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

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.
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