The U.S. Food and Drug Administration (FDA) has issued urgent safety letters to the medical professional community and public concerning a drug used to treat gout, an arthritic condition characterized by an increase in uric acid in the blood.

The medicine, Uloric, has been found through a follow-up post-market clinical trial to increase the risk of non-deadly Uloric stroke, heart attacks, and cardiac ischemia.

The trial also underscored the possibility of Uloric contributing to a higher risk of deadly cardiac events and sudden death from numerous causes.

The clinical study was performed by Takeda Pharmaceuticals, makers of Uloric. The study involved over 6,000 patients diagnosed with the condition of gout. Half of the gout sufferers in the study took allopurinol and the other half took Uloric. The aim was to compare the relative health risks as they appeared in both groups to each other.

In pre-market clinical trials, the higher risk of Uloric stroke, heart attack, and other cardiac-related death was revealed and sparked the request by the FDA to request this subsequent test. There has been a warning on the label of these risks since its approval in 2009.

The most recent testing produced similar results when comparing the performance of allopurinol and Uloric–a higher risk of non-deadly Uloric stroke, heart attack, and cardiac ischemia requiring quick surgical intervention.

The study results also pointed to additional risks while taking Uloric of a more final nature—sudden cardiac death from heart attack or non-specific causes.

The two safety letters recently released by the FDA in response to these results state the agency will continue to look into heart-related and other conditions possibly linked to the gout medication. The letters from the FDA also stated that they intend to look into the non-deadly adverse medical events like Uloric stroke and cardiac arrest during treatment.

Former Whistleblower Case Alleged Inadequate Disclosure of Risks

The full disclosure by Takeda Pharmaceuticals of increased risks of non-deadly Uloric stroke, heart attacks, and sudden death while taking the gout medication is expected when any post-market clinical study is requested by the FDA.

In a 2012 whistleblower lawsuit, Takeda was accused by a safety consultant who used to work for them of failing to reveal dangerous side effects of the medication when used in combination with other prescriptions such as digoxin, imuran, methadone, and warfarin.

The lack of transparency with these adverse side effects allegedly contributed to the demise of several drug recipients.

Takeda was also accused of withholding key information by not reporting instances of purported bone marrow problems, kidney problems, and uncontrolled bleeding during treatment with Uloric. The plaintiff alleged that the pharmaceutical company falsified key documents released to the FDA rather than reveal this information.

The whistleblower alleged Takeda was in violation of the False Claims Act (FCA). In supposedly falsifying these documents, the company was able to keep Medicare and Medicaid patients on Uloric, which cost 50 times as much as allopurinol.

Current FDA Recommendations

In the light of these most recent clinical study outcomes, the FDA recommends that patients currently taking Uloric make an appointment to discuss their treatment with their prescribing physician if they have any questions or concerns.

They do not recommend anybody stop taking their medication without the involvement of medical professionals. Doctors and nurse practitioners should evaluate the health status of those whom they have placed on this medication.