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 October 25, 2023)
|
|---|---|---|
|
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:
|
Renal failure |
Updated
FDA decided that no action is necessary at this time based on available information. |
|
Dipeptidyl peptidase IV (DPP-IV) inhibitors:
|
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: |
|
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. |
|
Nicotine replacement therapy:
|
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.” FDA continues to evaluate the need for regulatory action for other nicotine replacement products. |
|
Proton pump inhibitors:
|
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). |
|
Pseudoephedrine-containing products (numerous) |
Ischemic colitis |
FDA decided that no action is necessary at this time. |
|
Recombinant human growth hormones:
|
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. |
|
SGLT2 inhibitors:
|
Urosepsis |
“Warnings and Precautions,” “Adverse Reactions,” and “Patient Counseling” sections of the labeling and patient labeling were updated to include urosepsis. |
|
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 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. |
|
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). |