Drugs

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): April - June 2017

Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of September 30, 2017)

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®.

Adrenalin® DHCP letter
 

 

The carton/container labeling for Adrenalin® was updated to remove the mydriasis indication.

Adrenalin® package insert labeling

  • Aldara® (imiquimod) cream, 5%, for topical  use only
  • Zyclara (imiquimod) cream, 3.75%, for topical use
  • Zyclara (imiquimod) cream, 2.5%, for topical use

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.

Ameluz® labeling

  • Campath (alemtuzumab) injection, for intravenous use
  • Lemtrada (alemtuzumab) injection, for intravenous use

Acute acalculous cholecystitis

FDA is evaluating the need for regulatory action.

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.

Carafate® labeling

Coartem (artemether/lumefantrine) tablets

Hemolytic anemia

FDA is evaluating the need for regulatory action.

  • Epipen® (epinephrine injection, USP), Auto-injector 0.3 mg, for intramuscular or subcutaneous use
  • Epipen® Jr (epinephrine injection, USP) Auto-injector 0.15 mg, for intramuscular or subcutaneous use

Device failure

FDA issued a warning letter to Meridian Medical Technologies, Inc., summarizing significant violations of current good manufacturing practice requirements for combination products.

Epipen® Warning Letter

Dipeptidyl peptidase-4 inhibitors

  • Glyxambi (empagliflozin and linagliptin) tablets, for oral use
  • Janumet (sitagliptin and metformin hydrochloride) tablets, for oral use
  • Janumet XR (sitagliptin and metformin hydrochloride extended-release) tablets, for oral use
  • Januvia (sitagliptin) tablets, for oral use
  • Jentadueto (linagliptin and metformin hydrochloride) tablets, for oral use
  • Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets, for oral use
  • Kazano (alogliptin and metformin hydrochloride) tablets, for oral use
  • Kombiglyze XR (saxagliptin and metformin hydrochloride extended-release) tablets, for oral use
  • Nesina (alogliptin) tablets, for oral use
  • Onglyza (saxagliptin) tablets, for oral use
  • Oseni (alogliptin and pioglitazone) tablets, for oral use
  • Qtern (dapagliflozin and saxagliptin) tablets, for oral use
  • Tradjenta (linagliptin) tablets, for oral use

Rhabdomyolysis

FDA is evaluating the need for regulatory action.

Gilenya® (fingolimod) capsules, for oral use

Rebound multiple sclerosis upon discontinuation of fingolimod

FDA is evaluating the need for regulatory action.

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.

Gleevec® labeling

  • GlucaGen (glucagon [rDNA origin] for injection), for subcutaneous, intramuscular, or intravenous use
  • Glucagon for injection, for subcutaneous, intramuscular, or intravenous use

Necrolytic migratory erythema

FDA is evaluating the need for regulatory action.

  • Keytruda® (pembrolizumab) injection, for intravenous use
  • Opdivo® (nivolumab) injection, for intravenous use

Complications of allogeneic hematopoietic stem cell transplantation

FDA is evaluating the need for regulatory action.

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.

Keytruda® labeling

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

  • Aciphex (rabeprazole sodium) delayed-release tablets, for oral use
  • Esomeprazole strontium delayed-release capsules, for oral use
  • Nexium (esomeprazole magnesium) delayed-release capsules, for oral use
  • Nexium (esomeprazole magnesium) for delayed-release oral suspension
  • Nexium I.V. (esomeprazole sodium) for injection, for intravenous use
  • Prevacid (lansoprazole), delayed-release capsules, for oral use
  • Prevacid Solutab (lansoprazole) delayed-release orally disintegrating tablets
  • Prilosec (omeprazole) delayed-release capsules
  • Prilosec (omeprazole) delayed-release oral suspension
  • Protonix (pantoprazole sodium) delayed-release tablets, for oral use
  • Protonix (pantoprazole sodium) for delayed-release oral suspension
  • Protonix IV (pantoprazole sodium) for injection, for intravenous use

Polyps of stomach and duodenum

FDA is evaluating the need for regulatory action.

Proton Pump Inhibitors

  • Aciphex (rabeprazole sodium) delayed-release tablets, for oral use
  • Esomeprazole strontium delayed-release capsules, for oral use
  • Nexium (esomeprazole magnesium) delayed-release capsules, for oral use
  • Nexium (esomeprazole magnesium) for delayed-release oral suspension
  • Nexium I.V. (esomeprazole sodium) for injection, for intravenous use
  • Prevacid (lansoprazole), delayed-release capsules, for oral use
  • Prevacid Solutab (lansoprazole) delayed-release orally disintegrating tablets
  • Prilosec (omeprazole) delayed-release capsules
  • Prilosec (omeprazole) delayed-release oral suspension
  • Protonix (pantoprazole sodium) delayed-release tablets, for oral use
  • Protonix (pantoprazole sodium) for delayed-release oral suspension
  • Protonix IV (pantoprazole sodium) for injection, for intravenous use

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

FDA is evaluating the need for regulatory action

Taxotere (docetaxel) injection concentrate, intravenous  infusion

Docetaxel and neutropenic enterocolitis

FDA is evaluating the need for regulatory action.

Uvadex® (methoxsalen) injection, solution

Embolism and thrombosis

FDA is evaluating the need for regulatory action.

Page Last Updated: 10/06/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English