RxISK.org — A Megaphone for Patients and Their Doctors to Help Change Drug Safety

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Free online tool empowers as it informs users about drug side effects.

Search. Report. Contribute.

Many people think that if the FDA or their country’s drug regulator has approved a drug then it’s safe. Not always.

RxISK.org, the first free independent website for researching and reporting drug side effects, is now live. RxISK.org layers an easy-to-use interface over data from FDA’s MedWatch system, allowing users to search the 4.1 million drug side effect reports from 2004 to June 30, 2012 and see information unavailable anywhere else, including warnings and interactions, tag clouds, heat maps, and interactive graphs. Users can search more than 35,000 prescription drug names from 103 countries.

The website has a unique reporting feature that provides users with a personalized RxISK Report linking their side effects and their meds. This report can be taken to a doctor or pharmacist to facilitate a better treatment conversation. RxISK will also show what’s happening with other people taking the same drug around the world and in the user’s community.

As more reports are filed, the RxISK database will become the most comprehensive source of independent information on what drugs do.
Many people think that if the FDA or their country’s drug regulator has approved a drug then it’s safe. Not always. All drugs have effects. Some good, some bad, and some deadly. But fewer than 5% of “serious” drug side effects — those leading to hospitalization, disability, or death — are reported.

Drug side effects are the fourth leading cause of death in hospitals and the number one cause in some health domains. But with such a huge data gap, it often takes a decade or more for doctors to hear about serious hazards or for country regulators to take action.

The RxISK.org website is a solution to a problem outlined by Dr. David Healy, world-renowned psychiatrist who has written extensively about the lack of data in evidence based medicine, especially in his latest book, Pharmageddon.

“I didn’t want to just moan about the problems we are facing with drug safety,” says Healy, who with the help of like-minded colleagues, created Data Based Medicine Americas Ltd. with the purpose of developing a website that would be independent of advertising and government funding and that would get to the root of the issue.

“No one knows a drug’s effects like the person taking it, and yet this voice has been silenced,” says Healy. As a result, medicines have become riskier rather than safer. “The Avandia and Vioxx tragedies clearly show that the system is not working. The problem is huge and will only get worse.”

Healy says he is also concerned about the data that is reported. “What many people don’t realize,” he says, “is that most drug side effects that are reported come from drug companies, which can manipulate and filter what they report to a country drug regulator."

RxISK.org also enables users to easily report directly to their country’s drug regulator, such as the FDA in the United States, Health Canada in Canada, and Yellow Card in the United Kingdom.

Dr. Dee Mangin, Data Based Medicine’s Chief Medical Officer and a family doctor in Christchurch, New Zealand and a professor and Director of Research in the Department of Public Health and General Practice in the University of Otago, says that not only can the RxISK data save lives, but it can also save money. “There are enormous costs to patients, health insurers, and governments,” says Mangin. “Globally, the direct costs of drug side effects are US$12.5 billion and the indirect costs are US$250 billion. With the right data and intervention strategies, many of these costs are avoidable,” she says.

The collection of accurate, reliable data can also be a catalyst in the development of new drugs or new uses for existing drugs. This is exactly what happened with Latisse, which was originally prescribed for glaucoma patients who noticed darker, fuller eyelashes from their eye drops, and Viagra, which was originally developed to treat pulmonary arterial hypertension.

“Watching out for unexpected effects has often been an effective way to discover new drug uses,” says Mangin. “At a time when new drug discovery has dried up, we need people more than ever to report the full range of things that happen to them on treatments.”

Healy says the RxISK.org website is designed to “give patients a voice and help them and their doctors gain insight into the real life experiences of other people on the same prescription drugs.”

About Data Based Medicine Americas Ltd.
RxISK.org is owned and operated by Data Based Medicine Americas Ltd. (DBM), based in Toronto, Canada. DBM's founders have international reputations in early drug-side-effect detection and risk mitigation, pharmacovigilance, and patient-centered care. Although drug side effects are known to be a leading cause of death and disability, less than 5% of serious drug side effects are reported. DBM’s mission is to capture this missing data directly from patients through RxISK.org’s free drug side effect reporting tool and use this data to help make medicines safer for all of us.

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David Carmichael
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