Lilly Not Out of the Woods Yet Over Zyprexa
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New speculation has risen over Zyprexa since a letter from the FDA to the drugmakers was leaked. Apparently in March, the FDA sent a letter to Eli-Lilly telling Lilly that they would delay the approval of their new drug Symbyax, which is used to treat depression. Symbyax was not approved because it is a combination of Zyprexa and Prozac, and more info was needed about the risk of diabetes in the prescribing label.
According to Pharmalot, “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 its letter.” Bloomberg who is the original source of the letter said that this information “may bolster plaintiffs' suits against the Indianapolis company over side effects tied to Zyprexa, lawyers said. Lilly has paid more than $1.2 billion to settle 29,000 claims that patients weren't adequately warned that Zyprexa can cause diabetes, weight gain and pancreas infections.”
David Logan, dean of the Roger Williams University School of Law in Bristol, Rhode Island said in an interview, “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. It would likely carry some weight with juries.”
In addition to all the individual claims filed against Zyprexa, 8 different states have sued Lilly on behalf of Medcaid health program, claiming that Lilly concealed risks and marketed Zyprexa for unapproved uses.
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Greg Edwards is the author of many health related articles as well as the owner of a consumer advocacy website. Visit this Consumer Advocacy website for more information on ordering medication from online with no prescription
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