January - March 2024 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
[Formerly FDA Adverse Event Reporting System (FAERS)]
The drug product(s) included in any of the potential signals of serious risks/new safety information listed below may also include the generic version of the drug product(s), if there are generic versions approved for use by the FDA at the time of this publication.
| Product Name: Trade (Active Ingredient) or Product Class | Potential Signal of a Serious Risk / New Safety Information | Additional Information (as of June 21, 2024) |
|---|---|---|
Akeega (niraparib and abiraterone acetate) Zejula (niraparib) | Haemorrhage | FDA is evaluating the need for regulatory action. |
Certain amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate (generic product)
| Lack of efficacy/effect | FDA is evaluating the need for regulatory action. |
Calcitonin gene-related peptide (CGRP) inhibitors
| Hypertension | FDA is evaluating the need for regulatory action. |
Certain ertapenem injection (generic product) Certain meropenem injection (generic product) | Wrong drug errors related to look alike labeling | The color scheme for ertapenem container labels and carton labeling was revised in June 2024 to help differentiate the products.
|
| Cotellic (cobimetinib) | Colitis | FDA is evaluating the need for regulatory action. |
Doxycycline containing products
| Psychiatric disorders | FDA is evaluating the need for regulatory action. |
| ELEVIDYS (delandistrogene moxeparvovec-rokl) | Hypersensitivity including anaphylaxis
| The “Warnings and Precautions,” “Postmarketing Experience,” and “Patient Counseling Information” sections of the labeling for Elevidys were updated in June 2024 to include Infusion-related Reactions. |
Gabapentinoids
| Withdrawal syndrome | FDA is evaluating the need for regulatory action. |
Gadolinium-based contrast agents
| Acute respiratory distress syndrome | FDA is evaluating the need for regulatory action. |
Glucagon-like peptide-1 (GLP-1) receptor agonists
| Dysaesthesia | FDA is evaluating the need for regulatory action. |
Gocovri (amantadine) Osmolex ER (amantadine)
| Corneal oedema | FDA is evaluating the need for regulatory action. |
Gonadotropin-releasing hormone (GnRH) agonists
| Severe cutaneous adverse reactions | FDA is evaluating the need for regulatory action. |
Human growth hormone products
| Osteonecrosis | FDA is evaluating the need for regulatory action. |
| Humatrope (somatropin) | Wrong dose errors related to pen and cartridge mismatch | FDA is evaluating the need for regulatory action. |
Intravenous lipid emulsions (IVLEs)
| Anaphylactic reaction | FDA is evaluating the need for regulatory action. |
Kalydeco (ivacaftor) Orkambi (lumacaftor and ivacaftor) Symdeko (tezacaftor and ivacaftor) Trikafta (elexacaftor, tezacaftor, and ivacaftor)
| Psychiatric disorders | FDA is evaluating the need for regulatory action. |
| Krazati (adagrasib) | Toxic epidermal necrolysis | FDA is evaluating the need for regulatory action. |
Lemtrada (alemtuzumab)
| Colitis | The “Warnings and Precautions” section of the labeling was updated in May 2024 to include the risk of immune-mediated colitis.
|
| Leqvio (inclisiran) | Hypersensitivity | The “Contraindications” and “Adverse Reactions” sections of the labeling were updated in June 2024 to include the risk of hypersensitivity.
|
| Lybalvi (olanzapine and samidorphan) | Drug-drug interaction | FDA is evaluating the need for regulatory action. |
Mavenclad (cladribine)
| Drug-induced liver injury | FDA is evaluating the need for regulatory action. |
Norepinephrine reuptake inhibitors (NRIs)
| Withdrawal syndrome | FDA is evaluating the need for regulatory action. |
Certain prasugrel (generic product) Certain pimavanserin tartrate (generic product) | Wrong drug errors related to product dosage form identification | The code imprint for prasugrel was revised in March 2024 to help differentiate the dosage forms.
|
Sphingosine 1-phosphate (S1P) receptor modulators
| Macular oedema | The “Warnings and Precautions” section of the labeling was updated in June 2024 to include the risk of macular edema. Example: Gilenya labeling
|
Sphingosine 1-phosphate (S1P) receptor modulators
| Skin cancer | The “Warnings and Precautions” section of the labeling was updated in June 2024 to include the risk of cutaneous malignancy. Example: Gilenya labeling |
Technetium diphosphonates
| Drug interaction | FDA is evaluating the need for regulatory action. |
| Tecvayli (teclistamab-cqyv) | Tumour lysis syndrome | FDA is evaluating the need for regulatory action. |
| Tetracyclines | Fixed drug eruption | FDA is evaluating the need for regulatory action. |
| Transderm Scop (scopolamine transdermal system) | Hyperthermia | FDA is evaluating the need for regulatory action. |
| Zelboraf (vemurafenib) | Colitis | FDA is evaluating the need for regulatory action. |