-track drugs received a black box warning. Researchers found that a growing number of drugs approved through the fast track process have serious side effects. The FDA had to remove many from the market.
Xarelto & Praxbind were Fast Tracked
Xarelto, one of the next generation blood thinners was pushed through the FDA approval process to prevent strokes in heart patients. Janssen, the manufacturer conducted the only study completed to the efficacy of Xarelto. If the FDA did not fast track the drug, they may have noticed the entire study used faulty blood testing devices. It took almost 5 years after approval for the FDA to issue a report. During that time thousands have been injured or died from Xarelto’s uncontrollable bleeding.
Pradaxa, another blood thinner with catastrophic results recently had its reversal agent approved by the FDA. The FDA and Pradaxa manufacturer, Boehringer Ingelheim are scrambling to rectify their huge mistake when the FDA fast tracked Pradaxa. Faulty studies and negligent marketing labeled Pradaxa as the safest and most effective blood thinner on the market. Now, nearly 6 years later and after 9,000 patient hospitalizations and over 1,000 reported deaths, a reversal agent, Praxbind, is finally released to help mitigate the devastating effects caused by Pradaxa.
Praxbind Not Effective
Right now, Pradaxa has the only antidote, Praxbind to stop a bleeding event. However, it isn’t nearly as effective as manufacturers want you to believe. In a case study, a 65-year-old man received the antidote. Coagulation tests improved, but the man remained unstable. An upper endoscopy revealed he was still hemorrhaging. Several attempts to control the bleeding failed, and he needed surgery. His dose cost over $3,000!
Bottom line, there is no real proof that Praxbind is effective. It improves lab results, but when a person experiences a truly life-threatening bleeding event, it may not stop it. So, once again this fast-tracked drug is causing more harm than good.
If You were Harmed by a Fast Tracked Drug
If you experienced uncontrollable bleeding from taking the fast tracked drugs of Xarelto or Pradaxa, you need an experienced law firm to take your case.
Michael Brady Lynch, the founder of The Michael Brady Lynch Firm, was a member of the Plaintiff’s Steering Committee in the Pradaxa Multi-District Litigation and instrumental in securing the $650 million settlement for those injured by Pradaxa’s uncontrollable bleeding. Mr. Lynch continues to be a leader in Pradaxa litigation nationwide in representing those who continue to suffer uncontrollable bleeding events from Pradaxa.
The Michael Brady Lynch Firm is your blood thinner lawsuit law firm. We can help recover medical expenses, lost wages, and other damages. Contact us today for a free, no obligation case review.