Drugs

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) April - June 2016

Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of October 4, 2016)

Antidepressants

Stress cardiomyopathy

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

Diphenhydramine

QT Prolongation

FDA is evaluating the need for regulatory action.

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)

FDA is evaluating the need for regulatory action.

Entresto (sacubitril/valsartan) tablets

Risk of rhabdomyolysis with concomitant use of statin therapy

FDA is evaluating the need for regulatory action.

First and second generation histamine H1 antagonists

Seizures

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

Harvoni (ledipasvir and sofosbuvir) tablets

Drug-Drug Interaction: ledipsavir/sofosbuvir and lopinavir/ritonavir

FDA is evaluating the need for regulatory action.

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.

FDA is evaluating the need for regulatory action

Krystexxa (pegloticase) injection for intravenous use

Hemolytic anemia and methemoglobinemia

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

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)

FDA is evaluating the need for regulatory action.

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

Thrombotic microangiopathy

FDA is evaluating the need for regulatory action.

Tracleer (bosentan) tablets

Anaphylaxis

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

FDA is evaluating the need for regulatory action.

  • 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

FDA is evaluating the need for regulatory action.

Unituxin (dinutuximab) injection for intravenous use

Transverse myelitis

FDA is evaluating the need for regulatory action.

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

Acute generalized exanthematous pustulosis (AGEP)

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

 

Page Last Updated: 10/05/2016
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