Potential signals of serious risks/new safety info identified by FAERS

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

Paresthesia and taste disturbances

FDA has determined that the last approved labeling for all local anesthetics used for dental procedures is adequately labeled for dental adverse events, including paresthesia and taste disturbances, and that no further regulatory action was needed at the time.

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

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 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

 

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

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)

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

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

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)

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

Source