Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of August 5, 2024)

• Afinitor (everolimus)
• Afinitor Disperz (everolimus)
• Nexavar (sorafenib tosylate)

Thrombotic microangiopathy

The “Adverse Reactions” section of the labeling was updated in January 2020 and April 2020 to include thrombotic microangiopathy.

Afinitor labeling

Afinitor Disperz labeling

Nexavar labeling

• Aimovig (erenumab-aooe) injection
• Aljovy (fremanezumab-vfrm) injection
• Emgality (galcanezumab-gnlm) injection

Constipation

The “Warnings and Precautions” section of the labeling for Aimovig was updated in October 2019 to include the risk of constipation with serious complications.

Aimovig labeling

FDA decided that no action is necessary at this time based on available information for Ajovy and Emgality.  FDA is continuing to monitor the issue.

• Amoxil (amoxicillin)
• Augmentin (amoxicillin and clavulanate potassium)
• Moxatag (amoxicillin)
• Omeclamox-Pak (omeprazole, amoxicillin, and clarithromycin)
• Prevpac (amoxicillin, clarithromycin, and lansoprazole)
• Generic products containing amoxicillin; amoxicillin and clavulanate potassium; omeprazole, amoxicillin, and clarithromycin; and amoxicillin, clarithromycin, and lansoprazole

Aseptic meningitis

The “Adverse Reactions” section of the labeling was updated between March 2022 and November 2022 to include aseptic meningitis.

Example:

Amoxil labeling

FDA withdrew approval for Prevpac in the Federal Register effective May 1, 2019.

Withdrawal of Approval

• Bavencio (avelumab)
• Imfinzi (durvalumab)
• Opdivo (nivolumab)
• Tecentriq (atezolizumab)

Solid organ transplant rejection

The “Warnings and Precautions” section of the labeling was updated in November 2020 to include solid organ transplant rejection.

Bavencio labeling

Imfinzi labeling

Opdivo labeling

Tecentriq labeling

Rubidium Rb 82 generators Excess radiation exposure to the patient due to elution of the generator with an incorrect solution containing calcium The “Boxed Warning”, “Dosing and Administration,” “Contraindications,” and “Warnings and Precautions,” sections on labeling were updated to include information about using the correct solution to elute the generator and carefully following daily safety procedures for the system.  Rubidium Rb 82 generator Drug Safety Communication (4/29/19)

• Daklinza (daclatasvir dihydrochloride) tablet
• Epclusa (sofosbuvir and velpatasvir) tablet
• Harvoni (ledipasvir and sofosbuvir) tablet
• Mavyret (glecaprevir and pibrentasvir) tablet
• Sovaldi (sofosbuvir) tablets
• Technivie (ombitasvir, paritaprevir, and ritonavir)
• Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir) tablet
• Viekira XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) tablet
• Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) tablet
• Zepatier (elbasvir and grazoprevir) tablet

Dysglycemia

The “Drug Interactions” section of the labeling was updated between September 2019 and December 2019 to include information regarding altered blood glucose control resulting in hypoglycemia in patients with diabetes who received direct-acting antiviral drugs for the treatment of chronic hepatitis C virus infection.

Example: Epclusa labeling

FDA withdrew approval for Viekira XR and Technivie in the Federal Register effective February 7, 2020.

Withdrawal of Approval for Viekira XR and Technivie.

FDA withdrew approval for Viekira Pak in the Federal Register effective October 5, 2023.

Withdrawal of Approval for Viekira Pak.

Esbriet (pirfenidone) Drug induced liver injury

The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in July 2019 to include drug-induced liver injury (DILI).

Esbriet labeling

Forteo (teriparatide) Cutaneous calcification, including calciphylaxis

The “Warnings and Precautions” section of the labeling was updated in November 2020 to include cutaneous calcification including calciphylaxis.

Forteo labeling

• Fulphila (pegfilgrastim-jmdb)
• Neulasta (pegfilgrastim)

• Udenyca (pegfilgrastim-cbqv)*

Wrong dose errors in pediatric patients

FDA issued a postmarketing requirement (PMR) in October 2019 requiring Neulasta and biosimilars of Neulasta to submit pediatric assessments including developing an appropriate formulation (presentation) that can be dosed directly and accurately to pediatric patients.

