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Report: FDA Expresses Concern over Risks of Eli Lilly's Symbyax, Zyprexa
by Daniel Beaulieu
June 29, 2007
Bloomberg obtained a copy of an FDA approvable letter sent to Eli Lilly in March regarding the expanded approval for Symbyax for patients with hard-to-treat depression. In the letter, which had not been made public, the agency requested that the drug's label include more information about the risks of weight gain and diabetes. The compound, which is currently indicated to treat depressive episodes associated with bipolar disorder, is a combination of Eli Lilly's Zyprexa and Prozac.
The FDA stated in the letter that "we are concerned that the proposed labeling [for Symbyax] is deficient with regard to information about weight gain' and high levels of glucose and fat in the blood of patients receiving the drug.”We do not feel that current labeling for either Symbyax or Zyprexa provides sufficient information on these risks," the FDA noted. The agency also expressed concern that proposed prescribing information for Symbyax did not disclose data showing that almost 50 percent of patients with high or borderline blood glucose levels at the start of treatment ended up with levels high enough to be considered diabetic, which was more than nine times the rate of patients who received placebo.
In response, Eli Lilly spokesperson Carol Puls said that the information the drug maker initially proposed to include on Symbyax's label was "just a starting point," adding that the company is prepared to provide additional data at the FDA's request.
Furthermore, the FDA's comments in the approval letter may benefit plaintiffs who have filed lawsuits against the drug maker over allegations that the company failed to warn patients about Zyprexa's risks, according to legal experts. "When the FDA says something damning about the warnings of a drug, it's admissible as evidence on the reasonableness of the manufacturer's decisions," commented David Logan, dean of the Roger Williams University School of Law.
Eli Lilly has so far paid more than $1.2 billion to settle 29000 claims over Zyprexa. Several US states have also filed lawsuits against the drug maker alleging that the company concealed risks and marketed the product for unapproved uses.
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