The “Warnings and Precautions,” “Adverse Reactions,” and “Overdosage” sections of the Prescribing Information were updated in November 2024 to describe fatal outcomes associated with acetylcysteine overdosage, including hemolytic uremic syndrome, seizure/cerebral edema, and anaphylaxis.
Aromatase inhibitors
- Arimidex (anastrozole)
- Aromasin (exemestane)
- Femara (letrozole)
The “Adverse Reactions” section of the labeling was updated in December 2024 to include information about tendon disorders.
Example: Aromasin labeling
Avonex (interferon beta-1a)
Betaseron (interferon beta-1b)
Extavia (interferon beta-1b)
Plegridy (peginterferon beta-1a)
Rebif (interferon beta-1a)
Bactrim (sulfamethoxazole and trimethoprim)
Septra (trimethoprim and sulfamethoxazole)
Sulfatrim (sulfamethoxazole and trimethoprim)
Generic products containing sulfamethoxazole and trimethoprim
The “Information for Patients” section of the labeling was updated in June 2024 to include hypersensitivity and other serious reactions and expanded the list of symptoms warranting immediate medical attention.
Example: Bactrim labeling
Bafiertam (monomethyl fumarate)
Tecfidera (dimethyl fumarate)
Vumerity (diroximel fumarate)
Generic products containing dimethyl fumarate, diroximel fumarate or monomethyl fumarate
Bisphosphonates
- Actonel (risedronate sodium)
- Atelvia (risedronate sodium)
- Binosto (alendronate sodium)
- Boniva (ibandronate sodium)
- Fosamax (alendronate sodium)
- Fosamax Plus D (alendronate sodium/cholecalciferol)
- Reclast (zoledronic acid)
Generic products containing bisphosphonates
Brilinta (ticagrelor)
Crestor (rosuvastatin)
Ezallor Sprinkle (rosuvastatin)
Roszet (rosuvastatin and ezetimibe)
The “Drug Interactions” and “Clinical Pharmacology” sections of the labeling were updated between July 2024 and February 2025 to include information about the risk of rhabdomyolysis.
Example: Ezallor Sprinkle labeling
Bylvay (odevixibat)
Livmarli (maralixibat)
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in March 2024 and March 2025 regarding bleeding related to fat-soluble vitamin deficiency.
Example: Bylvay labeling
Calcitonin gene-related peptide receptor antagonists
- Ajovy (fremanezumab-vfrm)
- Aimovig (erenumab-aooe)
- Emgality (galcanezumab-gnlm)
- Nurtec ODT (rimegepant)
- Qulipta (atogepant)
- Ubrelvy (ubrogepant)
- Vyepti (eptinezumab-jjmr)
Cholinesterase inhibitors
- Adlarity (donepezil transdermal system)
- Aricept (donepezil hydrochloride)
- Aricept ODT (donepezil hydrochloride)
- Bloxiverz (neostigmine methylsulfate)
- Enlon-Plus (edrophonium chloride and atropine sulfate)
- Exelon Patch (rivastigmine transdermal system)
- Mestinon (pyridostigmine bromide)
- Namzaric (memantine and donepezil hydrochlorides)
- Neostigmine methylsulfate
- Prevduo (neostigmine methylsulfate and glycopyrrolate)
- Pyridostigmine bromide
- Razadyne ER (galantamine)
- Regonol (pyridostigmine bromide)
- Tensilon (edrophonium chloride)
The “Adverse Reactions” section of the labeling was updated for Exelon Patch in May 2024 to include information about QTc prolongation.
FDA determined that no action was necessary for all other listed products at the time based on available information.
Cholinesterase inhibitors
- Adlarity (donepezil transdermal system)
- Aricept (donepezil hydrochloride)
- Aricept ODT (donepezil hydrochloride)
- Bloxiverz (neostigmine methylsulfate)
- Enlon-Plus (edrophonium chloride and atropine sulfate)
- Exelon Patch (rivastigmine transdermal system)
- Mestinon (pyridostigmine bromide)
- Namzaric (memantine and donepezil hydrochlorides)
- Neostigmine methylsulfate
- Prevduo (neostigmine methylsulfate and glycopyrrolate)
- Pyridostigmine bromide
- Razadyne ER (galantamine)
- Regonol (pyridostigmine bromide)
- Tensilon (edrophonium chloride)
The “Adverse Reactions” section of the labeling was updated for Exelon Patch in May 2024 to include information about torsade de pointes.
FDA determined that no action was necessary for all other listed products at the time based on available information.
Certain fluorouracil product (generic product for the trade name Efudex)
The container labels and carton labeling were updated for a certain generic fluorouracil product in January 2024 to minimize the risk of wrong drug errors.
