Watchdog Says FDA Needs Drug Safety Tracking Database

Watchdog Says FDA Needs Drug Safety Tracking DatabaseA 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 report on a new study from the Institute of Medicine, the group recognizes that a public clearinghouse for easily accessible information on the potential dangers of prescription drugs does not exist. In some countries, the public and physicians have access to a database which tracks reported side effects and adverse reactions to drugs. Domestically, patients are left to rely upon the recommendations of their physicians or through their own research from a variety of sources. Physicians rely on information they glean from medical journal reports and from colleagues as well as representatives of drug companies for the latest information on potentially dangerous drugs.

In its study, Institute of Medicine 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.

In addition to the database on information on a drug’s “life cycle” once it reaches market, the FDA should only order post-market safety testing in cases where a drug’s true safety profile can not be determined on the information publicly available. The agency should order drug makers to conduct these studies and make that information public as soon as possible to mitigate the potential dangers of the drug. This would also allow the FDA to take any necessary additional regulatory action, such as the placement of new warnings of side effects on a drug or to revoke an approval because it determined taking the drug presents more risks than benefits.

Under the current system, it takes a flurry of reports on potential dangers of a drug to get the FDA to act on a particular product. That could be the result of numerous faults of the regulatory approval process but the study authors believe having a running record of drug complications would compel the agency to act quicker and potentially stave off future injuries and deaths blamed on a drug’s seemingly unknown risks.

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