Rezulin Diabetes Drug Label

Rezulin diabetes drug was the first of the thiazolidinediones or glitazones that help to boost the effects of insulin.  The FDA has sped up their approval methods due to the increase in congressional pressure, and there are more and more drugs that are being approved on the “fast track” when considered to be a breakthrough in medicine.  The average review time for new drugs was down 34.3 months in 2000 from 1993, making the average FDA review time just 14.6 months. 

Rezulin diabetes drug was approved in just six months despite the serious concerns raised well before the drug’s approval.  During the time Rezulin was on the FDA method of requiring label changes have been widely criticized due to the inefficiency of change it creates. 

According to a Duke University Clinical Research cardiologist, Robert Califf, at an FDA advisory committee meeting, less than 1% of physicians have even seen a label in the last year (1999).  A health policy man at George Washington University in Washington D.C., Thomas Moore, wonders, “Should we have relatively dangerous drugs and simply warn people that they might kill or seriously injure them?”  Critics of the FDA think that they expect too much out of a package inserts that are jam-packed in small writing with warnings. 

Some doctors claimed they never saw the warnings and letters issued after the Rezulin label was strengthened.  After Rezulin’s label was changed in late 1997 the FDA found that much fewer than 10% of the Rezulin diabetes drug patients actually got the recommended monthly liver function tests.  FDA medical policy office, Rachel Behrman thinks that in many cases package inserts “are far from perfect.”  Considering the number of serious injuries caused by the use of Rezulin diabetes drug after remaining on the market for three years, Behrman’s hopes to make the package inserts “more user-friendly, more informative, more consistent” may not be enough according to Dr. Sidney Wolfe. 

Directly following the Rezulin recall, Wolfe wrote a letter to the Health and Human Services Secretary Donna Shalala http://www.citizen.org/publications/release.cfm?ID=6717 with a request to enforce the 1958 Code of Ethics for Government Service to “put loyalty to the highest moral principles and to country above loyalty to persons, party, or Government department.”  A 1998 survey performed by Public Citizen found 27 instances in which a medical officer felt a drug should not be approved but was despite their resistance.  Two FDA medical officers had opposed the continuation of the marketing of Rezulin that were called to an internal affairs committee.

The FDA and Warner-Lambert involvement regarding the quick approval of Rezulin and the long stay on the market has been a controversial look at the way the pharmaceutical industry is aggressively entering the market despite serious health complications associated to their drugs.  The Rezulin recall resulted in the death of at least 63 patients because of liver failure and hundreds of other cases of liver failure.  Please contact us to speak directly with an expert Rezulin diabetes drug lawyer.

A 1998 Public Citizen survey found the FDA could require manufacturers to conduct phase IV studies as a condition of approval. According to the reports, at least one phase IV study was required for 195 of 306 new drugs approved by the FDA during the 1990s, but just 11 of the 195 Phase IV studies had been completed. This pertains to the safety of Rezulin because a complete clinical trial was not completed prior to the FDA approval of the diabetes drug due to the "fast track" method used on the drug. After Rezulin was approved, official negotiated a nonbonding pledge from Warner-Lambert to start a new study to assess Rezulin's effect on patients who had preexisting heart disease evidence. Few patients were enrolled, and this study was never completed.