Institute of Medicine Says FDA Needs Drug Safety Tracking Database

With the outrageous number of pharmaceutical drugs on the market today, I’m sure some doctors dream of a database that is easily accessible, that contains all information about side effects, contraindications and how to prescribed each medication. Thus a leading public health advocacy group has suggested the Food and Drug Administration (FDA) approve a comprehensive system for tracking adverse reactions and dangerous side effects of prescription drugs once they reach the U.S. market.

According to a HealthDay News the Institute of Medicine has suggested the FDA work to create a publicly-accessible database tracking these reports concerning prescription drugs. The database should, according to the report, contain a “risk- and benefit-assessment plan for each drug” and that information should include data from the time the drug reaches the market until the time it is removed.

That data should also include known side effects of the drugs, including individual incident reports on the patients who suffered those complications. Additional side effects should be noted as they appear among patients taking the drug. In addition to those reports, the FDA should also include any regulatory action the agency has taken on a particular drug.

Institute of Medicine believes having such a database in place will hopefully avoid some of the catastrophic failures of prescription drugs in the past, particularly the painkiller Vioxx, the Type 2 diabetes drug Avandia, and the cholesterol drug Crestor. Each drug was widely available and prescribed by doctors to millions of patients unbeknownst to them each party of the risks each drug carried. Data on the side effects suffered by patients taking these drugs was not widely reported as they were occurring and hence, more doctors prescribed the drug because the only information that was readily available did not make mention of the dangerous and life-threatening side effects being suffered by people currently taking the drugs.



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