When an FDA Panel says: CV Safety of Celecoxib Similar to Naproxen, Ibuprofen the obvious observation is that Naproxen and Ibuprofen aren’t very safe either! All these NSAID drugs hurt the heart, they all deplete magnesium, they are for short term use only (10 days or less) and even short term use can harm the heart. But doctors who think they have no other options prescribe them for years.
Instead of studying Celecoxib (AKA Celebrex) against a placebo, where it would have failed, it was studied against two other NSAIDs. It’s like comparing one bad apple to another bad apple with the outcome that they are all welcomed with open arms by the FDA.
Celebrex side effects include a 37% increase in incidence of major vascular events, which include nonfatal heart attack, nonfatal stroke, or death from a blood vessel-related cause. Additionally there is an 81% increase in incidence of upper gastrointestinal complications, which include perforations, obstructions, or gastrointestinal bleeding as in all nonsteroidal anti-inflammatory drugs. In July 2015 the FDA strengthened the warning that non-aspirin NSAIDs can cause heart attacks or strokes.
But still these studies persist and the drug companies persist in finding ways to keep selling their drugs. This latest foray into the heart of the FDA has the panelists hemming and hawing because they know the FDA wouldn’t be able to survive without FDA funding.
Here’s how they hedge the real issues of drug safety.
Panelist: “I agree [that the study] did show that Celebrex is not more dangerous than the other two nonsteroidals…there wasn’t a placebo group to show how poor they would do.”
Panelist: “I voted [that the…trial did not demonstrate comparable CV safety for celecoxib as compared to naproxen and ibuprofen]. My major concern is the word ‘safety’…it perhaps demonstrated noninferiority, but not safety necessarily.”
Panelist: “I voted ‘yes’ with the caveats that the recommendations are limited to the doses and indications in this trial. I do share the concerns about the design of the study, but I felt that the results were strong enough that the comparability of these particular drugs was probably shown.”
Panelist: “In terms of the high dropout rate, and the improvement of the visual analog score of only about 10 out of 100, we do a really poor job of controlling our patients’ pain — we see that as rheumatologists and as we continue to move away from opioids, it doesn’t look like nonsteroidals are doing the trick either, so it is something to look at.”
The object of the panel was to say Yes or No, whether Celebrex was comparable to Naproxen and Ibuprofen in the number of people it harmed. It they were all the same, then why not use them! The panel wasn’t trying to find out whether a person was helped until the last panelist mentioned that – oops, the drugs don’t even work to control pain!
Of course, my advice is to saturate yourself with a well-absorbed magnesium and avoid pain and inflammation altogether.
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Carolyn Dean MD ND
The Doctor of the Future®
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