According To Bloomberg Report, FDA Wants Information About Weight Gain And High Levels Of Blood Sugar Added To Zyprexa Label
(Posted by Tom Lamb at DrugInjuryWatch.com)
On June 29, 2007 Bloomberg published an article by its reporters Rob Waters and Margaret Cronin Fisk about a March 2007 "approvable letter" that the FDA sent to Eli Lilly & Co. on its drug Symbyax, which is a combination of Lilly's antipsychotic drug Zyprexa and the antidepressant drug Prozac.
According to this June 29 Bloomberg article, the March 2007 letter stated that the FDA "would delay the approval of Symbyax for depression because the agency wanted more information about the risk of diabetes in the medicine's prescribing label."
The reporters said in their article Bloomberg had obtained a copy of this letter by Thomas Laughren, director of the FDA's division of psychiatry products, although "the letter hasn't been publicly released."
Bloomberg's June 29 article provides this content from and description of the Symbyax FDA letter:
"We are concerned that the proposed labeling is deficient with regard to information about weight gain" and high levels of sugar and fat in the blood of patients who took the drug, the FDA said in the letter, referring to proposed prescribing information on Symbyax. "We do not feel that current labeling for either Symbyax or Zyprexa provides sufficient information on these risks." ....
Lilly's proposed prescribing information for Symbyax failed to disclose that almost half of patients who had high or borderline levels of blood sugar when they started taking the drug ended up with levels high enough to be considered diabetic, the FDA said in its letter. That was more than nine times the number of patients on placebos, or inactive dummy pills.
"We were troubled that this important information was not included in your proposed label," the agency said in the letter.
As covered previously, Lilly has already settled more than 29,000 Zyprexa claims brought by patients alleging that were not adequately warned that Zyprexa can cause diabetes other serious side effects.
As background, the FDA required Lilly and other drugmakers in September 2003 and, again, in March 2004 to warn that Zyprexa and other atypical antipsychotics are associated with weight gain and an increased risk of diabetes.
More recently, this March 2007 FDA letter concerning Symbyax reportedly says that the current label for Zyprexa is still insufficient in terms of its information about the risks of weight gain and blood sugar problems associated with Zyprexa.
As regards the affect of this March FDA letter on the current Zyprexa litigation: First, it will seemingly benefit the plaintiffs in those cases have been filed but not settled and, second, it may allow additional, new claims to be filed that were previously thought to be barred by operation of the statute of limitations, i.e., filing deadline, in most states.