Efficacy and safety of infliximab in steroid-dependent ulcerative colitis patients

Upon completion of this activity, participants should be able to:

  • State the mission of CDER
  • Describe the drug development and review process in the United States for new drugs, generics, over-the-counter (OTC) drugs, and biosimilars
  • Discuss how CDER functions to ensure drug and medical product safety post-marketing and protection of public health
  • Identify ways CDER disseminates safety information about medical products to both health care professionals and their patients
  • Describe how to report an adverse drug event or a marketed medical product problem to the FDA using the MedWatch program

Adverse effects that occurred during the 90-day trial period are summarized in Table 5 . Overall, there were 58 adverse events noted in the subjects receiving G+C treatment, whereas, only 35 adverse events were observed in UC-II group. In terms of severity, 60% of mild and 38% of moderate adverse events were experienced by subjects on G+C in comparison to 43% and 54% by subjects on UC-II. In relationship to test product a higher number of subjects (23%) on G+C demonstrated adverse events possibly related to product as compared to % of subjects on UC-II. For UC-II the possible adverse events related to products were constipation and headaches (intermittently). For G+C the possible adverse events related to products were bloating, stomach pain, rash, water retention (edema around eyes and scars), hives on face and chest, and headache. However, there was no significant difference in the occurrence of adverse effects between the two treatment groups.

Efficacy and safety of infliximab in steroid-dependent ulcerative colitis patients

efficacy and safety of infliximab in steroid-dependent ulcerative colitis patients

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