The FDA’s Bland Perspective on the Cardiovascular Dangers of Nonsteroidal Anti-inflammatory Drugs (NSAIDs) — and My Observation regarding How to Protect Yourself

© 2015 Peter Free

 

27 July 2015

 

 

Can y’all be good?

 

In July this year, the Food and Drug Administration did its customary plutocrat-supporting job with respect to the cardiac danger that NSAIDs pose:

 

 

Next time you reach into the medicine cabinet seeking relief for a headache, backache or arthritis, be aware of important safety information for non-steroidal anti-inflammatory drugs.

 

FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of a heart attack or stroke, either of which can lead to death.

 

Those serious side effects can occur as early as the first few weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (Although aspirin is also an NSAID, this revised warning doesn’t apply to aspirin.)

 

The labels for both prescription NSAIDs and OTC NSAIDs already have information on heart attack and stroke risk.

 

In the coming months, FDA will require manufacturers of prescription NSAIDs to update their labels with more specific information about heart attack and stroke risks. FDA will also request that the manufacturers of OTC NSAIDs update the heart attack and stroke risk information in Drug Facts labels.

 

FDA added a boxed warning to prescription drug labels for this risk in 2005. More recent data and information are prompting FDA to update NSAID labeling. Today we know that the risk of heart attack and stroke may occur early in treatment, even in the first weeks.

 

“There is no period of use shown to be without risk,” says Judy Racoosin, M.D., M.P.H., deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products.

 

© 2015 Food and Drug Administration, FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs, FDA.gov (21 July 2015) (extracts, underline added)

 

 

The FDA will “ask” — Sounds comforting, no?

 

Mike Whitney took a legitimately outraged slant on the FDA’s pusillanimity:

 

 

In case you missed it: The FDA has just issued a warning on various prescription and non-prescription drugs that Americans ingest by the boatload. As it happens, these seemingly benign pain relievers can kill you even if you scrupulously follow the recommended dosage.

 

Why isn’t this headline news?

 

People take tons of these chemicals everyday thinking they’ve been thoroughly tested and are totally safe. Now we find out that’s not the case. Now we discover that you can get a heart attack or stroke “as early as the first few weeks of using” them. Doesn’t that come as a bit of a shock to you, dear reader? Doesn’t that make you suspect that the FDA is not telling the whole truth here, but is simply covering up for a profit-obsessed industry that doesn’t give a rip about its customers health?

 

[K]eep in mind, (according to [Fred] Gardner) Vioxx killed over 165,000 people.

 

Now guess how many Merck executives went to jail?

 

Yep. Zero.

 

The FDA knows that these anti inflammatories are killing people and they’re going to “ask” the drug companies if they’ll change the labels?

 

Is this how regulation works in the US nowadays; the agencies basically have to grovel before these cutthroat industries just to get them to do the right thing?

 

© 2015 Mike Whitney, Picked Out a Coffin Yet? Take Ibuprofen and Die, CounterPunch (24 July 2015)

 

 

You may be surprised what physicians do not know about NSAIDs

 

More than two years ago, I was concerned enough — based on my medical training and litigation experience — to write an article demonstrating that NSAIDs appear to vary in their potentials for cardiac toxicity. Physicians around the world were still regularly prescribing the most dangerous NSAIDs instead of the least.

 

I doubt that this has changed. If you are taking NSAIDs, read the article. Then talk to your doc. Unlike the FDA, she and he actually are on your side.

 

As a matter of sane governance, one can legitimately wonder why the FDA — and Congress via enabling legislation — have made no effort to distinguish the potential lethality of one NSAID from another.

 

Physicians have far too much to do to sort through literature that regulatory agencies should be seeking — or insisting be generated — on their behalf.

 

 

The moral? — If there is corporate money to be made, captured regulatory agencies do not look out for our interests

 

In the United States’ now predominantly non-regulatory form of capitalism — pretense, deception and camouflage reign.