July - September 2018 | 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 |
|---|---|---|
| Atypical antipsychotics and serotonin syndrome |
Updated
FDA determined that no action is necessary at this time based on available information.
|
Amphetamines and amphetamine congeners for management of obesity
| Death and sudden death |
Updated
FDA determined that no action is necessary at this time based on available information. FDA is continuing to monitor the issue. |
| Central sleep apnea associated with the use of ticagrelor |
Updated
The “Adverse Reactions” section of the labeling was updated in September 2020 to include central sleep apnea, Cheyne-Stokes respiration. Example: Brilinta labeling |
| Rhabdomyolysis due to Drug-Drug Interaction between ticagrelor and certain HMG-CoA reductase inhibitors (atorvastatin and rosuvastatin) |
Updated
FDA decided that no action is necessary at this time based on available information. |
| Hemophagocytic Lymphohistiocytosis (HLH) | FDA decided that no action is necessary at this time based on available information. |
| Stroke, intracranial hemorrhage, and/or cervicocephalic arterial dissection | The “Boxed Warning” section of labeling was updated to include the risk of stroke. The “Warnings and Precautions” section of labeling was updated to include the risk of stroke and cervicocephalic arterial dissection. Campath labeling Lemtrada labeling |
| Daptomycin injection | Infusion - related reactions | Eight drug product lots released to the market and within expiry were recalled voluntarily, with FDA’s agreement, up to the Hospital/Retail level, effective 6/29/2018, as published on FDA’s website. Daptomycin injection drug safety recall |
| Acute kidney injury |
Updated
FDA determined that no action is necessary at this time based on available information. FDA is continuing to monitor the issue. |
| Hypersensitivity |
Updated
The “Adverse Reactions” section of the Genvoya, Odefsey, and Descovy labeling was updated between December 2018 and December 2019 to include angioedema, urticaria, and rash. The “Adverse Reactions” section of the Vemlidy and Biktarvy labeling was updated between February 2019 and June 2019 to include angioedema and urticaria. |
| Injectable insulins and insulin analogs | Cutaneous amyloidosis |
Updated
The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Information” sections of the injectable insulin and insulin analog labeling were updated between October 2019 and November 2019 to include cutaneous amyloidosis. Example: Humulin N labeling |
Intravenous iron replacement products
| Fatal and severe hypersensitivity reactions |
Updated
FDA determined that no action is necessary at this time based on available information. |
| Pegfilgrastim injection products | Alveolar hemorrhage, hemoptysis |
Updated
The “Adverse Reactions” section of the pegfilgrastim product labeling was updated between April 2019 and May 2019 to include alveolar hemorrhage. Example: Neulasta labeling |
| Ocrevus (ocrelizumab) injection | Anaphylaxis |
Updated
The “Warnings and Precautions” section of the Ocrevus labeling was updated in January 2020 to include anaphylaxis. |
PCSK9 Inhibitors
| Influenza-like illness | The “Postmarketing Experience” section of labeling was updated to include flu-like illness. Praluent labeling |
| Phenol | Serious adverse events associated with phenol-containing teething products |
Updated
FDA plans to issue an FDA-initiated proposed order that addresses the GRASE status of OTC oral health care drug products containing phenol preparations labeled for anesthetic/analgesic indications. |
Proton Pump Inhibitors
| Rebound acid hypersecretion | FDA decided that no action is necessary at this time based on available information. |
| Rituxan Hycela (rituximab and hyaluronidase human) injection, and rituximab for injection products | Incorrect route of administration |
Updated
The “Dosage and Administration” section of the labeling was revised in May 2020 to include information about incorrect route of administration. |
| Xifaxan (rifaximin) tablets | Rhabdomyolysis |
Updated
The “Adverse Reactions” section of the labeling was updated in November 2020 to include information about rhabdomyolysis. |