Postmarketing adverse events reporting

Hepatitis Cases of cytolytic hepatitis and hepatitis with jaundice have been observed in the addict population receiving buprenorphine both in clinical trials and in postmarketing adverse event reports. 

Sample Electronic NDA Submission Postmarketing Adverse Events Reporting... 

The majority of gemifloxacin adverse reactions experienced by patients in clinical trials were considered to be of mild to moderate severity, primarily due to rash (0.8% of patients), nausea (0.3%), diarrhea (0.3%), urticaria (0.2%), and vomiting (0.2%). Most of the postmarketing adverse events reported were cutaneous and most of these were rash. Some of these cutaneous adverse events were considered serious. The majority of rashes occurred in women and in patients under 40 years of age. 

In postmarket snrveillance stndies, specific and structured data collections are required of the manufacturer in one of two situations as a condition of product approval, or to reaffirm product safety when postmarket adverse event reports suggest that pre-market safety claims are inconsistent with actual use and result in unacceptable risk. 

Postmarket monitoring, through sampling, adverse event reporting, surveillance activities, and response to public inquiries... 

NDA requires manufacturers to submit product-labeling language, which describes the proper use, benefits, and risks of the product in question. FDA may also require, as a condition of approval of an NDA or BLA application, that postmarketing studies be conducted to monitor and confirm the safety and efficacy of a product as it is used more widely in clinical practice. In addition, all sponsors or manufacturers are required to monitor and report adverse effects, defined as health effects that may or may not be related to the drug in question. For vaccines, adverse events that occur after immunization must be reported to the Vaccine Adverse Event Reporting System. 

Bromfenac 0.09% (Xibrom, ISTA) has been approved for topical application outside the United States for many years. Bromfenac has compiled an excellent safety record with only 13 reported postmarketing adverse events among 6 million prescriptions written. Perhaps its greatest advantage is reported less initial stinging on instillation (1.5% vs. 20% to 45% for ketorolac 0.4%).The current FDA approval is for the management of postoperative cataract surgery pain. 

Shaw FE Jr, Graham DJ, Guess HA, Milstien JB, Johnson JM, Schatz GC, Hadler SC, Kuritsky JN, Hiner EE, Bregman DJ, et al.. Postmarketing surveillance for neurologic adverse events reported after hepatitis B vaccination. Experience of the first three years. Am J Epidemiol 1988 127(2) 337-52. 

Untoward vaccine effects are variable, manifesting from injection site irritation, fever, and irritability to encephalopathy, paralysis, and even death. - " " Reporting of certain vaccine adverse events to the Vaccine Adverse Event Reporting System (VAERS) is mandatory. VAERS was established by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to facilitate the process of gathering postmarketing surveillance data on vaccine-related adverse events. VAERS reports record adverse events temporally but not necessarily eausally associated with vaccination. 

Similarly, a review of human clinical trials (including over 2800 participants), postmarketing surveillance, and uncontrolled case reports on black cohosh indicated a low incidence (5.4%) of adverse events in persons taking black cohosh. Of the adverse events reported, 97% were minor and the severe events were attributed to causes other than black cohosh use (Low Dog et al. 2003). 

In postmarketing electronic longitudinal medical records, redundant and potentially contradictory information may come from several sources, (e.g., reports from medical residents, their supervisors, the attending physicians). In these cases time stamping of each event may help to delineate the important sequences in understanding the adverse events. 

Limited Knowledge of Exposure and Reporting Rates in Postmarketing Data. Unlike clinical trials and electronic medical records in clinical practice, postmarketing voluntarily reported data contain limited information about the total number of patients exposed and the duration of exposure. This problem is compounded by the fact that adverse events are often underreported [2,9]. 

From 1978 through 1990, the Centers for Disease Control and Prevention (CDC) and the Food and Drag Administration divided the responsibility for postmarketing surveillance of vaccines in the United States. FDA received reports of adverse events after vaccines were administered in the private sector events occurring after the administration of vaccines purchased with public funds were reported to the Monitoring System for Adverse Events Following Immunization. 

The astute individual healthcare practitioner is the critical link in the postmarketing surveillance of medical products. One reporter can indeed make a difference in a newly approved drug s postmarketing phase. Only through the diligence of individual practitioners, such as pharmacists, can FDA hope to monitor the adverse events associated with newly marketed products and determine their safety for patient use. 

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