Pediatric Advisory Recommendations and Updates
The Pediatric Advisory Committee (PAC) advises and makes recommendations to the FDA about matters involving pediatrics. One of the PAC’s responsibilities is to review, evaluate, and make recommendations on adverse event reports of post market pediatric safety data for certain medical products. The safety reviews enable the FDA to identify safety concerns in children that may not be possible to detect before the product is marketed. The PAC also advises on aspects of Humanitarian Device Exemptions (HDEs) for certain HDE devices that are approved in pediatric patients.
The spreadsheet below includes medical products that have been shared with the PAC as required by federal law, FDA’s safety review information and the PAC’s recommendations.
Product Name | Safety Review | Date Posted | |
---|---|---|---|
Epicel (cultured epidermal autografts) | Epicel (cultured epidermal autografts) Memorandum | 5/9/2024 | |
Liposorber LA-15 System | Liposorber LA-15 System Executive Summary | 5/9/2024 | |
The Tether - Vertebral Body Tethering System | The Tether - Vertebral Body Tethering System Executive Summary | 5/9/2024 | |
Medtronic Activa Neurosimulator for Dystonia Treatment | Medtronic Activa Neurosimulator for Dystonia Treatment Executive Summary | 5/9/2024 | |
Minimally Invasive Deformity Correction (MID-C) System | Minimally Invasive Deformity Correction (MID-C) System Executive Summary | 5/9/2024 | |
Isentress (raltegravir potassium) | Isentress Safety and Utilization Review | 09/12/2016 | |
Lysteda (tranexamic acid) | Lysteda Safety and Utilization Review | 09/12/2016 | |
Salonpas Relief (methyl salicylate 10% and 1-menthol 3%P Patch) | Salonpas Relief Safety and Utilization Review | 09/12/2016 | |
Aleve PM® (naproxen sodium 220 mg and diphenhydramine hydrochloride 25 mg) | Aleve PM® Safety and Utilization Review | 02/03/2017 | |
Astepro (azelastine hydrochloride) | Astepro Safety and Utilization Review | 02/03/2017 | |
Jetrea® (ocriplasmin) Intravitreal Injection | Jetrea® Safety and Utilization Review | 02/03/2017 | |
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets, for oral | Quartette Safety and Utilization Review | 02/03/2017 | |
Spectazole (econazole nitrate) cream, 1% Ecoza (econazole nitrate) topical foam, | Spectazole/Ecoza Safety and Utilization Review | 02/03/2017 | |
Truvada® (emtricitabine and tenofovir disoproxil fumarate) | Truvada® Safety and Utilization Review | 02/03/2017 | |
Xerese® (5% acyclovir and 1% hydrocortisone cream) | Xerese® Safety and Utilization Review | 02/03/2017 | |
Aloxi (palonosetron hydrochloride) | Aloxi Safety and Utilization Review | 08/04/2017 | |
Arnuity Ellipta (fluticasone furoate) |
|
08/04/2017 | |
Asmanex HFA and Asmanex Twisthaler (mometasone furoate inhalation) | Asmanex HFA and Asmanex Twisthaler Safety and Utilization Review | 08/04/2017 | |
Cymbalta (duloxetine) | Cymbalta Safety and Utilization Review | 08/04/2017 | |
Emsam (selegiline transdermal system) | Emsam Safety and Utilization Review | 08/04/2017 | |
GRASTEK® (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use | GRASTEK Safety and Utilization ReviewFDA Drug Utilization Information on GRASTE | 08/04/2017 | |
Latisse® (bimatoprost ophthalmic solution) 0.03% | Latisse® Safety and Utilization Review | 08/04/2017 | |
Namenda and Namenda XR extended-release (memantine hydrochloride) | Namenda and Namenda XR Safety and Utilization Review | 08/04/2017 | |
ORALAIR (Sweet Vernal, Orchard Perennial rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for sublingual Use | ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for Sublingual Use Memorandum |
08/04/2017 | |
Priftin® (rifapentine) | Priftin® Safety and Utilization Review | 08/04/2017 | |
