January – March 2023 | Potential Signals of Serious Risks/New Safety I

Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) Weight increased

The “Adverse Reactions” section of the labeling was updated in February 2024 to include weight increased.

 Biktarvy labeling

Braftovi (encorafenib)

Tafinlar (dabrafenib)

Photosensitivity reaction

The “Adverse Reactions” section of the labeling was updated between February 2024 and September 2024 to include photosensitivity.

Example: Tafinlar labeling

Brukinsa (zanubrutinib)

Calquence (acalabrutinib)

Imbruvica (ibrutinib)

Jaypirca (pirtobrutinib)

Drug-induced liver injury

The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated between May 2024 and June 2024 to include information about drug-induced liver injury.

Example: Imbruvica labeling

Entyvio (vedolizumab)

Tysabri (natalizumab)

Interstitial lung disease

The “Adverse Reactions” section of the labeling for Entyvio was updated in April 2024 to include interstitial lung disease.

Entyvio labeling

FDA determined that no action was necessary for Tysabri at the time based on available information.

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)

Hydrea (hydroxyurea)*

 

Drug-device interaction

The “Warnings and Precautions”, “Drug Interactions”, “Medication Guide”, and “Patient Counseling Information” sections of the labeling were updated in November 2023 to include information about drug-device interaction.

Example: Siklos labeling

* An administrative error resulted in the omission of Hydrea from the list of product names and was added after the initial quarterly report was posted.

Iclusig (ponatinib)

Scemblix (asciminib)

 

Panniculitis

The “Adverse Reactions” section of the labeling was updated in March 2024 to include panniculitis.

Iclusig labeling

FDA determined that no action was necessary for Scemblix at the time based on available information.

Kineret (anakinra) Amyloidosis

The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in October 2025 to include information about amyloidosis.

Kineret labeling

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) Infections and infestations

The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in February 2024 to include information about infections.

Mavenclad labeling

Mekinist (trametinib)

Mektovi (binimetinib)

Photosensitivity reaction

The “Adverse Reactions” section of the labeling was updated between February 2024 and September 2024 to include information about photosensitivity.

Example: Mektovi labeling

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)

Nexlizet (bempedoic acid and ezetimibe) *

 

Hypersensitivity

The “Adverse Reactions” section of the labeling was updated in September 2023 to include information about hypersensitivity.

Example: Nexletol labeling

*An administrative error resulted in the omission of Nexlizet from the list of product names and was added after the initial quarterly report was posted.

Norepinephrine Bitartrate in Dextrose Injection Product label confusion contributing to medication error

The container and overwrap labels were revised in November 2023 to mitigate the potential for medication errors.

Norepinephrine Bitartrate in Dextrose labeling

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)

• Flowtuss (hydrocodone and guaifenesin)*
• Hycodan (hydrocodone bitartrate and homatropine methylbromide)*
• Hycofenix (hydrocodone, pseudoephedrine, and guaifenesin)*
• Obredon (hydrocodone bitartrate and guaifenesin)*
• Promethazine HCl and Codeine Phosphate*
• Promethazine HCl, Phenylephrine HCl, and Codeine Phosphate*
• Tuxarin ER (chlorpheniramine maleate and codeine phosphate)*
• Tuzistra XR (chlorpheniramine and codeine)* 
• Xtrelus (hydrocodone bitrate and guaifenesin)*

Hypoglycemia

The “Adverse Reactions” and “Overdosage” sections of the labeling were updated in December 2023 to include information about hypoglycemia.

Example: Oxycontin labeling

Additional information is not provided for Fiorinal with Codeine and Kadian because approval of the marketing applications for these products was withdrawn by FDA, at the applicant’s request, prior to the labeling updates referenced above.

* FDA updated this signal for Hypoglycemia to include the products Flowtuss, Hycodan, Hycofenix, Obredon, Promethazine HCl and Codeine Phosphate, Promethazine HCl Phenylephrine HCl and Codeine Phosphate, Tuxarin ER, Tuzistra XR, and Xtrelus after the initial quarterly report was posted.

Recothrom (thrombin topical recombinant) Thrombosis due to inadvertent IV administration

The “Warnings and Precautions” section of the labeling was updated in January 2024 to include information about the risk of thrombosis due to inadvertent IV administration.

Recothrom labeling

A warning that Recothrom is for topical use only was added to the syringes packaged with Recothrom in July 2024 to mitigate the risk of inadvertent IV administration.

Tepezza (teprotumumab-trbw) Hearing impairment

The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in July 2023 to include information about hearing impairment.

Tepezza labeling

Turalio (pexidartinib) Diarrhea

FDA determined that no action was necessary at the time based on available information. 

Turalio (pexidartinib) Photosensitivity reaction

The “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in November 2023 to include information about photosensitivity reaction.

Turalio labeling 

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