Warfarin (also known as the brand names Coumadin, Jantoven and Mareva) is a blood thinner used to prevent thrombosis and thromboembolism, which are both caused by blood clots.
Many common foods and medications can interact badly with Warfarin, like leafy greens and vitamin K. Patients using Warfarin must undergo blood testing to rule out the risk of excessive bleeding.
In May 2014, the FDA wrote a letter to Sun Pharmaceuticals, warning the company about one of its foreign manufacturers. Inspectors had discovered that the staff had been hiding batch failures, conducting unofficial testing and deleting files.
The letter told Sun that there was a “general lack of reliability and accuracy in the data generated by [the] firm’s laboratory… that raises concerns about the integrity of all data generated by your firm.” This will be Sun’s third medical recall this year.
Sun recalled antidepressant Venlafaxine Hydrochloride back in July for failed dissolution tests. Antibacterial drug Cephalexin followed quickly, after the FDA uncovered substandard manufacturing processes.
Why Was My Drug Recalled?
Warfarin can have dangerous side effects, even in its standard dose. Overdoses of the drug can cause excessive bleeding risks, so the drug must be in its proper concentration to be safe and effective.
Sun Pharmaceuticals is quickly developing a reputation for inaccurate data reporting and unsafe manufacturing. When pharmaceutical companies cut corners, it is the patients who suffer.
Patients need to be protected from negligent drug companies. For more information about how our pharmaceutical litigation attorneys could help you, contact Proffitt & Cox, or follow the law firm on Facebook or Twitter.
Proffitt & Cox, LLP – Columbia Injury Lawyer