FDA update - NSAIDs and increased risk of heart attack and stroke

In case you missed the recent headlines:


FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

[ 7-9-2015 ]

Announcement

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on our comprehensive review of new safety information, we are requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. We will also request updates to the OTC non-aspirin NSAID Drug Facts labels.

Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.

NSAIDs are widely used to treat pain and fever from many different long- and short-term medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. NSAIDs are available by prescription and OTC. Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib (see Table 1 for a list of NSAIDs).

The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Since then, we have reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies,1 a large combined analysis of clinical trials,2 and other scientific publications.1 These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014.

Based on our review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information:

The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.

The risk appears greater at higher doses.

It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.

NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.

In general, 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.
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.

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

We will request similar updates to the existing heart attack and stroke risk information in the Drug Facts labels of OTC non-aspirin NSAIDs.

In addition, the format and language contained throughout the labels of prescription NSAIDs will be updated to reflect the newest information available about the NSAID class.

Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken. We urge you to report side effects involving NSAIDs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

[www.fda.gov]

Thanks Jackie. So, where does that leave patients these days? Tylenol?

Q

Tylenol and aspirin have their own set of problems. Occasional use isn't what's typically found to be harmful... it's the long term and multiple doses a day that cause health issues.

Many natural anti-inflamatories help relieve pain. Best is to correct the source of pain if it's chronic such as arthritis through eliminating what is causing the pain the the first place... typically diet.

I don't have pain issues but if I do need something temporary... Zyflamend is my favorite along with Turmeric or Curcumin (Mervia) is excellent. Bromelain also. Topical Arnica Gel is fast acting as is topical magneisum gel or oil for muscle pain.

I'm a also big fan of Essential Oils of Plants. Lavender and Peppermint are quick and pleasant. Just be sure you use steam distilled sources...from a reputable source. Lots of wannabee brands out there. Young Living is superior.

Jackie

More news on the NSAIDs topic - Medscape report indicates:

Antidepressant/NSAID Combo Linked to Brain Bleed Risk
July 14, 2015
Nancy A. Melville

The combination of antidepressants and nonsteroidal anti-inflammatory drugs (NSAIDS) is linked to an early increased risk for intracranial hemorrhage, regardless of the type of NSAID or antidepressant, new research shows.

"The take-home message for clinicians is that special attention should be paid [to] antidepressant users when they start an NSAID prescription," coauthor Byung-Joo Park, MD, MPH, PhD, told Medscape Medical News.

"Monitoring bleeding risk is particularly needed at the initial combined use of both medicines," added Dr Park, who is a professor in the Seoul National University College of Medicine's Department of Preventive Medicine, in Korea.

The study was published online July 14 in the BMJ.

Increased 30-Day Risk
Continue:
[www.medscape.com]

Thanks Jackie, as always you are treasure trove of resources.

This was a good article I found:

[drjohnday.com]

Thanks, Que, for pursuing this. Definitely a useful report you found. I've sent the link to several who are taking large daily doses of NSAIDs for arthritic pain.

Jackie

You're welcome Jackie.

I'm exploring therapies for my Sleep Apnea, which was recently diagnosed at Stanford and one leading option entails surgery. Apparently it is quite painful for 2 weeks post surgery and the doctor has indicated that he would keep me on pain killers. I believe they would be narcotics/opiates. What is the thinking these days for post-op pain management?

Q