The FDA strengthened warnings on over-the-counter and prescriptions painkillers known as nonsteroidal anti-inflammatory drugs (NSAIDs). This class of painkillers can cause serious, life-threatening cardiovascular events and are available in hundreds of forms, from Advil to Daypro. Our team of dangerous drug lawyers report on this new warning below.
The cardiovascular risks of NSAIDs have been known for 15 years, however, it was believed heart disease and stroke could only occur in people who took extremely high doses. Now, the FDA has updated drug labels to warn:
- Heart attack or stroke can occur as early as the first week of NSAID use.
- NSAIDs can increase the risk of heart attack or stroke in people without heart disease or other cardiovascular risk factors.
- Those with, or at risk of, heart disease are at a greater risk of heart attack or stroke.
- It is not clear if the risk is the same for all NSAIDs.
- NSAIDs also present an increased risk of heart failure.
- The risks are higher at higher doses and with longer use.
The medical industry has been concerned about NSAID safety for quite some time. In 2007, the American Heart Association urged clinicians to use the lowest dose possible and for the shortest time needed in patients. In 2011, a coalition was established to raise awareness of the severe risks associated with these drugs, the Alliance for Rational Use of NSAIDs.
In 2013, a medical journal reported that high doses of popular NSAIDs increased the risk of vascular events by one third. The main outcomes in that study were heart attack, stroke, vascular death, heart failure, upper gastrointestinal complications, and major coronary events. The study found that heart failure risk was doubled by all NSAIDs, and all NSAIDs increased the risk of upper gastrointestinal complications.
Antidepressants + NSAIDs = Brain Bleeds
Another medical journal recently published a study finding that the risk of brain bleeds is increased when a patient combines antidepressants with NSAIDs. This study analyzed only prescription NSAIDs, like Daypro, Celebrex, or Toradol.
People who suffer from depression also often suffer from chronic pain. In this study, patients who took both an antidepressant and an NSAID had a 60% greater risk of brain bleeds than patients only taking an antidepressant. The risk was particularly prevalent in men.
Why exactly this mix of prescriptions increased the possibility of brain bleeds remains to be proven. The researchers noted that both NSAIDs and antidepressants inhibit platelets and increase the risk of gastrointestinal bleeding.
NSAIDs that are available over-the-counter include Advil, Aleve, Motrin, Bayer, Ecotrin, Ascriptin, and the generics ibuprofen, aspirin, and naproxen. There are many NSAIDs available by prescription. A full list can be found here.
The dangerous drug attorneys at Pintas & Mullins Law Firm have been fighting on behalf of people injured by pharmaceuticals for 30 years. We have extensive experience and a wide network of legal and medical professionals that ensures our clients receive the best possible counsel and outcome. Our lawyers and paralegals offer free case reviews and we accept clients nationwide.