January - March 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)
Generic products containing 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)
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
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.
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