Cancer Drugs Dominate New FDA Watch List
"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
Adrenalin (epinephrine) injection and wrong drug errors
FDA published a Dear Healthcare Provider 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.
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.
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.
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
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.
GlucaGen (glucagon [recombinant DNA 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.
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.
Source: FDA"
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