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  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. July – September 2015 | 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)

July – September 2015 | 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 August 26, 2019)

 

  • Articaine hydrochloride (HCl)/epinephrine bitartrate injection
  • Orabloc (articaine HCl/epinephrine bitartrate) injection
  • Septocaine (articaine HCl/epinephrine bitartrate) injection, solution

Paresthesia and taste disturbances

FDA is evaluating the need for regulatory action.

Diabeta (glyburide) tablet

Cardiovascular mortality

FDA decided that no action is necessary at this time.

Dipeptidyl peptidase IV (DPP-IV) inhibitor:

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

Renal failure

FDA is evaluating the need for regulatory action.

Dipeptidyl peptidase IV (DPP-IV) inhibitors:

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

Mouth ulcerations and stomatitis

Updated

The Adverse Reactions, Postmarketing Experience section of certain dipeptidyl peptidase IV (DPP-IV) inhibitor product labeling was updated from 2015 to 2018, to include the risk of mouth ulceration and stomatitis.

Examples include: 

Glyxambi label

Januvia label

Jentadueto label

Tradjenta label  

Honest sunscreen lotion SPF 30

Sunburn

 

Updated

FDA decided that no action is necessary at this time based on available information.

Mirvaso (brimonidine tartrate) gel

Hypersensitivity, local vascular effects, and systemic effects consistent with pharmacologic action of alpha-2 agonists

Updated

The Contraindications, Warnings and Precautions, Adverse Reactions and Patient Information sections of the brimonidine tartrate labeling was updated in July 2016 to include the risk of systemic hypersensitivity; increased flushing and erythema; pallor; and systemic effects consistent with the pharmacologic action of alpha-2 adrenergic agonists.

Mirvaso label

Nicotine replacement therapy:

  • Habitrol (nicotine) patch (transdermal system)
  • Nicoderm (nicotine) patch (transdermal system)
  • Nicotrol (nicotine) inhaler
  • Nicotrol NS (nicotine) spray
  • Nicorette & Nicorette DS (nicotine polacrilex) gum
  • Nicorette (nicotine polacrilex) lozenge

Seizures

The “Ask a doctor before use if you have” section of the labeling for Nicorette and Nicoderm was updated to include a “history of seizures.”

Nicorette Labeling

Nicoderm Labeling

FDA continues to evaluate the need for regulatory action for other nicotine replacement products.

Proton pump inhibitors:

  • Aciphex (rabeprazole sodium) tablet, sprinkle
  • Dexilant (dexlansoprazole) capsule
  • Esomeprazole magnesium capsule, oral suspension, injection
  • Esomeprazole sodium injection
  • Esomeprazole strontium capsule
  • Lansoprazole capsule
  • Naproxen/esomeprazole magnesium tablet
  • Nexium (esomeprazole magnesium) capsule, granule
  • Omeclamox-Pak (omeprazole delayed-release capsules, clarithromycin tablets, and amoxicillin capsules)
  • Omeprazole capsule, granules for oral suspension
  • Pantoprazole sodium tablet
  • Prevacid (lansoprazole) capsule
  • Prevpac (lansoprazole/amoxicillin/clarithromycin) capsule/capsule/tablet
  • Prilosec (omeprazole magnesium) capsule, tablet, granule
  • Protonix (pantoprazole sodium) tablet, injection, oral suspension
  • Rabeprazole sodium tablet
  • Vimovo (naproxen/esomeprazole magnesium) tablet
  • Zegerid (omeprazole/sodium bicarbonate) capsule, powder for oral suspension

Systemic Lupus Erythematosus (SLE)

Updated

The Warnings and Precautions and Adverse Reactions sections of the proton pump inhibitor product labeling were updated in October 2016 to include the risk of Systemic Lupus Erythematosus (SLE). 

Aciphex label 

Pseudoephedrine-containing products (numerous)

Ischemic colitis

FDA decided that no action is necessary at this time.

Recombinant human growth hormones:

  • Genotropin (somatropin) injection
  • Humatrope [somatropin (rDNA origin)] injection
  • Norditropin cartridges [somatropin (rDNA origin)] injection
  • Nutropin AQ [somatropin (rDNA origin)] injection
  • Omnitrope [somatropin (rDNA origin)] injection
  • Saizen (somatropin recombinant [rDNA origin]) injection
  • Serostim [somatropin (rDNA origin)] injection
  • Tev-Tropin [somatropin (rDNA origin)] injection

Hypersensitivity

Updated

The Contraindications, Warnings and Precautions, and Adverse Reactions sections of recombinant human growth hormone product labeling was updated in December 2016 to include the risk of hypersensitivity.  

Humatrope label

SGLT2 inhibitors:

  • Farxiga (dapagliflozin) tablet
  • Glyxambi (empagliflozin/linagliptin) tablet
  • Invokamet (canagliflozin/metformin HCl) tablet
  • Invokana (canagliflozin) tablet
  • Jardiance (empagliflozin) tablet
  • Synjardy (empagliflozin/metformin HCl) tablet
  • Xigduo XR (dapagliflozin/metformin HCl) extended release tablet

Urosepsis

“Warnings and Precautions,” “Adverse Reactions,” and “Patient Counseling” sections of the labeling and patient labeling were updated to include urosepsis.

Drugs@FDA for Labeling

Tecfidera (dimethyl fumarate) delayed-release capsule

Acute pancreatitis

FDA decided that no action is necessary at this time.

Viekira PAK (dasabuvir/ombitasvir/paritaprevir/ritonavir) tablets

Technivie (ombitasvir/paritaprevir/ ritonavir) tablets

Hepatic decompensation and hepatic failure

The “Contraindications” and “Warnings and Precautions” sections along with numerous other sections of the labeling were updated to include information about risk of hepatic decompensation and hepatic failure in patients with cirrhosis.

Viekira Labeling

Technivie Labeling

Viekira Pak & Technivie Drug Safety Communication (10/22/15)

Viekira PAK (dasabuvir/ombitasvir/paritaprevir/ritonavir) tablets

Technivie (ombitasvir/paritaprevir/ ritonavir) tablets

Renal adverse events including renal failure

Updated

FDA decided that no action is necessary at this time based on available information.

Votrient (pazopanib HCl) tablet

Interstitial lung disease (ILD)/pneumonitis

The “Warnings and Precautions” and “Patient Counseling Information” sections of the labeling were updated to include ILD and pneumonitis.

Votrient Labeling

Zonegran (zonisamide) capsule

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Updated

The Warnings and Adverse Reactions sections of zonisamide product labeling was updated in April 2016 to include the risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).  

Zonegran label