Diabetes drug had been recalled in 2000 due to its link to liver failure. FDA was forced to do so as reports of its being associated with liver failure in patients using it, poured in.

Rezulin is an oral anti hyperglycemic drug. It contains Troglitazone as its main active ingredient. Rezulin is used for management of type II diabetes or Diabetes mellitus. It is non-insulin dependant type of diabetes. Rezulin decreases insulin resistance. It makes muscles and adipose tissues more responsive to insulin. It helps to improve body respond to insulin. It controls blood sugar level by reducing sugar produced in liver. Troglitazone has been withdrawn from the U.S. market in 2000.

Liver failure was so evidently prevalent amongst patients using Rezulin, that it could not be ignored. Patients using this drug were regularly being monitored for any liver damage. Its use not only lead to liver damages, but was capable of fatally worsen the existing liver problems. It was said that patients using this drug were at 1200 time higher risk to have a liver failure than non-users of the drug.

Many of the patients using this drug suffered jaundice, fatigue, abdominal pain, weight loss, nausea and vomiting, loss of appetite, back pain and dark urine, which are symptoms of acute liver damage. It had caused liver failure in many patients. They needed to have a liver transplant. It is also said to cause coma and even death in some patients. It is also linked with heart problems.

After issuing many safety alerts related to this drug time to time FDA finally decided to withdraw it from the market on 21st March 2000. It asked the manufacturer of Rezulin, Parke-Davis/Warner-Lambert to withdraw this drug from the market. Parke-Davis/Warner-Lambert agreed to do so.

This action was a result of safety review of Rezulin and two other similar drugs rosiglitazone (Avandia) and pioglitazone (Actos), by FDA. FDA came to a conclusion that these drugs have similar benefits to Rezulin but bore lesser risks. These two drugs were also related to severe side effects later.

FDA came to a conclusion that Rezulin was not a safe drug and patients using this drug were at a continual hazard of developing severe health problems including liver or heart failure. It stated that Rezulin posed an unacceptable risk to patients.

Reports of liver toxity due to side effect of Rezulin use had been coming since 1997. FDA several times asked the drug manufacturer to update the safety label. Parke-Davis has strengthened the drug’s label many times as asked by FDA. It also asked for a regular and close monitoring of liver functions in patients using Rezulin. But cases of liver failure due to Rezulin did not stop.

FDA’s Endocrine and Metabolic Drugs Advisory Committee reviewed its risk in March 1999. They recommended that this medicine should be available to only a selected group of patients, whose diabetic condition was not controllable by other drugs. FDA continued a close review of risks associated with use of Rezulin. Finally it decided a recall.

FDA asked patients who had been using Rezulin to contact their doctor and opt for an alternative treatment option as use of Rezulin was a threat for their health.