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Affymax, Inc. (AFFY) Message Board

  • dinepat203 dinepat203 Mar 5, 2013 2:21 PM Flag

    FDA - REPORT SUSPECTED NOT PROVEN

    The side effect reports on Omontys (a.k.a. adverse event reports) in our database comprise the reports submitted to the FDA during a reasonably recent and representative sample period. Information is not vetted and should not be considered as verified clinical evidence.

    It is imporatnt to understand that while this information is potentially useful when analyzed properly (e.g. for post-marketing analysis of drug side effects), it can be easily overinterpreted or misinterpreted, especially by individuals nor versed in medical statistics. For example, a large number of reported side effects for a particular drug may sometimes be more reflective of the large number prescriptions written rather than of unusually high incidence of side effect.

    It is also important to understand that the causative relation between a drug and its FDA-reported side effects is only suspected, not proven. In some cases, a patient may be on multiple drugs, all of which may get reported as a suspected side-effect cause even though only one (or none) may actually be responsible.

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    • Like wise EPOGEN has 16 Death report in REPORT PERIOD OCT 2011 - SEPT 2012
      FDA - Epogen (Epoetin Alfa) - Death - Suspected Cause - Side Effect Reports

      • 1 Reply to dinepat203
      • Possible Epogen side effects in male
        Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14
        Patient: male
        Reactions: Death
        Adverse event resulted in: death
        Drug(s) suspected as cause:
        Epogen
        ----------------------------------------------------------------------------
        Possible Epogen side effects in
        Reported by a physician from United States on 2012-08-13
        Patient: Male
        Reactions: Death
        Adverse event resulted in: death
        Drug(s) suspected as cause:
        Epogen
        Indication: Anaemia
        Aranesp
        Indication: Anaemia
        Other drugs received by patient: Blood Cells; Chemotherapeutics; Blood Transfusion, Auxiliary Products
        --------------------------------------------------------------------------------
        Possible Epogen side effects in 75 year old male
        Reported by a physician from United States on 2012-06-26
        Patient: 75 year old male, weighing 61.0 kg (134.2 pounds)
        Reactions: Dyspnoea, Cerebrovascular Accident, Fall, Hyperhidrosis, Convulsion, Death, Haemoglobin Decreased, Therapeutic Response Decreased, HIP Fracture, Hospitalisation, Myocardial Infarction
        Adverse event resulted in: death, hospitalization
        Drug(s) suspected as cause:
        Epogen
        Dosage: 8000 iu, unk
        Indication: Dialysis
        Start date: 2001-01-01
        End date: 2012-01-01
        Epogen
        Start date: 2002-01-01
        --------------------------------------------------------------------------------
        Possible Epogen side effects in
        Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-08
        Patient: Female
        Reactions: Death, Hypertension, Multimorbidity
        Adverse event resulted in: death
        Drug(s) suspected as cause:
        Epogen
        --------------------------------------------------------------------------------
        Possible Epogen side effects in male
        Reported by a consumer/non-health professional from United States on 2012-04-19
        Patient: male
        Reactions: Death
        Adverse event resulted in: death
        Drug(s) su

 
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