FDA Warning Letters to Pharmaceutical Companies in 2009

fda_mast_01Warning Letters and Untitled Letters to Pharmaceutical Companies in 2009 here you will get the following information-


  1. Product/Issue
  2. Company/Individual
  3. Division/Office
  4. Released Date
  5. Posted Date

http://www.fda.gov/cder/warn/warn2009.htm

3 Responses to FDA Warning Letters to Pharmaceutical Companies in 2009

  1. I. Graham says:

    Just looking for information re the Side Effects of Actonel taken for osteoporosis. Specifically if there have been studies which show back, muscle, and/or joint pain are relatively common.

    Xrays indicate that I have a degenerating disc and osteoarthritis which I know are common for my age (74)

    I know these are listed as Side Effects, but both my Doctor and Pharmacist say back pain is not at all common or even relevant, only Upper GI problems or jaw pain. I have severe back pain for several days after taking Actonel but it lets up after a week or so. The pain is to the extent that I have to sit down after 5 minutes of activity but then able to get up and do a bit more work.

    Can you direct me to a Report or Study that would verify that this back pain could probably be due to taking Actonel. I stopped taking it and for 3 weeks have been almost pain free.
    I would like some written data to show to my Doctor.
    Thank you.

  2. Carl's Blog on FDA Stuff says:

    Hi,

    I’m curious about access to Untitled letters. You only list Warning Letters here. Do you have a link for Untitled Letters???

    Thanks,

    Carl

  3. Hi Carl,

    Please have look into this link where you have combination of 2009 Warning Letters and Untitled Letters to Pharmaceutical Companies

    http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm055773.htm

    Please let me know if this helps you.

    Regards,
    Abhishek

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