Gout medication Uloric has recently been linked to heart-related fatalities in a study, and the Food and Drug Administration has updated a warning regarding Uloric heart risks. The study identified that when Uloric was compared with other medication, Allopurinol, the Uloric heart risks were much higher, including death.

Outside of Uloric heart risks, other serious side effects were recorded in that study, including non-deadly strokes, cardiac ischemia, and non-deadly heart attacks.

Uloric’s manufacturer, Takeda, has a U.S. subsidiary that is based in the Chicago area. Gout patients across the country may have been subjected to Uloric heart risks without being appropriately warned of the side effects.

Drugs and Pre-Market Testing

Before releasing a drug onto the market, drug manufacturers must complete rigorous research and testing. However, if that testing isn’t done properly or if the results appear skewed, doctors and patients may assume a medication is safer than it really is. Only when patients come forward to file complaints and reports does it often become apparent that the drug is dangerous.

Although all medications will carry some risk of side effects, it’s the responsibility of the manufacturer to limit those where possible and to inform patients about the dangers with appropriate warnings. When injured patients can show that the risk should have been or was evident to the maker and that these details never made it to the marketing materials or the label, the manufacturer could be held accountable for injuries sustained.

A clinical trial indicated that Uloric had a much higher risk of heart-related incidents and death when compared to similar medications. More than 6,000 patients were included in that study.  Those initial clinical trials did indicate a higher risk of heart-related deaths, strokes and heart attacks and those risks were outlined on the drug’s initial marketing materials.

Uloric was initially approved in 2009 by the FDA. However, the FDA indicated that Takeda would need to complete additional studies because of Uloric heart risks and other dangerous side effects; the manufacturer undertook additional clinical trials after the first release of the drug.

In 2012, a safety consultant brought forward a whistleblower lawsuit associated with Uloric heart risks and other adverse side effects that could negatively affect patients. The plaintiff alleged that Uloric heart risks and other dangerous side effects were known by the manufacturer but were not shared with the medical community or prospective patients.

Some of the side effects reported in addition to Uloric heart risks included concerns over kidney failure, bone marrow failure, severe bleeding and interaction problems with Methadone, Warfarin and other medications.

According to more patients coming forward to report Uloric heart risks, the failure to report this information may have even led to the death of some patients. Many of the patients who already experienced severe side effects while taking the drug are considering legal action to protect themselves. If you or someone you know in Chicago or elsewhere was harmed as a result of the severe side effects of Uloric, you may be able to participate in a class action lawsuit investigation.