Adverse events product safety

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. 

The FDA approved label is the official description of a drug product and includes what the drug is used for who should take its adverse events (side effects) instructions for use in pregnancy, children, and other populations and safety information for the patient. Labels are often found inside drug product packaging. 

As manufacturers are not required to submit safety information before marketing dietary supplements, the FDA must rely on adverse event reports, product sampling. 

To simplify the process, it is important that a single database is developed for the whole programme. This is particularly relevant to the production of safety data, not only in the interests of efficiency but also so that any safety issues will be recognised as they arise. If a particular set of adverse events is suggested by preclinical toxicology then they should be flagged in the database so that the monitors attention is drawn to them. 

Underreporting of adverse events of medication is a global phenomenon. It applies to prescription and over-the-counter medicines and undoubtedly the same is likely to be true for CAM treatments. However, manufacturers of alternative treatments do not provide ongoing monitoring of the safety of their products that is comparable to that of pharmaceutical companies. 

G. Other considerations Serono conducted the comparative study to demonstrate that Rebif is clinically superior to Avonex. No other path was available for Serono to have the product licensed by the FDA before mid-2003 because Avonex carried an orphan drug designation based on its superior safety profile over Betaseron, the first interferon beta to be licensed for multiple sclerosis. Based on the results of the Rebif versus Avonex study, the FDA determined that Rebif is clinically superior to Avonex. While recognizing that the safety profile associated with Rebif is not as favorable as the safety profile of Avonex, the FDA has determined that the severity and frequency of such adverse events do not render Rebif unUcensable under Section 35 of the Public Health Service Act. Further, under the orphan drug regulations, if Serono demonstrates that Rebif is superior to Avonex based on efficacy, Serono does not have to show that Rebif is safer than, or as safe as, Avonex. 

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. 

A number of variables influence the likelihood of an adverse event being reported. These include the length of time that a product has been marketed, the market share, experience and sophistication of the population using the product, and publicity about adverse events. Currently there is little incentive for health professional reporting of adverse events, which partially imderlies the problem with underreporting. Lack of exposure data and the issue of underreporting preclude estimation of incidence rates. Causality assessment is difficult or impossible because of the quality of the data received and the lack of a comparator (control) group. Finally, comparisons of product safety cannot be directly obtained from adverse event data. 

Accepts reports from consumers and health professionals about products regulated by the FDA, including drugs and medical devices, through Med-Watch, the FDA s safety information and adverse event reporting program. (800) 332-1088... 

The United States is not the only country concerned about the safety of ephedra. Health Canada, the Canadian health regulatory agency, requested a voluntary recall of products containing both natural and chemical ephedra in 2002, because it received 60 reports of adverse events related to ephedra use. 

Test products were well tolerated with infrequent and minor adverse events. With regard to safety outcomes, hematologies and serum chemistries tracked throughout the intervention within two standard deviations of baseline values. 

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