What Should FDA Do About Ibuprofen?

What Should FDA Do About Ibuprofen?

June 4th, 2013 // 12:20 pm @

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A Reuters story recently stated that using ibuprofen in long term, high doses is just as hazardous in terms of cardiac risks as using Vioxx, which was withdrawn from the market due to heart dangers. Reuters was referencing a study that was reported recently in the British medical Journal called The Lancet. The article noted that for every 1000 people with an average risk of cardiac problems who took high doses of ibuprofen for one year, about three more people would have had a heart attack that could have been prevented, and one would have been fatal.

Overall, the risk/benefit ratio is still reasonable, especially if you realize that all drugs have side effects, including aspirin. But, for people who are in need of pain meds to deal with arthritis, this is a report that is a concern. Many arthritis patients are older, obese and are somewhat limited in their ability to exercise. All of these things make them more likely to suffer from heart problems. but the medication that they need to reduce their pain can make them more likely to have heart problems.

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It is not new that NSAIDs can pose heart risks. But the new data is raising concerns because OTC drugs are being found to pose a similar heart risk as Vioxx. The problems is that many people view OTC drugs as a lot safer than Rx drugs. If you don’t need the permission of a doctor to buy it, then it must be safer. Also, many people do not read the labels, and think if two pills is good, then three or four must be better, and after all, it can’t hurt me if I don’t need a prescription to get it. But the new report in the Lancet indicates that an OTC medicine may have as much risk as a prescription drug that was removed from the market.

So, what should FDA do? Ibuprofen has been on the market for many years and is used for pain by hundreds of millions of consumers. For most of us, the drug is totally safe. But there is a small population out there for whom the drug is not safe. For drugs that you need a prescription for, FDA has doctors who can talk to patients about the risks. But with ibuprofen, this is not possible. People could take the NSAID and not know of the heart risks.

FDA could of course pull iburprofen from shelves and make it only available by prescription. But most people would view this as going too far. But if FDA does not act at all, isn’t it really accepting that three of every 1000 people are going to have a heart attack that could be avoided? What do you think FDA should do?

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