First it was our old friend Vioxx that caused about 140,000 heart attacks in the early 2000s.
As a result, the FDA began warning people about the risk of heart attack and stroke with this class of meds as far back as 2005.
Still further, it seems biotech researchers suspected those risks for as-long-as 15 years; at least in high-dose cases.
Well Now: The FDA is putting its foot down still further and ramping up warnings on even garden variety, similar-class NSAID Painkillers like Ibuprofen, Naproxen & Celebrex. (but not including Aspirin or Tylenol)
And usually when these types of changes come through, they’re not as a result of overcautiousness, but a long considered look at real clinical data.
What those studies showed was that depending on the drug, dosage, and other factors, a person’s risk of having a heart attack or stroke was increased anywhere from 10% to 50%.
Because of those results, there will be mandatory changes in the packet warning language in the near future that will reflect at least the following:
- NSAID painkillers -Do- cause an increased risk of heart attack, failure, and stroke. The term, “May” will be removed from this stipulation.
- The risks are present even for people who have never had heart disease at all.
- The risks can occur as early as the first few weeks of use, and there is no period of use without risk.
- -However, the risks do seem to be greater with longer use, and larger doses.
- The greatest risk is to people who have already had a heart attack or stroke.
- Patients who were treated with [non-aspirin] NSAIDs after their first heart attack or stroke were more likely to die than those not treated with them.
- Patients who need NSAIDs should attempt to take the smallest effective dose for the shortest duration possible.
The FDA also advises to stop taking NSAIDs and seek medical help if you experience symptoms that might signal heart problems or stroke, such as chest pain, trouble breathing, sudden weakness in one part or side of the body, or sudden slurred speech.
So hit up The Links, including the excellent suggestions at Harvard Health, for further technical details and explanations.
And obviously, if you need these drugs, please consult your doctor before making any changes whatsoever.
Photo Credits:”Heart in Hands”, by Chelsee Tysoe
• Source: FDA Drug Safety Communication
• via: Harvard Health
• More Coverage: CNBC | NYDailyNews | NPR
• Ongoing Trial: Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen (PRECISION)
• Source Study: Lancet-Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials