Postmarketing data

Analysis of Postmarketing Data with MGPS and HBLR... 

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]. 

Hepatotoxicity Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis, have been reported rarely in postmarketing data in patients receiving infliximab. Autoimmune hepatitis has been diagnosed in some of... 

Lawrence KR et al Serotonin toxicity associated with the use of linezolid A review of postmarketing data. Clin Infect Dis 2006 42 1578. [PMID 16652315]... 

To report postmarketing data or information that might cause the FDA to reassess the safety and effectiveness of the product... 

Phase IV— Postmarketing Data retrieval from market... 

Category D Positive evidence of risk investigational or postmarketing data show risk to the fetus. Nevertheless, potential benefits may outweigh risks... 

It has been argued that deaths on sildenafil largely reflect the fact that it is used by patients at high cardiovascular risk. But recent postmarketing data shows that death is 50 times more likely after sildenafQ taken for erectile failure than alprostadil, the previous first-line agent. Mitka M 2000 Journal of the American Medical Association 283 590. 

Successful postmarket data collection, like premarket clinical trials, relies on physicians and patients to follow prescribed social norms. Each of the institutions described here tried to structure the doctor-patient relationship to produce objective and interpretable reports about drugs outside of the controlled clinical setting. In both countries, government authorities and the medical profession expected patients to recognize adverse reactions, assist physicians in reporting them to central authorities, and then continue to take other prescription drugs. However difficult it may be to discipline patients to report adverse reactions, physicians too must be trained to complete and submit forms. A standardized product requires a standardized producer. Authorities... 

Investigational or postmarketing data show risk to the fetus. 

The effects of HPV vaccine on pregnancy outcomes (live births, abortions, fetal deaths, and congenital anomalies) have been analysed using postmarketing data from the USA, France, and Canada [28 ]. Among the 517 prospective reports with known outcomes, 451 (87%) were live births, including three sets of twins. Of 454 neonates, 439 (96.7%) were normal. The overall rate of spontaneous abortions was 6.9 per 100 outcomes. The prevalence of major birth defects was 2.2 per 100 live-born neonates. There were seven fetal deaths (1.5 per 100 outcomes). Rates of spontaneous abortions and major birth defects were not greater than in the unexposed population. 

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