Common Drugs: Celebrex, Advil, Motrin, Aleve Gain Serous New FDA Warnings on Heart Attack & Stroke

NSAIDs Warnings: “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”

The warning about using NSAIDs with antidepressants came out long ago. When taken together the combination can cause gastrointestinal bleeding.

Which common drugs are we talking about? From the FDA website: “Common OTC NSAIDs include ibuprofen (Motrin, Advil) and naproxen (Aleve). In addition, some combination medicines that relieve various symptoms, such as multi-symptom cold products, contain NSAIDs.”

Just last month the FDA issued new even stronger Black Box Warnings on these drugs used daily by most everyone. They are very serious warnings, so much so that since they have made little headline news I want to make sure you are all aware of this. Such strong warnings are these additions to their Black Box Warning that we have articles with titles as, “Picked Out a Coffin Yet? Take Ibuprofen and Die” Please do not miss a word of this post!

Most Vulnerable & Deadly Period of Prescription Use for Patients

Why isn’t this headline news when 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. But what is new? This is the main reason we formed the International Coalition for Drug Awareness ( two decades ago as stated in our mission statement. We send out warnings like this during the most vulnerable period for patients – between when the FDA issues approval until the warnings and withdrawing from the market comes on prescription drugs.

Note this statement by the doctor whose study got the NSAIDs Vioxx pulled closely followed by the removal of the NSAID Bextra: “Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, agrees with the evidence that these drugs do increase a person’s risk for heart attack and stroke. He says the warning, though is vague but has to be because there is no good data to give consumers or doctors a definitive answer.

“What patients need to know is, if you take the drugs, ‘What is my risk of heart attack?’ and that’s not known yet,” Nissen says. He blames this on the drugs being approved before current vigorous outcome data was required by the FDA.

“Nissen told CNN, “the writing has been on the wall for a long time.” After all, he is no stranger to these concerns. His 2001 study was the first to raise a red flag over the drug Vioxx, a COX-2 inhibitor, made by Merck, that was pulled from the market. On the heels of that, another COX-2 inhibitor, Bextra, was withdrawn.”

The FDA has known for years that taking popular nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin, Advil), Aleve, and Celebrex may be dangerous for your heart. It was a decade ago, in 2005, when the agency first warned that taking NASIDs increases your risk of heart attack or stroke, either of which can be fatal.

Of course that warning did not come until after Vioxx, also an NSAID, caused up to 140,000 heart attacks in the five-year period it was on the market (it was pulled from the market in 2004).

Now Serious Black Box Warnings on NSAIDs

“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.”

– FDA website (See specific warnings below)

Everyone needs to understand if a drug is in a class of drugs like Vioxx was with all these other NSAIDs they work the same way, therefore, they are capable of producing similar results in the way of adverse effects. So when one is pulled from the market all of them really SHOULD also be pulled. Why do we wait for years for these warnings?!! I have been issuing this warning from the day the information came out on Vioxx. What is that saying? Stupidity is doing the same thing over and over again and expecting a different result?

In light of that information about drugs in the same class should all have the same warning I thought this statement from the FDA website about asprin was very interesting: “(Although aspirin is also an NSAID, this revised warning doesn’t apply to aspirin.)” For me that would mean the same warning should apply just as this warning should have come out for all NSAIDs back when Vioxx was pulled instead of waiting another decade to issue this warning for all the others. But because doctors have been telling people for years to take asprin to prevent heart attacks, they may be worried about the backlash of wrongful death suits that may follow if they include asprin. All I can say is that after this warning I am just really grateful that somehow at age 18 I knew enough to stop the use of asprin or anything like it! This makes me extremely grateful for my knowledge of herbs and essential oils and other alternative treatments.


So the heart warning was already included in the Black Box Warning for these drugs, but because they are so widely used, and because of the new review, the FDA, has finally strengthened the warning.

The new warning was recommended after reviewing safety information on both prescription and over-the-counter (OTC) NSAIDs, including observational studies, a large combined analysis of clinical trials, and additional scientific publications.

The FDA’s New Black Box Warning Includes:

#1 Your risk of heart attack or stroke may increase as early as the first weeks of using an NSAID .

#2 Your risk may increase the longer you use the NSAID.

#3 The risk appears greater at higher doses.

#4 NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease.

#5 Patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.

#6 Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.

#7 There is an increased risk of heart failure with NSAID use.

#8 The FDA stressed that patient and doctor alike should “remain alert for heart-related side effects” the entire time NSAIDs are being taken.

#9 They can occur after just a couple of weeks of use and even if you’re healthy and have no risk factors for heart disease

But that is not all….

Not just heart risks, but ulcers and perferation of stomach or intestines

NSAIDs, including even OTC options like aspirin, are notorious for being hard on your gastrointestinal tract, leading to potentially fatal side effects such as bleeding in your digestive tract, ulcers and perforation of your stomach or intestines! In fact asprin is known to cause as many deaths each year as AIDs.

Commonly Prescribed for Joint Pain, Yet May Destroy Carlilage & Joints

Although NSAIDs are one of the most common drug classes used to treat joint pain, they may actually disrupt cartilage synthesis and actually speed up the destruction of your cartilage and joints.


Picked Out a Coffin Yet? Take Ibuprofen and Die

FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs

FDA Adds Heart Attack And Stroke Warning To Some Painkillers


Ann Blake Tracy, Executive Director,

International Coalition for Drug Awareness & ssristories.NET
Author: ”Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

WITHDRAWAL WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

WITHDRAWAL HELP: You can find the hour and a half long CD on safe and effective withdrawal helps here: And if you need additional consultations with Ann Blake-Tracy, you can book one or sign up for one of the memberships in the International Coalition for Drug Awareness which includes free consultations as one of the benefits of that particular membership plan. For only a $30 membership for one month you can even get 30 days of access to the withdrawal CD with tips on rebuilding after the meds, all six of my DVDs, hundreds of radio interviews, lectures, TV interviews I have done over the years PLUS access to my book on antidepressants (500 plus pages) with more information than you will find anywhere else (that is only $5 more than the book alone would cost) (Definitely the best option to save outrageous postage charges for those out of the country!)

Leave a Reply