Call the attorneys at PW immediately if you have suffered any of the following conditions after taking Uloric, as there may be time limits for you to file a claim:
- Gout flare-ups,
- Liver problems, including liver enzyme abnormalities,
- Severe skin reactions, like Stevens-Johnson Syndrome,
- Heart attacks,
- A diminished flow of blood to the heart, also known as unstable angina,
- Strokes, and
- Cardiovascular death.
The risk of cardiovascular problems was known to the U.S. Food and Drug Administration (FDA) very early on. When the FDA was considering Takeda Pharmaceutical's request to approve Uloric for use in the U.S. in 2009, it expressed concern with the likelihood that Uloric could cause heart problems. The FDA refused to approve the dose levels that the Takeda Pharmaceutical Company had requested. Takeda had wanted Uloric to be approved in 80 and 120-milligram doses. However, the FDA would only approve doses of 40 and 80 milligrams because of the possibility that the drug could cause heart problems in larger doses.
The FDA included a warning on Uloric's marketing label that mentioned the possibility for Uloric to cause cardiovascular problems.
Finally, the FDA required Takeda to conduct a postmarket clinical trial to test whether Uloric carried a risk of cardiovascular problems for people who took it to treat their gout.
This clinical trial was supposed to begin on January 31, 2010, and be submitted to the FDA five years later. However, the results were not released until June 14, 2018, only a short time before Takeda's patent protection for Uloric in the U.S. was set to expire.
The clinical trial, called the CARES trial, was both randomized and double-blind, but contained no control group taking a placebo pill. Instead, it tracked 6,198 people in the U.S. and Canada who were either taking Uloric or Zyloprim - the older gout medication that was first sold in 1966 - for their gout. Over the course of several years, the CARES trial would monitor the participants for cardiovascular events.
The FDA has updated Uloric's warning label. The new warning label for Uloric included a box warning that prominently warned doctors and patients about the risks of developing a potentially fatal heart condition from taking Uloric.
You may be entitled to compensation from Takeda for the following:
- Medical bills paid for treatment
- Anticipated medical expenses in the future
- Lost wages
- Reduced ability to earn a living
- Costs of home modifications made necessary by mobility problems caused by Uloric
- Physical pain and mental suffering
Call the lawyers at PW today at 954-462-6700 for a free evaluation of your claim.
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