Xarelto Studies and FDA Warnings
Xarelto FDA Warning
Before a pharmaceutical manufacturer can sell a medication on the market, it must put the product through extensive clinical trials and testing. Once this gets done, the manufacturer can apply to market their product with the U.S. Food and Drug Administration (FDA). On average, it takes years and millions of dollars in research for a medication to go from the drawing board to the pharmacy shelves. Even with such rigorous testing and clinical trials, some medications approved by the FDA are later found to have serious, hidden side effects.
If you have suffered adverse side effects or lost a loved due to the use of an FDA approved drug, it is vital that you consult a pharmaceutical litigation attorney.
Farah & Farah is currently investigating dangerous drug cases nationwide. Let us put our skills to work on your case. We can help you get the settlement you deserve.
The Journey to FDA Approval
It is estimated that only one in 1,000 compounds developed in a pharmaceutical company’s laboratory will ever be tested on a human being. Once the FDA approves a drug’s application, the medication is then considered an "investigative drug." It will then enter three phases of clinical trials.
- Phase one: The drug is tested on 20 to 80 healthy volunteers. Phase one generally takes about one year.
- Phase two: The drug is tested on a larger group of 100 to 300 healthy volunteers. This takes about two years.
- Phase three: The drug is administered to 1,000 to 3,000 patients at clinics and hospitals where results are closely monitored. This takes approximately three years.
Once the testing is complete, the manufacturer can submit the test results to the FDA for approval. Once approved, physicians can prescribe the drug.
The Flawed FDA System
While this testing process seems thorough, critics of this system point out that the majority of the testing is carried out under the exclusive direction and control of the drug’s manufacturer itself. The FDA doesn't conduct scientific testing, it bases approval on results the manufacturer provides.
The Negligence of Xarelto
All anticoagulants have been known to cause uncontrolled bleeding. Xarelto is so much more dangerous because there's no known way to stop the bleeding. Coumadin, one of the other most commonly prescribed blood thinners, has also been known to cause uncontrolled bleeding. But, the bleeding caused by Coumadin-thinned blood can be stopped by taking vitamin K. Johnson & Johnson, the maker of Xarelto, is a large pharmaceutical company that knew the danger of uncontrolled bleeding tied to Xarelto. Their actions are negligent and they need to be held accountable.
Take the Following Precautions if You Use Xarelto
Physicians recommend the following precautions for people taking Xarelto:
- Inform your doctor if you are pregnant or breastfeeding, have an artificial heart valve, have kidney and/of liver disease, or have bleeding problems.
- Avoid rough sports and situations that may cause bruising.
- Take extra care when using sharp objects.
- Brush and floss your teeth gently.
- Blow your nose gently.
- Inform every doctor or dentist who treats you that you are taking Xarelto.
Even if you heed the warnings of the FDA and knowledgeable physicians, harmful side effects can still occur when taking Xarelto. If you or a family member has suffered an adverse side effect while using this medication, it is important that you contact a pharmaceutical litigation attorney.
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If you’ve been injured by Xarelto, contact Farah & Farah today and tell us your story!