April - June 2016 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
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Product Name: Trade (Active Ingredient) or Product Class |
Potential Signal of a Serious Risk / New Safety Information |
Additional Information |
|---|---|---|
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Antidepressants |
Takotsubo cardiomyopathy |
Updated
The “Adverse Reactions” section of the labeling for serotonin and norepinephrine reuptake inhibitor (SNRI) antidepressants was updated December 2017 to include Takotsubo cardiomyopathy. Example: Pristiq labeling |
|
Beta Interferons:
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Drug-induced lupus |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling for Betaseron and Extavia were updated April and May 2016 to include drug-induced lupus. FDA decided that no action is necessary at this time for Avonex, Plegridy or Rebif based on available information. |
|
Corlanor (ivabradine) tablet |
Concomitant use of ivabradine with drugs that slow the heart rate (e.g. beta blockers, clonidine, digoxin, diltiazem, ivabradine, and verapamil) may increase risk of bradycardia. |
FDA decided that no action is necessary for ivabradine at this time based on available information The “Drug Interactions” section of the labeling for other negative chronotropes was updated to include information about bradycardia when ivabradine is used concomitantly. |
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Dipeptidyl peptidase 4 (DPP-4) inhibitor tablets:
|
Pemphigoid |
Updated
The “Warnings and Precautions,” “Adverse Reactions,” and “Medication Guide” sections of the labeling for the dipeptidyl peptidase 4 (DPP-4) inhibitors were updated December 2016 through January 2017 to include bullous pemphigoid. Example: Glyxambi labeling |
|
Diphenhydramine |
QT Prolongation |
Updated
FDA decided that no action is necessary at this time based on available information. |
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Direct-acting antivirals:
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Hepatitis B reactivation Direct-acting antivirals Drug Safety Communication (October 4, 2016) |
Updated
The “Boxed Warning,” “Warning and Precautions,” “Dosage and Administration,” and “Patient Information” sections of the labeling for direct-acting antivirals were updated February 2017 to include Hepatitis B reactivation. Example: Daklinza labeling |
|
Entresto (sacubitril/valsartan) tablets |
Risk of rhabdomyolysis with concomitant use of statin therapy |
Updated
FDA decided that no action is necessary at this time based on available information. |
|
First and second generation histamine H1 antagonists |
Seizures |
Updated
FDA decided that no action is necessary at this time based on available information.
|
|
Fluroquinolone antibiotics |
Drug-induced side effects |
The “Boxed Warning,” and “Warnings and Precautions,” sections of the labeling were updated with information about disabling and potentially irreversible serious adverse reactions that have occurred together. Fluroquinolone antibiotics Drug Safety Communication (May 12, 2016) |
|
Granix (tbo-filgrastime) injection for subcutaneous use |
Glomerulonephritis |
Updated
The “Warnings and Precautions,” “Adverse Reactions,” and “Patient Counseling Information” sections of the labeling for Granix were updated February 2017 to include glomerulonephritis. |
|
Harvoni (ledipasvir and sofosbuvir) tablets |
Drug-Drug Interaction: ledipsavir/sofosbuvir and lopinavir/ritonavir |
Updated
FDA decided that no action is necessary at this time based on available information. |
|
HMG-CoA reductase inhibitors |
Interstitial lung disease |
FDA is evaluating the need for regulatory action. |
|
Increase in medication error reports associated with confusion between hydroxyzine and hydralazine. |
Updated
The container label text and highlight colors for hydroxyzine were revised to better differentiate the product from hydralazine. |
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Krystexxa (pegloticase) injection for intravenous use |
Hemolytic anemia and methemoglobinemia |
Updated
The “Boxed Warning,” and “Warnings and Precautions,” sections of the labeling for Krystexxa were updated September 2016 to include hemolytic anemia and methemoglobinemia. |
|
Ophthalmic products: container closure system |
Manufacturing problem: loose or unsecured tamper evident rings can fall off the bottle neck onto patients’ eyes when bottle is tilted or inverted to apply eye drops |
FDA required changes to the container closure design to either secure the tamper-evident ring or change the container closure design. |
|
Opsumit (macitentan) tablets |
Hepatic and hepatobiliary disorders |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the Opsumit labeling were updated October 2016 to include hepatic and hepatobiliary disorders. |
|
Rapivab (peramivir) injection for intravenous use |
Anaphylaxis/Angioedema |
The “Contraindications,” “Warnings and Precautions,” “Adverse Reactions,” “Postmarketing Experience,” and “Patient Counseling Information” sections of the labeling were updated to include information on hypersensitivity and anaphylaxis. |
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SGLT2 inhibitors:
|
Acute pancreatitis |
Updated
FDA decided that no action is necessary at this time based on available information. |
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Tecfidera (dimethyl fumarate) delayed-release capsules |
Idiosyncratic drug-induced liver injury (DILI) |
Warning
The “Warnings and Precautions,” “Adverse Reactions,” and “Patient Counseling” sections of the Tecfidera labeling were updated January 2017 to include the risk for liver injury. |
|
Thrombotic microangiopathy |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the Lamisil labeling were updated January 2017 to include thrombotic microangiopathy. |
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Tracleer (bosentan) tablets |
Anaphylaxis Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) |
Updated
The “Warnings and Precautions,” “Contraindications,” and “Adverse Reactions” sections of the Tracleer labeling were updated October 2016 to include anaphylaxis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). |
|
Drug Reaction with Eosinophilia and Systematic Symptoms (DRESS) |
Updated
The “Warning and Precautions” and “Adverse Reactions” sections of the labeling were updated in October 2016 for Treanda and in February 2017 for Bendeka to include drug reaction with eosinophilia and systemic symptoms (DRESS). |
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Hepatic and hepatobiliary disorders |
Updated
The “Warnings and Precautions,” “Adverse Reactions,” and “Patient Counseling” sections of the bendamustine labeling were updated October 2016 to February 2017 to include hepatotoxicity. |
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Unituxin (dinutuximab) injection for intravenous use |
Transverse myelitis |
Updated
The “Dosage and Administration,” “Warnings and Precautions,” “Adverse Reactions,” and “Patient Counseling Information” sections of the Unituxin labeling were updated March 2017 to include transverse myelitis. |
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Acute generalized exanthematous pustulosis (AGEP) |
Updated
The “Precautions” and “Adverse Reactions” sections of the Vistaril labeling and the “Adverse Reactions” section of the Xyzal labeling were updated November 2016 to include acute generalized exanthematous pustulosis (AGEP). |
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Zecuity (sumatriptaniontophoretic) transdermal system |
Burns and Scars |
Updated
The FDA withdrew approval for Zecuity in the Federal Register effective July 2, 2020. |
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Zydelig (idelalisib) tablets |
Fatal infections |
Updated
The “Boxed Warning,” “Warnings and Precautions,” “Adverse Reactions,” and “Patient Counseling Information” sections of the Zydelig labeling were updated September 2016 to include fatal infections. |