January - March 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Product Name: Trade (Active Ingredient) or Product Class	Potential Signal of a Serious Risk / New Safety Information	Additional Information (as of June 16, 2023)
Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)	Weight increased	FDA is evaluating the need for regulatory action.
Braftovi (encorafenib) Tafinlar (dabrafenib)	Photosensitivity reaction	FDA is evaluating the need for regulatory action.
Brukinsa (zanubrutinib) Calquence (acalabrutinib) Imbruvica (ibrutinib) Jaypirca (pirtobrutinib)	Drug-induced liver injury	FDA is evaluating the need for regulatory action.
Entyvio (vedolizumab) Tysabri (natalizumab)	Interstitial lung disease	FDA is evaluating the need for regulatory action.
Delsam Pharma’s Artificial Eye Ointment EzriCare Artificial Tears	Product contamination microbial	Global Pharma Healthcare Issues Voluntary Recall of Delsam Pharma Artificial Eye Ointment on February 24, 2023 Safety Alert:  FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination
Droxia (hydroxyurea) Siklos (hydroxyurea) Generic products containing hydroxyurea	Drug-device interaction	FDA is evaluating the need for regulatory action.
Iclusig (ponatinib) Scemblix (asciminib)	Panniculitis	FDA is evaluating the need for regulatory action.
Kineret (anakinra)	Amyloidosis	FDA is evaluating the need for regulatory action.
Local anesthetics Carbocaine (mepivacaine hydrochloride) Prilocaine hydrochloride 4% with epinephrine 1:200,000 injection 4% Citanest Plain Dental (prilocaine hydrochloride injection) Clorotekal (chloroprocaine hydrochloride) Emla Cream (lidocaine 2.5% and prilocaine 2.5%) Exparel (bupivacaine liposome injectable suspension) Goprelto (cocaine hydrochloride) Kovanaze (oxymetazoline hydrochloride and tetracaine hydrochloride) Lidoderm (lidocaine patch 5%) Marcaine Hydrochloride (bupivacaine hydrochloride) Naropin (ropivacaine hydrochloride) Nesacain (chloroprocaine hydrochloride injection) Numbrino (cocaine hydrochloride) Orabloc (articaine hydrochloride and epinephrine) Oraqix (lidocaine and prilocaine periodontal gel) Pliaglis (lidocaine and tetracaine) Posimir (bupivacaine solution) Sensorcaine (bupivacaine hydrochloride) Sensorcaine with epinephrine (bupivacaine hydrochloride and epinephrine) Septocaine (articaine hydrochloride and epinephrine injection) Synera (lidocaine and tetracaine) Xaracoll (bupivacaine hydrochloride) Xylocaine Dental (lidocaine hydrochloride injection) Xylocaine (lidocaine hydrochloride and epinephrine injection) Zingo (lidocaine hydrochloride monohydrate) Zynrelef (bupivacaine and meloxicam) Ztlido (lidocaine topical system)	Hepatic enzymes and function abnormalities	FDA is evaluating the need for regulatory action.
Mavenclad (cladribine) Generic products containing cladribine	Infections and infestations	FDA is evaluating the need for regulatory action.
Mekinist (trametinib) Mektovi (binimetinib)	Photosensitivity reaction	FDA is evaluating the need for regulatory action.
Diskets (methadone hydrochloride) Methadone Hydrochloride Methadose (methadone hydrochloride)	Accidental exposure to product by child	FDA is evaluating the need for regulatory action.
Nexletol (bempedoic acid)	Hypersensitivity	FDA is evaluating the need for regulatory action.
Norepinephrine Bitartrate in Dextrose Injection	Product label confusion contributing to medication error	FDA is evaluating the need for regulatory action.
Opioids Actiq (fentanyl citrate) Alfentanil Hydrochloride Injection Apadaz (benzhydrocodone and acetaminophen) Belbuca (buprenorphine buccal film) Buprenex (buprenorphine hydrochloride) Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules Butrans (buprenorphine) Cassipa (buprenorphine and naloxone) Codeine Sulfate Oral Solution Codeine Sulfate Tablets Demerol (meperidine hydrochloride) Dilaudid (hydromorphone hydrochloride) Dsuvia (sufentanil) Duramorph (morphine sulfate) Fentanyl Citrate Injection Fentora (fentanyl buccal tablet) Fiorinal with Codeine (butalbital, aspirin, caffeine and codeine phosphate) Hydromorphone Hydrochloride Injection Hysingla ER (hydrocodone bitartrate) Kadian (morphine sulfate) Infumorph (morphine sulfate) Mepergan (meperidine hydrochloride and promethazine hydrochloride) Morphine Sulfate Injection Morphine Sulfate Oral Solution Morphine Sulfate Tablets MS Contin (morphine sulfate extended release) Nubain (nalbuphine hydrochloride) Nucynta (tapentadol) Nucynta ER (tapentadol) Olinvyk (oliceridine) Opana ER (oxymorphone hydrochloride) Oxaydo (oxycodone hydrochloride) Oxycodone Hydrochloride Capsules Oxycodone Hydrochloride Oral Solution Oxycontin (oxycodone hydrochloride) Percodan (oxycodone and aspirin) Probuphine (buprenorphine) Roxicodone (oxycodone hydrochloride) Roxybond (oxycodone hydrochloride) Sublocade (buprenorphine extended release) Suboxone (buprenorphine and naloxone) Sufentanil Citrate Injection Synalgos-DC (aspirin, caffeine, and dihydrocodeine bitartrate) Ultiva (remifentanil hydrochloride) Xtampza ER (oxycodone) Zubsolv (buprenorphine and naloxone sublingual tablets)	Hypoglycaemia	FDA is evaluating the need for regulatory action.
Recothrom (thrombin topical recombinant)	Thrombosis due to inadvertent IV administration	FDA is evaluating the need for regulatory action.
Tepezza (teprotumumab-trbw)	Hearing impairment	FDA is evaluating the need for regulatory action.
Turalio (pexidartinib)	Diarrhoea	FDA is evaluating the need for regulatory action.
Turalio (pexidartinib)	Photosensitivity reaction	FDA is evaluating the need for regulatory action.