Federal health officials will next week allow all adults to begin receiving Pfizer’s arthritis drug Xeljanz, the Wall Street Journal reported, as an alternative to first-line treatment methotrexate. Under the new rules, an estimated 10 million patients may be eligible to get the drug. This marks a major regulatory shift: Xeljanz was only approved in 2014 for use in pediatric patients.
The decision comes on the heels of what could be a sea change in the scope of use of prescription medications, with companies pushing pills as therapies to offer additional pain-control or, in many cases, even help the mind — adding a regimen of drugs to supplement multiple pills of a standard medication, which can in itself help maintain health and alleviate long-term pain.
The FDA has also deemed drugs’ addiction potential to be a fact of life, and has run safety trials of drug cocktails. To tackle the opioid addiction crisis, state officials in 2017 proposed a limit on opioid prescriptions, depending on the patient, doctor and duration of the hospital stay, including the option of limits and “physician error” or “doctor shopping” for narcotics.
The new FDA directives may come as a disappointment to some clinicians, who requested more flexibility in dosing in the agency’s most recent approval proposal, in which the regulator said that preventing overdose was “a primary goal,” so that dosage could be adjusted before patients overdose from their medications.
Two brands of Xeljanz — generic and brand-name — have already been approved for use in adults and may continue to be marketed by current distributors. This new range of approvals is set to go into effect on Wednesday, the Journal reported.