Addyi (flibanserin) Accidental exposure to product by child

FDA decided that no action is necessary at this time based on available information.

Betadine (povidone-iodine)

E-Z Prep (povidone-iodine)

E-Z Prep 220 (povidone-iodine)

Intentional product misuse FDA decided that no action is necessary at this time based on available information. Buphenyl (sodium phenylbutyrate) Accidental overdose

The “Overdosage” section of the labeling was updated in July 2022 to include information about overdoses.

Buphenyl labeling

Lithium-containing products

Lithobid (lithium carbonate)
Lithium Carbonate
Lithium Citrate

Sodium-glucos co-transporter (SGLT) 2 inhibitors

Farxiga (dapagliflozin)
Glyxambi (empagliflozin; linagliptin)
Invokamet (canagliflozin; metformin hydrochloride)
Invokamet XR (canagliflozin; metformin hydrochloride)
Invokana (canagliflozin)
Jardiance (empagliflozin)
Qtern (dapagliflozin; saxagliptin hydrochloride)
Qtern XR (dapagliflozin; saxagliptin hydrochloride)
Segluromet (ertugliflozin; metformin hydrochloride)
Steglatro (ertugliflozin)
Steglujan (ertugliflozin; sitagliptin phosphate)
Synjardy (empagliflozin; metformin hydrochloride)
Synjardy XR (empagliflozin; metformin hydrochloride)
Trijardy XR (empagliflozin; linagliptin; metformin hydrochloride)
Xigduo XR (dapagliflozin; metformin hydrochloride

Sodium-glucose co-transporter 2 (SGLT2) inhibitor and lithium drug interaction

The “Drug Interactions” section of the labeling for all SGLT2 inhibitors and lithium products was updated in October 2022 to include information about the risk of a drug-drug interaction.

Example: Farxiga labeling

HMG-CoA reductase inhibitors

Altoprev (lovastatin)
Caduet (amlodipine besylate; atorvastatin calcium)
Crestor (rosuvastatin calcium)
Ezallor Sprinkle (rosuvastatin)
Flolipid (simvastatin)
Lescol XL (fluvastatin sodium)
Livalo (pitavastatin)
Lipitor (atorvastatin calcium)
Liptruzet (ezetimibe; atorvastatin)
Nikita (pitavastatin)
Pravachol (pravastatin sodium)
Roszet (rosuvastatin and ezetimibe)
Vytorin (ezetimibe and simvastatin)
Zocor (simvastatin)
Zypitamag (pitavastatin)

Drug reaction with eosinophilia and systemic symptoms (DRESS)

The “Adverse Reactions” section of the labeling for Crestor, Ezallor Sprinkle and Roszet was updated between January 2023 and August 2024 to include information about DRESS.

Example: Crestor labeling

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

HMG-CoA reductase inhibitors

Altoprev (lovastatin)
Caduet (amlodipine besylate; atorvastatin calcium)
Crestor (rosuvastatin calcium)
Ezallor Sprinkle (rosuvastatin calcium)
Flolipid (simvastatin)
Lescol XL (fluvastatin sodium)
Livalo (pitavastatin)
Lipitor (atorvastatin calcium)
Liptruzet (ezetimibe; atorvastatin)
Nikita (pitavastatin)
Pravachol (pravastatin sodium)
Roszet (ezetimibe; rosuvastatin calcium)
Vytorin (ezetimibe and simvastatin)
Zocor (simvastatin)
Zypitamag (pitavastatin)

Lichen planus

The “Adverse Reactions” section of the labeling for Altoprev, Crestor, Ezallor Sprinkle, Lescol XL, Livalo, Nikita, Roszet, Vytorin, Zocor and Zypitamag was updated between May 2022 and August 2024 to include information about lichen planus.

Example: Altoprev labeling

FDA determined that no action was necessary at the time based on available information for Liptruzet, Caduet, and Lipitor.

The “Adverse Reactions” section of the labeling for Flolipid does not include information about lichen planus at this time.

