Is this BRAND really different?

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I am sure this will amaze you as much as it did I.  Naproxen- the over the counter drug sold by (almost) everybody and their grandmother- is different from different vendors.  Besides being sold as generic Naproxen, it is also sold under various “brand” names-  Aleve, Naprelan, Naprosyn, Anaprox, Apronax.

It may turn out you should be buying Aleve-  the Bayer version. (I say you, because I am allergic to the stuff.)   The data seems to indicate that cardiac risk from taking Aleve may be alleviated (pun intended) compared to the rest of the pack.

This is not from just one study, either.  Several tests over the past 8 years have demonstrated these results.  As such, the FDA has called for an advisory committee meeting (of its cardiology group).  (Bayer has repeatedly requested the right to present these results to the public.)

The committee examines information on all the NSAIDs (non-steroidal, anti-inflammatory drugs).  So, they will be reviewing data for ibuprofren and naproxen- both generic and branded.  Why did the FDA wait so long to have a review?  Maybe because it felt burned by Vioxx (rofecoxib), the Merck drug that was pulled from the market because of cardiac risks- which was he time that the FDA demanded the posting of a warning on boxes of NSAIDs alerting users about their potential elevated cardiac risks.

But, now a series of studies have (a new Danish study has been published in Circulation) examined the effects of the various drugs on heart attack survivors.   But, the data really needs a statistician to explain the results (the increased chance of a second heart attack was 45% after starting the medication a week after a cardiac event and 55% after 90 days). But, the actual rate of dying was <6 per 10,000 people in the 84000 person study group for those who took NSAIDs, while the group as a whole managed to keep that risk to about 3 or 4.   But, among the NSAIDs, naproxen posed the lowest risk.

Data from the article by Coxib and traditional NSAID Trialists' (CNT) Collaboration
The Lancet, Volume 382, Issue 9894, Pages 769 – 779, 31 August 2013

Based upon the Danish results and the other studies (such as this analysis found in last year’s Lancet, the esteemed British medical journal) , Bayer wants to change its product label warnings.  It believes that the heart safety of naproxen is evident at both prescription and over-the-counter dosages.

But, the committee finally met on the 11th of February.  And,  the FDA panel said NO. Naproxen, the active ingredient in Aleve, will not be allowed to claim that it poses a lower risk of cardiovascular problems than ibuprofen or other similar drugs.  The panel’s vote was 16 to 9, despite the article in the Lancet, Circulation, among others, all indicating there seems to be a lower risk.

So, I guess Bayer will be sponsoring more trials, developing more data, trying to convince the FDA of the merits of its case.

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19 thoughts on “Is this BRAND really different?”

    1. I was very surprised. I know that a lot of the vendors choose different fillers- but I assumed the active ingredient was the same Unless it’s some adjuvant that they add, that multiples the effect (or is that decreases the effect?)

  1. I think I’m going to have to give Aleve a try the next time I need an anti-inflammatory. I always thought Ibuprofen was pretty safe and never even knew that it posed a cardiac risk!

    1. It is more pronounced when you take the prescription dose, which is higher. And, to be honest, that was what Aleve was hoping would be approved this past few days. Their OTC (over the counter) version is another issue.

  2. What’s going on here, someone with more pull that Bayer is keeping them from changing their label to their advantage. I think the saddest thing here is that most people don’t read enough to know that there might just be a problem with these over the counter drugs.They feel that if it is over the counter it must be perfectly safe.
    Chef William recently posted..Jalapeno Poppers And Chicken Enchilada Casserole

    1. I’m not sure it’s more pull. But, maybe more definitive data is needed to let Bayer make that claim. Because it’s a statistical gain- one not clearly evident…yet. But, that does not mean if I were able to take Aleve, it would not be my primary choice, Chef William.

  3. This post confirms what I suspected: we don’t really understand the subtle differences between ‘similar’ drugs. As a result, I try to stick to what my grandma used to say: don’t take meds unless you really need it. Sound advice.
    Muriel recently posted..Thom’s Tree

  4. Pingback: NSAID Safety? |

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