April - June 2017 | 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 |
|---|---|---|
| Adrenalin® (epinephrine injection), for intramuscular and subcutaneous use | Adrenaline (epinephrine) injection and wrong drug errors | FDA published a Dear Healthcare Provider Letter (DHCP letter) on its website to communicate the change in formulation and removal of the mydriasis indication for Adrenalin®.
The carton/container labeling for Adrenalin® was updated to remove the mydriasis indication. |
| Drug induced vitiligo-like depigmentation | FDA is evaluating the need for regulatory action. |
| Ameluz® (aminolevulinic acid hydrochloride) gel, 10%, for topical use | Transient global amnesia | The “Warnings and Precautions,” “Adverse Reactions,” and “Patient Counseling” sections of the labeling for Ameluz were updated to include transient amnestic episodes. |
| Acute acalculous cholecystitis |
Updated
The “Adverse Reactions” section of the Campath labeling and the “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the Lemtrada labeling were updated in October 2017 to include acute acalculous cholecystitis. |
| Carafate® (sucralfate) oral suspension | Medication error: administration error | The labeling for Carafate® was updated to revise the name of the drug from “Carafate suspension” to “Carafate oral suspension.”
The labeling for Carafate® was changed to include warnings of fatal complications with inappropriate intravenous administration of Carafate® oral suspension. |
| Coartem (artemether/lumefantrine) tablets | Hemolytic anemia |
Updated
The “Adverse Reactions” section of the Coartem labeling was updated in January 2018 to include hemolytic anemia. |
| Device failure | FDA issued a warning letter to Meridian Medical Technologies, Inc., summarizing significant violations of current good manufacturing practice requirements for combination products. |
Dipeptidyl peptidase-4 inhibitors
| Rhabdomyolysis |
Updated
The “Adverse Reactions” section of the dipeptidyl peptidase-4 inhibitor product labeling was updated in July 2019 to include rhabdomyolysis. Example: Januvia labeling |
| Gilenya® (fingolimod) capsules, for oral use | Rebound multiple sclerosis upon discontinuation of fingolimod |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, “Use in Specific Populations”, and “Patient Counseling Information” sections of the labeling were updated in October 2018 to include information about severe increases in disability after stopping Gilenya. An FDA Drug Safety Communication was issued on November 20, 2018. |
| Gleevec® (imatinib mesylate) tablets, for oral use | Decline in renal function | The “Warning and Precautions” section of the labeling for Gleevec® was updated to include renal toxicity. |
| Necrolytic migratory erythema |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the glucagon labeling were updated in July 2018 to include necrolytic migratory erythema. |
| Complications of allogeneic hematopoietic stem cell transplantation |
Updated
The “Warnings and Precautions”, “Medication Guide”, and “Patient Counseling” sections of the Keytruda labeling were updated in July 2017 to include complications of allogeneic hematopoietic stem cell transplantation.
The “Warnings and Precautions,” “Medication Guide,” and “Patient Counseling” sections of the Opdivo labeling were updated in November 2018 to include complications of allogeneic hematopoietic stem cell transplantation. |
| Keytruda® (pembrolizumab) injection, for intravenous use | Stevens-Johnson syndrome and toxic epidermal necrolysis | The “Warning and Precautions” section of the labeling for Keytruda was updated to include Stevens-Johnson syndrome and toxic epidermal necrolysis. |
| Pomalyst® (pomalidomide) capsules, for oral use | Ischemic colitis | FDA decided that no action is necessary at this time based on available information. |
Proton Pump Inhibitors
| Polyps of stomach and duodenum |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Medication Guide” sections of the proton pump inhibitor labeling were updated in June 2018 to include fundic gland polyps. Example: Aciphex labeling |
Proton Pump Inhibitors
| Chronic kidney disease/ acute kidney injury | FDA decided that no action is necessary at this time based on available information. |
| Repatha (evolocumab) injection, for subcutaneous use | Skin and subcutaneous tissue bacterial infections |
Updated
The “Patient Information” and “Instructions for Use” sections of the Repatha labeling were updated and the “Reference Guide” section was introduced in February 2019 to clarify the appropriate injection sites and injection methods. |
| Taxotere (docetaxel) injection concentrate, intravenous infusion | Docetaxel and neutropenic enterocolitis |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the Taxotere labeling were updated in October 2018 to include neutropenic enterocolitis. |
| Uvadex® (methoxsalen) injection, solution | Embolism and thrombosis |
Updated
The “Precautions” section of the Uvadex labeling was updated in January 2018 to include venous and arterial thromboembolism. |