HMG-CoA reductase inhibitors

Altoprev (lovastatin)
Caduet (amlodipine besylate; atorvastatin calcium)
Crestor (rosuvastatin calcium)
Ezallor Sprinkle (rosuvastatin calcium)
Flolipid (simvastatin)
Lescol XL (fluvastatin sodium)
Livalo (pitavastatin)
Lipitor (atorvastatin calcium)
Liptruzet (ezetimibe; atorvastatin)
Nikita (pitavastatin)
Pravachol (pravastatin sodium)
Roszet (ezetimibe; rosuvastatin calcium)
Vytorin (ezetimibe and simvastatin)
Zocor (simvastatin)
Zypitamag (pitavastatin)

Immune-mediated myositis

The “Warnings and Precautions” section of the labeling was updated between March 2022 and August 2024 to include information about immune-mediated necrotizing myopathy (IMNM) recurrence when the same or a different statin was administered.*

Example: Liptruzet labeling

* The labeling for Flolipid does not include the updated information about IMNM recurrence at this time.

Kalydeco (ivacaftor)

Orkambi (lumacaftor/ivacaftor)

Symdeko (tezacaftor/ivacaftor)

Trikafta (elexacaftor; tezacaftor; and ivacaftor)

Anaphylactic reaction

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

Example: Orkambi labeling

Ocrevus (ocrelizumab) Progressive multifocal leukoencephalopathy

The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling and the Medication Guide were updated in August 2022 to include information about progressive multifocal leukoencephalopathy.

Ocrevus labeling

Octagam 10%

[Immune Globulin Intravenous (Human)]

Increased hypersensitivity reactions in patients receiving certain product lots

Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions

Reblozyl (luspatercept-aamt) Extramedullary hematopoietic (EMH) masses

The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in July 2022 to include information about extramedullary hematopoietic (EMH) masses.

Reblozyl labeling

Selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake (SNRI) inhibitors

Brisdelle (paroxetine mesylate)
Celexa (citalopram hydrobromide)
Citalopram hydrobromide
Cymbalta (duloxetine hydrochloride)
Desvenlafaxine (desvenlafaxine fumarate)
Drizalma Sprinkle (duloxetine hydrochloride)
Effexor XR (venlafaxine hydrochloride)
Fetzima (levomilnacipran hydrochloride)
Fluoxetine hydrochloride
Lexapro (escitalopram oxalate)
Luvox (fluvoxamine maleate)
Paxil (paroxetine hydrochloride)
Paxil CR (paroxetine hydrochloride)
Pexeva (paroxetine mesylate)
Pristiq (desvenlafaxine succinate)
Prozac (fluoxetine hydrochloride)
Sarafem (fluoxetine hydrochloride)
Savella (milnacipran hydrochloride)
Sertraline hydrochloride
Symbyax (olanzapine; fluoxetine hydrochloride)
Trintellix (vortioxetine hydrobromide)
Venlafaxine hydrochloride
Viibryd (vilazodone hydrochloride)
Zoloft (sertraline hydrochloride)

Anosmia

The “Adverse Reactions” section of the labeling was updated between August 2023 and November 2024 to include information about anosmia.

Example: Lexapro labeling

Selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake (SNRI) inhibitors

Brisdelle (paroxetine mesylate)
Celexa (citalopram hydrobromide)
Citalopram hydrobromide
Cymbalta (duloxetine hydrochloride)
Desvenlafaxine (desvenlafaxine fumarate)
Drizalma Sprinkle (duloxetine hydrochloride)
Effexor XR (venlafaxine hydrochloride)
Fetzima (levomilnacipran hydrochloride)
Fluoxetine hydrochloride
Lexapro (escitalopram oxalate)
Luvox (fluvoxamine maleate)
Paxil (paroxetine hydrochloride)
Paxil CR (paroxetine hydrochloride)
Pexeva (paroxetine mesylate)
Pristiq (desvenlafaxine succinate)
Prozac (fluoxetine hydrochloride)
Sarafem (fluoxetine hydrochloride)
Savella (milnacipran hydrochloride)
Sertraline hydrochloride
Symbyax (olanzapine; fluoxetine hydrochloride)
Trintellix (vortioxetine hydrobromide)
Venlafaxine hydrochloride
Viibryd (vilazodone hydrochloride)
Zoloft (sertraline hydrochloride)

Hyposmia

The “Adverse Reactions” section of the labeling was updated between August 2023 and November 2024 to include information about hyposmia.

Example: Lexapro labeling

Source

Medically Reviewed By: Felicia Eddings, Pharm.D.

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

"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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