*An administrative error resulted in the omission of Udenyca from this signal and was added after the initial quarterly report was posted.

• Gilenya (fingolimod) capsule
• Generic products containing fingolimod

Serious hepatotoxicity

The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information” sections of the labeling, and the “Medication Guide” were updated in August 2019 to include clinically significant liver injury, including acute liver failure requiring transplant, in patients treated with fingolimod.

Gilenya labeling

• Lamictal (lamotrigine)
• Generic products containing lamotrigine

Brugada syndrome

The “Warnings and Precautions” section of the labeling was updated in October 2020 to include the risk for cardiac rhythm and conduction abnormalities.

Example: Lamictal labeling

• Mavyret (glecaprevir and pibrentasvir) tablet
• Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) tablet
• Zepatier (elbasvir and grazoprevir) tablet

Hepatic decompensation and hepatic failure

The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, “Use in Specific Populations”, and “Patient Counseling Information” sections of the labeling for Mavyret, Zepatier and Vosevi were updated between September 2019 and December 2019 to include information regarding the risk of hepatic decompensation and hepatic failure in patients treated with HCV NS3/4A protease inhibitor containing direct acting antiviral regimens.

The “Contraindications” section of the labeling for Mavyret and Zepatier was updated between September 2019 and December 2019 to contraindicate the use in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation.

Mavyret labeling

Vosevi labeling

Zepatier labeling

An FDA Drug Safety Communication for Mavyret, Zepatier, and Vosevi was issued on August 28, 2019.

Non-steroidal anti-inflammatory drugs (NSAIDs) Drug reaction with eosinophilia and systemic symptoms (DRESS)

The “Warnings” and “Warnings and Precautions” sections of the labeling were updated in April 2021 to include drug reaction with eosinophilia and systemic symptoms (DRESS).

Example: Mobic labeling

Pomalyst (pomalidomide) Thyroid disorders

The “Adverse Reactions” section of the labeling was updated in October 2019 to include hypothyroidism and hyperthyroidism.

Pomalyst labeling

• Signifor (pasireotide)
• Signifor LAR (pasireotide)

Ketoacidosis

The “Warnings and Precautions” section of the labeling was updated in July 2020 for Signifor LAR to include ketoacidosis.

The labeling for Signifor already contained appropriate information on risk of ketoacidosis and hyperglycemia; therefore, it was not updated. 

Signifor LAR labeling

• Sustiva (efavirenz)
• Symfi Lo (efavirenz, lamivudine, tenofovir disoproxil fumarate)
• Symfi (efavirenz, lamivudine, tenofovir disoproxil fumarate)
• Atripla (efavirenz, emtricitabine, tenofovir disoproxil fumarate)
• Generic products containing efavirenz

Ataxia and encephalopathy

The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling for efavirenz-containing products were updated in October 2019 to include late-onset neurotoxicity, including ataxia and encephalopathy.

Example: Symfi labeling

The FDA withdrew approval for Sustiva tablets and capsules in the Federal Register effective May 23, 2024, and July 3, 2024, respectively.

Withdrawal of Approval for Sustiva tablets

Withdrawal of Approval for Sustiva capsules

• Tygacil (tigecycline)
• Generic products containing tigecycline

Hypofibrinogenemia

The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in 2020 to include hypofibrinogenemia.

Example: Tygacil labeling

• Vidaza (azacitidine)
• Generic products containing azacitidine

Differentiation syndrome

The “Adverse Reactions” section of the labeling was updated between February 2020 and July 2020 to include differentiation syndrome.

Example: Vidaza labeling

FDA withdrew approval for Dacogen in the Federal Register effective October 5, 2023.

Withdrawal of Approval for Dacogen.

*An administrative error resulted in the omission of Dacogen from the initial quarterly report.

Zydelig (idelalisib) Heart failure FDA decided that no action is necessary at this time based on available information.

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