Drug labels need to depict the names of their contents satisfactorily on behalf of the consumer.
Pharmaceutical regulations are among the strictest compliance requirements found in North America, even those that govern the use, sale, packaging and labeling of drugs that can be sold over the counter at common pharmacies. Safety notices hold a special position as some of the most important guidelines among all of these. As such, the recently announced adjustment that Celebrex (celecoxib in generic form) packaging coming off of drug companies’ label printers must now reflect findings proving the drug to have fewer side effects than once believed constitutes a major change for the industry.
Celebrex side effects are now thought to be no stronger than those of ibuprofen.
Non-steroidal anti-inflammatory drugs, such as ibuprofen, aspirin and naproxen, can be bought just about anywhere, and are perhaps the most commonly used over-the-counter pain relief medicines. Celecoxib counts among these, but in the past, this NSAID was considered slightly more risky than its counterparts.
All drugs in this group can cause stomach bleeding (or aggravate existing ulcers), especially if taken by those who regularly drink alcohol more than the average North American. The belief of celecoxib’s elevated danger stemmed from concerns regarding its effects on cardiovascular health.
According to Regulatory Focus, a study to determine the exact cardiovascular risk of celecoxib began in 2006, and its results weren’t publicized until December 2016. Called “Prospective Randomized Evaluation of Celecoxib Integrated Safety vs Ibuprofen or Naproxen” (PRECISION), it began in response to wariness over the drug’s heart health risks, which had been posed by the Food and Drug Administration.
Over the course of the next eight years, the research initiative collected usable data from 24,081 patients in 13 different countries across the world. Per the finalized study as it was published in the New England Journal of Medicine, three approximately equal groups were formed: one given celecoxib, one receiving ibuprofen and the final group was administered naproxen. Celecoxib went out in its lowest approved dose of 100 milligrams, while naproxen patients received between 375 and 500 mg twice daily and members of the ibuprofen group received 600-800 mg three times a day.
The trial determined definitively that the safety risk for all three drugs was approximately equivalent, when taken at common levels of daily dosage. Members of the group that took celecoxib saw a lower rate of hospitalization for hypertension than those in the two controls, and the number of other significant cardiovascular events was also lower. Study authors did acknowledge one potential blind spot in their study: there had not been enough major adverse cardiac events during the course of the study to form a meaningful enough sample size. As a result, even though the celecoxib group also experienced these emergencies less often than those on ibuprofen and naproxen, that particular data set couldn’t be relied upon.
Nevertheless, it was enough for the FDA to change its position on celecoxib, as announced in a press release:
“Postmarketing safety studies such as the PRECISION trial can add valuable information to our understanding of drug safety issues that emerge in the postmarketing period, and we provide this information to give health care providers a better understanding of the NSAIDs’ drug safety profile,” the agency stated.
To solidify this adjustment of its belief, the FDA approved the addition of a new label to celecoxib in its Pfizer-branded Celebrex form explaining the results of the clinical trial. Changes to the warnings on generic supplies of the drug will likely soon follow.