By George Anderson
A professor of pharmacy at the University of Tasmania says many of the problems that led to Vioxx being withdrawn from the market can be found in a popular anti-inflammatory drug that consumers purchase everyday right off the shelf in retail stores.
According to Gregory Peterson, the use of ibuprofen has been linked to an increased risk of heart attacks, asthma, gastrointestinal problems and miscarriages.
While medicines contain ibuprofen contain warning labels, Professor Peterson says many consumers in Australia either do not read them or discount them as not being applicable to their personal case. The mere fact the product is sold on store shelves gives at-risk consumers the sense that it is safe for them to use, he argued in an opinion piece published in the Australian Journal of Pharmacy.
"This is the real problem - you've got to catch one-in-five of the adult population that have these risk factors and aren't sufficiently aware of the problems and there's no safeguards in place in a supermarket," he wrote.
Professor Peterson is not calling for ibuprofen to be taken off the market, simply reclassified. "It's certainly a safe drug for short periods in relatively fit young people [but] probably the other consumer is at risk - the older patient - those on multiple medications, those with underlying cardiac or other diseases or an increased risk of adverse events from ibuprofen."
As with other drug controversies, Prof. Peterson believes there are issues with some of the studies used to support the case for approving ibuprofen for OTC sale in Australia in the first place.
"The original study in which a lot of the case was built to make ibuprofen over the counter was the study supported by the manufacturer of that drug and in hindsight, there are a number of flaws with that study," he wrote.
Moderator's Comment: Will the call for reclassifying of ibuprofen in Australia have any impact elsewhere? Does the U.S. need a third class of drug sales designation beyond OTC and Rx to protect consumers while not unduly restricting their access to them? - George Anderson - Moderator