The label includes a Boxed Warning describing the risk of hepatotoxicity associated with APAP. Most cases of liver injury were associated with APAP doses >4000mg daily and often involved >1 APAP-containing product.
All articles by Da Hee Han, PharmD
Several clinical trials have demonstrated the SPRINT PNS System to be effective in reducing pain and improving quality of life.
Lucemyra is not indicated as a treatment for opioid use disorder.
In June 2018, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee met and voted against (14-3) the approval of Remoxy upon data review.
Pending approval, CAM2038 may be the first long-acting treatment for OUD in both weekly and monthly formulations.
The recall affects approximately 470,000 units that include drugs packaged with 3 to 10 tablets per blister card. The blister packs were developed for use in hospitals, however some were sent to retail pharmacies and were likely dispensed for in-home use.
Remoxy ER contains oxycodone, a full opioid agonist, and utilizes the Company’s ORADUR technology which is designed to deter abuse via non-oral routes.
Mirtazapine is a central alpha-2 antagonist currently FDA-approved for the treatment of major depressive disorder.
Consensi combines amlodipine besylate, a calcium-channel blocker (CCB), and celecoxib, a nonsteroidal anti-inflammatory drug (NSAID).
Lucemyra, a selective alpha 2-adrenergic receptor agonist, works by reducing the release of norepinephrine and decreasing sympathetic tone.