Reyataz® (atazanavir) | Reyataz® Safety and Utilization Review | 08/04/2017 | |
Taclonex (betamethasone dipropionate/calcipotriene hydrate) 0.064%/0.005% | Taclonex Safety and Utilization Review | 08/04/2017 | |
Zetonna (ciclesonide) | Zetonna (ciclesonide) Safety and Utilization Review | 08/04/2017 | |
Dymista (azelastine hydrochloride fluticasone propionate) | Dymista (azelastine hydrochloride fluticasone propionate) Pediatric Safety Review | 01/07/2018 | |
Edurant (rilpivirine) Complera and Odefsey | Edurant (rilpivirine) Complera and Odefsey Pediatric Safety Review | 01/07/2018 | |
Merrem IV (meropenem) | Merrem IV (meropenem) Pediatric Safety Review | 01/07/2018 | |
Naftin (nafifine hydrochloride) | Naftin (nafifine hydrochloride) Pediatric Safety and Drug Utilization Review | 01/07/2018 | |
OTIPRO (ciprofloxacin otic suspension) | OTIPRO (ciprofloxacin otic suspension) Pediatric Safety Review | 01/07/2018 | |
PAZEO (olopatadine hydrochloride ophthalmic solution) | PAZEO (olopatadine hydrochloride ophthalmic solution) Pediatric Safety Review | 01/07/2018 | |
QNASL beclomethasone dipropionate) nasal aerosol | QNASL beclomethasone dipropionate) nasal aerosol Safety Review | 01/07/2018 | |
Treximet (naproxen sodium sumatriptan succinate) | Treximet (naproxen sodium sumatriptan succinate) Safety Review | 01/07/2018 | |
Valcyte (valganciclovir) | Valcyte (valganciclovir) Safety Review | 01/07/2018 | |
Atropine Sulfate Ophthalmic Solution, USP 1% | Atropine Sulfate Ophthalmic Solution, USP 1% Pediatric Postmarketing Pharmacovi | 03/05/2018 | |
Emend (aprepitant) Capsule and Oral Suspension | Emend (aprepitant) Capsule and Oral Suspension Pediatric Safety Review | 03/05/2018 | |
Epicel (cultured epidermal autografts) | Epicel (cultured epidermal autografts) Executive Summary, Pediatric Safety Update | 03/05/2018 | |
Epiduo Forte (adapalene/benzoyl peroxide, 0.3%/2.5%) gel | Epiduo Forte (adapalene/benzoyl peroxide, 0.3%/2.5%) gel Pediatric Safety Review | 03/05/2018 | |
Flourish Pediatric Esophageal Atresia Device | Flourish 2018 Executive Summary | 03/05/2018 | |
Gadavist (gadobutrol), Eovist or Primovist (gadoxetate disodium) | Gadavist (gadobutrol) Eovist or Primovist (gadoxetate disodium) Pediatric Safety Review | 03/05/2018 | |
Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) | Gardasil 9 Pediatric Safety and Utilization Review | 03/05/2018 | |
Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) oral | Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) oral tablets Pediatric Safety Review | 03/05/2018 | |
Kapvay (clonidine extended-release) tablets | Kapvay® (clonidine extended-release) tablets Pediatric Safety and Drug Utilization | 03/05/2018 | |
Nucala (mepolizumab) | Nucala (mepolizumab) Pediatric Safety Review | 03/05/2018 | |
Saphris (asenapine) | Saphris (asenapine) Pediatric Safety Review | 03/05/2018 | |
Tivicay (dolutegravir) | Tivicay (dolutegravir) Pediatric Safety Review | 03/05/2018 | |
Trumenba Meningococcal Group B Vaccine | Trumenba Pediatric Pediatric Safety Review | 03/05/2018 | |
Banzel (rufinamide) | Banzel (rufinamide) Pediatric Safety Review Banzel (rufinamide) Pediatric Utilization Review | 04/25/2018 | |
Liposorber LA-15 System | Liposorber LA-15 System 2018 Executive Summary | 04/25/2018 | |
Medtronic Activa Dystonia Therapy | Medtronic Activa Dystonia Therapy 2018 Executive Summary | 04/25/2018 | |
Adzenys XR and Dyanavel XR (amphetamine) | Dyanavel Pediatric Safety Review | 06/13/2018 | |
Anthim (obiltoxaximab) | Anthim Pediatric Safety Review | 06/13/2018 | |
Aptensio XR and Quillichew (methylphenidate hydrochloride) | Aptensio XR and Quillichew ER Pediatric Safety Review | 06/13/2018 | |
Cinqair (reslizumab) | Cinqair Pediatric Safety Review | 06/13/2018 | |