FDA determined that no action was necessary for a certain authorized generic product at the time based on available information.
Enzyme replacement therapy
- Brineura (cerliponase alfa)
- Cerezyme (imiglucerase)
- Elelyso (taliglucerase alfa)
- Fabrazyme (agalsidase beta)
- Kanuma (sebelipase alfa)
- Naglazyme (galsulfase)
- Strensiq (asfotase alfa)
- Vpriv (velaglucerase alfa)
The “Boxed Warning”, “Warnings and Precautions”, and “Patient Counseling Information” sections of the labeling were updated in July 2024 to include information about hypersensitivity.
Example: Naglazyme labeling
Gadolinium-based contrast agents
- Dotarem (gadoterate meglumine)
- Elucirem (gadopiclenol)
- Eovist (gadoxetate disodium)
- Gadavist (gadobutrol)
- MultiHance (gadobenate dimeglumine)
- MultiHance Multipack (gadobenate dimeglumine)
- Omniscan (gadodiamide) Pharmacy Bulk Package
- Omniscan (gadodiamide)
- Prohance (gadoteridol injection)
- Prohance Multipack (gadoteridol injection)
The “Adverse Reactions” section of the labeling was updated in July 2024 to include information about acute pancreatitis.
Example: Prohance labeling
Galzin (zinc acetate)
Zinc Chloride Injection
The “Warnings” section of labeling was updated in April 2024 to include information on copper deficiency leading to cytopenias.
Example: Galzin labeling
FDA determined that no action was necessary at the time based on available information.
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in April 2024 to include information about acute pancreatitis.
HMG-CoA reductase inhibitors
- Altoprev (lovastatin extended-release)
- Atorvaliq (atorvastatin calcium)
- Caduet (amlodipine and atorvastatin)
- Crestor (rosuvastatin)
- Ezallor Sprinkle (rosuvastatin)
- Flolipid (simvastatin)
- Lescol XL (fluvastatin sodium)
- Liptruzet (ezetimibe and atorvastatin)
- Livalo (pitavastatin)
- Nikita (pitavastatin)
- Pravachol (pravastatin sodium)
- Roszet (rosuvastatin and ezetimibe)
- Vytorin (ezetimibe and simvastatin)
- Zypitamag (pitavastatin)
Generic products containing HMG-CoA reductase inhibitors
Isoniazid
Nydrazid (isoniazid)
Rifater (rifampin, isoniazid, and pyrazinamide)
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in February 2025 to include information about severe cutaneous adverse reactions.
Example: Isoniazid labeling
Kalydeco (ivacaftor)
Orkambi (lumacaftor and ivacaftor)
Symdeko (tezacaftor/ivacaftor)
Trikafta (elexacaftor, tezacaftor, and ivacaftor)
FDA determined that no action was necessary at the time based on available information.
Certain loratadine product (generic product for the trade name Claritin)
Certain acetaminophen and oxycodone product (generic product)
The code imprint, carton labeling, and Drug Facts Label for a certain loratadine product was updated in October 2023 to minimize the risk of wrong drug errors.
FDA determined that no action was necessary at the time based on available information for the certain acetaminophen and oxycodone generic product.
Midazolam in Sodium Chloride Injection
Certain Magnesium Sulfate in Dextrose Injection (generic product)
The container labeling for Midazolam in Sodium Chloride was updated in July 2024 to minimize the risk of wrong drug errors.
FDA determined that no action was necessary at the time based on available information for certain Magnesium Sulfate in Dextrose Injection generic product.
The “Contraindications”, “Warnings and Precautions”, and “Postmarketing Experience” sections of the labeling were updated July 2023 to include serious hypersensitivity reactions, including anaphylaxis and angioedema.
FDA determined that no action was necessary at the time based on available information.
Accidental ingestion of product desiccant
The “Warnings and Precautions”, “Adverse Reactions”, Medication Guide, and “Patient Counseling Information” sections of the labeling were updated in October 2023 to include information about desiccant removal to mitigate accidental ingestion.
The “Adverse Reactions” section of the labeling was updated in March 2024 to include information about thrombocytopenia.
FDA determined that no action was necessary at the time based on available information.
FDA determined that no action was necessary at the time based on available information.
Vyvgart (efgartigimod alfa-fcab)
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, and the “Patient Counseling Information” sections of the labeling were updated in December 2023 to include information about anaphylaxis.
Example: Vyvgart Hytrulo labeling
Vyvgart (efgartigimod alfa-fcab)
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, and the “Patient Counseling Information” sections of the labeling were updated in December 2023 to include information about infusion related reactions.
Example: Vyvgart Hytrulo labeling
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"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.
Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.
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