January - March 2019 | Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)
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)
The “Adverse Reactions” section of the labeling was updated in January 2020 and April 2020 to include thrombotic microangiopathy.
- Aimovig (erenumab-aooe) injection
- Aljovy (fremanezumab-vfrm) injection
- Emgality (galcanezumab-gnlm) injection
The “Warnings and Precautions” section of the labeling for Aimovig was updated in October 2019 to include the risk of constipation with serious complications.
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
The “Adverse Reactions” section of the labeling was updated between March 2022 and November 2022 to include aseptic meningitis.
Example:
FDA withdrew approval for Prevpac in the Federal Register effective May 1, 2019.
- Bavencio (avelumab)
- Imfinzi (durvalumab)
- Opdivo (nivolumab)
- Tecentriq (atezolizumab)
The “Warnings and Precautions” section of the labeling was updated in November 2020 to include solid organ transplant rejection.
- 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
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.
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in July 2019 to include drug-induced liver injury (DILI).
The “Warnings and Precautions” section of the labeling was updated in November 2020 to include cutaneous calcification including calciphylaxis.
- Fulphila (pegfilgrastim-jmdb)
- Neulasta (pegfilgrastim)
- Udenyca (pegfilgrastim-cbqv)*
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
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.
- Lamictal (lamotrigine)
- Generic products containing lamotrigine
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
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.
An FDA Drug Safety Communication for Mavyret, Zepatier, and Vosevi was issued on August 28, 2019.
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
The “Adverse Reactions” section of the labeling was updated in October 2019 to include hypothyroidism and hyperthyroidism.
- Signifor (pasireotide)
- Signifor LAR (pasireotide)
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.
- 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
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.
- Tygacil (tigecycline)
- Generic products containing tigecycline
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
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.
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