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  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. April - June 2016 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

April - June 2016 | Potential Signals of Serious Risks/New Safety Information Identified by 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 April 16, 2020)

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:

  • Avonex (interferon beta-1a) injection
  • Betaseron (interferon beta-1b) subcutaneous injection
  • Extavia (interferon beta-1b) subcutaneous injection
  • Plegridy and Plegridy PEN (peginterferon beta-1a) subcutaneous injection
  • Rebif and Rebif Rebidose (interferon beta-1a) subcutaneous injection

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.

Betaseron labeling

Extavia labeling

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.

Drugs@FDA

Dipeptidyl peptidase 4 (DPP-4) inhibitor tablets:

  • Glyxambi (empagliflozin/ linagliptin) tablets
  • Kazano (alogliptin /metformin hydrochloride) tablets
  • Janumet (sitagliptin /metformin hydrochloride) tablets
  • Janumet XR (sitagliptin /metformin hydrochloride) extended-release tablets
  • Januvia (sitagliptin) tablets
  • Jentadueto XR (linagliptin /metformin hydrochloride) extended-release tablets
  • Jentadueto (linagliptin/metformin hydrochloride ) tablets
  • Kombiglyze XR (saxagliptin /metformin hydrochloride) extended-release tablets
  • Nesina (alogliptin) tablets
  • Onglyza (saxagliptin) tablets
  • Oseni (alogliptin /pioglitazone) tablets
  • Tradjenta (linagliptin) 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.

Direct-acting antivirals:

  • Daklinza (daclatasvir) tablets
  • Harvoni (ledipasvir and sofosbuvir) tablets
  • Olysio (simeprevir) capsules
  • Sovaldi (sofosbuvir) tablets
  • Technivie (ombitasvir, paritaprevir, and ritonavir) tablets
  • Viekira Pak (ombitasvir, paritaprevir, and ritonavir; dasabuvir) tablets
  • Zepatier (elbasvir and grazoprevir) tablets

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.

Drugs@FDA

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.

Granix labeling

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.

  • Hydralazine hydrochloride tablets
  • Hydroxyzine hydrochloride tablets
  • Hydroxyzine pamoate capsules

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.

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.

Krystexxa labeling

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.

Ophthalmic Products Drug Safety Communication (3/15/16)

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.

Opsumit supplement approval letter

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.

Rapivab labeling

SGLT2 inhibitors:

  • Farxiga (dapagliflozin) tablets
  • Glyxambi (empagliflozin /linagliptin) tablets
  • Invokamet (canagliflozin /metformin hydrochloride) tablets
  • Invokana (canagliflozin) tablets
  • Jardiance (empagliflozin) tablets
  • Synjardy (empagliflozin /metformin hydrochloride) tablets
  • Xigduo XR (dapagliflozin/metformin hydrochloride) extended-release tablets

Acute pancreatitis

FDA is evaluating the need for regulatory action.

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.

Tecfidera labeling

  • Lamisil (terbinafine hydrochloride) tablets
  • Terbinafine hydrochloride-containing oral drugs

Thrombotic microangiopathy

Updated

The “Warnings and Precautions” and “Adverse Reactions” sections of the Lamisil labeling were updated January 2017 to include thrombotic microangiopathy.

Lamisil labeling

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).

Tracleer labeling

  • Treanda (bendamustine hydrochloride) infusion
  • Bendeka (bendamustine hydrochloride) injection

Drug Reaction with Eosinophilia and Systematic Symptoms (DRESS)

FDA is evaluating the need for regulatory action.

  • Treanda (bendamustine hydrochloride) injection
  • Bendeka (bendamustine hydrochloride) injection

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.

Treanda labeling

Bendeka labeling

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.

Unituxin labeling

  • Vistaril (hydroxyzine pamoate capsules, suspension
  • Xyzal (levocetirizine dihydrochloride) tablets, solution
  • Zyrtec (cetirizine hydrochloride) tablets, capsules, Children’s syrup

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).

Vistaril labeling

Xyzal labeling

Zecuity (sumatriptaniontophoretic) transdermal system

Burns and Scars

Teva has temporarily suspended sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch.

FDA is continuing to evaluate this issue and the need for regulatory action.

Zecuity Drug Safety Communication (06/10/16)

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.

Zydelig labeling