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  6. Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between July – September 2015
  1. Surveillance: Post Drug-Approval Activities

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between July – September 2015

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between July – September 2015

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of January 13, 2016)

 

  • 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

The “Postmarketing Experience” section of the labeling for products containing linagliptin was updated to include mouth ulcerations and stomatitis.

Glyxambi Labeling

Tradjenta Labeling

Jentadueto Labeling

FDA is evaluating the need for regulatory action for products containing sitagliptin, alogliptin, and saxagliptin.

Honest sunscreen lotion SPF 30

Sunburn

FDA is evaluating the need for regulatory action.

Mirvaso (brimonidine tartrate) gel

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

FDA is evaluating the need for regulatory action.

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)

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

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)

FDA is evaluating the need for regulatory action.