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In an unusual rebuke, AbbVie (ABBV) was reprimanded by the Food and Drug Administration for sloppy procedures when reviewing complaints of deaths that were reported in connection with three of its medicines, including the best-selling Humira rheumatoid arthritis treatment.

Following an inspection at a North Chicago, Il., facility late last year, FDA examiners found the company failed to “thoroughly investigate” complaints over certain syringe kits for its Lupron medication that were associated with deaths, according to an inspection report that was issued by the agency last Dec. 15, and was obtained by STAT, but is not yet available on the FDA web site. Lupron is used to treat endometriosis and uterine fibroids, among other illnesses.

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  • They outsource the case processing to India. Merck outsources all adverse event reporting to India, China, and Brazil. Abbvie outsources to India. All of a patient’s information and data regarding the AEs go to these foreign countries. Has the FDA really audited this process since they want qualified people involved in handling adverse events? Has HIPAA? Has the Department of Labor?

  • There are thousands of us that have been severely hurt by Lupron.
    FDA, AbbVie, and Doctors are well aware of this and yet NO ONE WILL TAKE ON BIG MONEY, maybe it’s because they all have stock with the drug company or maybe many of them are getting paid to cover up this deadly drug!
    I almost forgot that we have also sent a petition to CONGRESS as well!
    I hope one day everyone involved with Lupron will have to pay for what they have done and continue to do to everyone with this poison.

  • Once again, get your facts straight. Abbott and Abbvie are two separate companies.

    • Looks like we have another correctionist back on campus. Posters watch your spelling when Mike Z is around! Hey pal, I worked for Abbott before there was Abbvie and probably before you reached puberty, but whatever you call them they both have a long history of ignoring AE’s. Now you can go back to your thesaurus and return when you have something to contribute besides grammatical, spelling or historical errors.

  • Simple fix. When these terrible results are found the CEO should be put on the protocol until they expierence the results reported. The industry will become the safest in history,after that.

    • I can’t take any comment seriously when easy to spell words are not spelled correctly. It makes me question your level of education.

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