Thread: New FDA website lets public find drug safety info

New FDA website lets public find drug safety info

Updated 32m ago
By Rita Rubin, USA TODAY

WASHINGTON — The Food and Drug Administration launched a website Tuesday where patients and health care professionals can find safety information about recently approved drugs and vaccines.

On the Postmarketing Drug Safety Evaluations site, the FDA plans to share what it has learned about the safety of a new drug or biologic, such as a vaccine, 18 months after approval or after 10,000 patients have used it, whichever comes later.

The agency is making a "broad sweep" of adverse-event reports, medical studies and research, and drug utilization databases to look for safety problems, Robert Boucher, an official in the FDA's Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research, said at a news briefing.


ON THE WEB: FDA.gov
http://www.fda.gov/Drugs/GuidanceCompli ... 090385.htm

The agency has drawn criticism in recent years for not paying enough attention to safety once drugs are approved and enter the "real world," where they're used by much larger and more diverse groups of patients than those in pre-approval trials.

For example, Boucher said, clinical trials often exclude the elderly, children, ethnic minorities and pregnant women. In addition, he said, clinical trials exclude patients who might take the drug for an unapproved use or at the same time as other drugs, both factors that could affect safety and effectiveness. Rare but serious side effects might not crop up until after a drug is approved and taken by many thousands of patients, often for longer than trials lasted, he said.

The 2007 FDA Amendments Act authorized the agency to review postmarket safety and post summaries of adverse reactions for recently approved drugs. According to the law, the FDA is supposed to identify previously unknown risks, potential new risks and known risks reported in unexpectedly high numbers.

The FDA posted postmarket safety evaluations Tuesday for 26 drugs approved between September 2007 and January 2008 and is reviewing an additional 20 or 30, Boucher said. The first 26 range from Anthelios 20, a sunscreen cream, to Afluria flu vaccine to Simcor, a combination of a statin and niacin to lower cholesterol.

Those three drugs were among 18 for which the FDA found no unexpected serious side effects. For the other eight, the agency found that serious adverse effects either were already described on the label or were related to the patient's condition, so no label changes were recommended.

"That's just the luck of the draw," Boucher said.

http://www.usatoday.com/news/health/201 ... 6_ST_N.htm

We need a secure data base where people can self-report adverse effects, where doctors are required by law to report patient claims of adverse effects and allow this data to be collated and statistics draw by researchers who can contact the claimants to determine common factors that they have - which is often ethnicity.

We do have some research to prove that some people cannot process Rx and do become ill, for example the CYP2D6 enzyme pathway. Doctors do not have the education or resources to know how to prescribe for these patients and therefore they are often more comfortable practicing patient dumping which once again drives up the cost of healthcare.

Another avenue of research that needs to be done is how long-term use of some Rx permanently alter the patient's enzyme and endocrine structure, also making them incapable of proper utilization of prescription therapies, and often putting them at death's door as a result.

So while this site is a good start it is merely a drop in the bucket. Plenty of private people have tried to put this info on the web so I suspect the intentions. We need that national data base but unfortunately none of us has any confidence in the integrity of anybody to keep the data private and uncompromised - for research use only.