The FDA issued a letter to Eli Lilly requesting more information about their drug Symbyax before approving it for a new use. Symbyax is a combination of Prozac and Zyprexa. Zyprexa is currently the subject of several state-led class action lawsuits due to underreported side effects and marketing of the drug for uses not approved by the FDA.
The FDA made its request for more information on patients’ weight gain and diabetes in what is called an approvable letter, which the agency uses to tell a company what more is needed to gain marketing clearance. The letter hasn’t been publicly released.
“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.”
Eight states have filed class action lawsuits against Eli Lilly. Eli Lilly has no comment over whether the letter will prove harmful to their case in a court of law.
For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.