The findings of new research suggests that heart risks associated with the side effects of Celebrex when used for treatment of arthritis are similar those seen with other popular pain medications, including Aleve, Motrin and Advil.
In a study published this week in the The New England Journal of Medicine, researchers from the Cleveland Clinic found that while common nonsteroidal anti-inflammatory drugs (NSAIDs) drugs may not be overly dangerous to patients in moderate doses, all three medications increased the risk of heart problems when taken in high doses over a long period of time.
Researchers evaluated data involving more than 24,000 patients who used NSAIDs for osteoarthritis or rheumatoid arthritis. They were randomly assigned to either Celebrex (celecoxib), Aleve (naproxen) or ibuprofen, which is sold under the brand names Advil and Motrin., and were scheduled to take consistent doses of the medications for 20 months and followed up with after 34 months.
Patients taking Advil or Motrin were given 600 mg three times a day, which is a relatively high dose. The package dosing is 200 mg, or one tablet. However, many people taking Advil for pain will take two tablets several times a day. Aleve patients received 375 mg twice a day and Celebrex patients received 100 mg twice a day.
Overall, researchers said 69% of patients stopped taking the drug assigned to them and 27% discontinued followups.
All three drugs caused heart problems. Heart attacks or strokes occurred in 2.3% of patients using Celebrex. Similarly, 2.5% of Aleve patients and 2.7% of Advil/Motrin patients had heart attacks or strokes while on the medications.
In 2014, an FDA advisory panel called for Aleve to carry strong warnings concerning heart risks to patients. A study also published that year indicated people taking Advil and Motrin had an 84% increased risk of developing abnormal heart rhythm, or atrial fibrillation.
NSAID Side Effects
Celebrex had a lower risk of hospitalization for high blood pressure when compared to Aleve, Advil and Motrin. It also carried a lower risk of kidney problems when compared to Advil, but not Aleve.
The patients were also given the stomach drug Nexium, to prevent stomach bleeds, which has been a problem associated with NSAIDs. The risk of bleeding was lower with Celebrex.
Researchers say the findings of the study apply to patients who are taking high doses or consistent doses over time. Study authors say patients taking those drugs for a simple headache or intermittent pain shouldn’t worry about the long term effects. The risks mainly apply to those using the medications consistently.
However, even occasional use should be limited. Doctors always recommend to take the lowest effective dose possible for the shortest amount of time needed to prevent long term damage, such as heart attack, stroke or stomach bleed.
Another arthritis drug was pulled from the market after concerns of serious side effects were raised. In 2004, reports of Vioxx linked to heart attacks and other heart deaths were reported. The drug was originally approved in 1999 as a painkiller in the same class as Tylenol and Advil.
In 2011, Merck settled a lawsuit with the federal government by paying $950 million concerning off-label marketing and prescribing that led to widespread health problems.
Concerns regarding Celebrex heart problems were raised more than 10 years ago, prompting the FDA to issue a black box warning for the drug. A black box warning is a warning the FDA requires manufacturers to place on a medication packaging to call attention the the possible risks and side effects.
The NSAID market is a lucrative business. In the U.S. Americans spent $1 trillion in 2015 for Celebrex, Aleve, Motrin and Advil. This was a drop from $2.8 trillion in 2014.