Cutivate (fluticasone propionate) | Cutivate Pediatric Safety Review | 06/13/2018 | |
Descovy (emtricitabine and tenofovir alafenamide) | Descovy Pediatric Safety Review | 06/13/2018 | |
Epivir (lamivudine) | Epivir Pediatric Safety Review | 06/13/2018 | |
Kaletra (lopinavir and ritonavir) | Kaletra Pediatric Safety Review | 06/13/2018 | |
Natroba (spinosad) | Natroba Pediatric Safety Review | 06/13/2018 | |
Noxafil (posaconazole) | Noxafil Pediatric Safety Review | 06/13/2018 | |
Oraltag (iohexol) | Oraltag Pediatric Safety Review | 06/13/2018 | |
Otovel Otic Solution (ciprofloxacin and fluocinolone acetonide) | Ovotel Pediatric Safety Review | 06/13/2018 | |
Prilosec (omeprazole) | Prilosec Pediatric Safety Review | 06/13/2018 | |
ProAir RespiClick (abuterol sulfate) | ProAir Respiclick Pediatric Safety Review | 06/13/2018 | |
Procysbi (cysteamine bitartrate) | Procysbi Pediatric Safety Review | 06/13/2018 | |
Teflaro Injection (ceftaroline fosamil) | Teflaro Pediatric Safety Review | 06/13/2018 | |
Tetracaine Hydrochloride Ophthalmic Solution (tetracaine hydrochloride) | Tetracaine Pediatric Safety Review | 06/13/2018 | |
Xopenex HFA Inhalation Aerosol (levalbuterol) | Xopenex Pediatric Safety Review | 06/13/2018 | |
Bexsero (Meningococcal Group B Vaccine) | Bexsero Safety Review | 09/12/2018 | |
Contegra Pulmonary Valved Conduit (Humanitarian Device Exemption [HDE]) | Contegra 2018 Executive Summary | 09/12/2018 | |
Elana Surgical Kit (HDE) | Elana Surgical Kit 2018 Executive Summary | 09/12/2018 | |
Enterra Therapy System (HDE) | Enterra 2018 Executive Summary | 09/12/2018 | |
Entocort EC (budesonide) | Entocort EC Safety Review | 09/12/2018 | |
Epzicom (abacavir sulfate and lamivudine) and Ziagen (abacavir sulfate) | Epzicom and Ziagen Safety Review | 09/12/2018 | |
Kovanaze (tetracaine HCl and oxymetazoline HCl) | Kovanaze Safety Review | 09/12/2018 | |
Lamictal (lamotrigine) | Lamictal Safety Review | 09/12/2018 | |
Oraverse (phentolamine mesylate) | Oraverse Safety Review | 09/12/2018 | |
Pancreaze & Pertzye (pancrelipase) | Pancreaze & Pertzye Safety Review | 09/12/2018 | |
Pleximmune™ in-vitro diagnostic test (HDE) | Pleximmune™2018 Executive Summary | 09/12/2018 | |
PulseRider Aneurysm Neck Reconstruction Device (HDE) | PulseRider 2018 Executive Summary | 09/12/2018 | |
Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) | Quadracel Safety Review | 09/12/2018 | |
Renvela (sevelamer carbonate) | Renvela Safety Review | 09/12/2018 | |
Zomig Nasal Spray (zolmitriptan) | Zomig Nasal Spray Safety Review | 09/12/2018 | |
Aczone (dapsone) gel, 7.5% | Aczone Safety Review | 03/28/2019 | |
Adynovate | Adynovate Safety Review | 03/28/2019 | |
AirDuo RespiClick (fluticasone propionate and salmeterol xinafoate) ArmonAir R | AirDuo Respiclick and ArmonAir Respiclick Safety Review | 03/28/2019 | |
Avelox (moxifloxacin, tablets and injection) | Avelox Safety Review | 03/28/2019 | |
Caldolor (ibuprofen) IV injection | Caldolor Safety Review | 03/28/2019 | |
Cubicin® and Cubicin® RF (daptomycin for injection) | Cubicin Safety Review | 03/28/2019 | |
Dexilant, Dexilant SoluTab (dexlansoprazole) | Dexilant Safety Review | 03/28/2019 | |
Epicel (cultured epidermal autografts) | Epicel 2019 Executive Summary | 03/28/2019 | |
Eucrisa (crisaborole) ointment, 2% | Eucrisa Safety Review | 03/28/2019 | |
Flourish™ Pediatric Esophageal Atresia Device | Flourish 2019 Executive Summary | 03/28/2019 | |
IXINITY [Coagulation Factor IX (Recombinant)] | IXINITY Safety Review | 03/28/2019 | |
Liletta (levonorgestrel-releasing intrauterine system) | Liletta Safety Review | 03/28/2019 | |
Liposorber® LA-15 System | Liposorber 2019 Executive Summary | 03/28/2019 | |
Lyrica (pregabalin) | Lyrica Safety Review | 03/28/2019 | |
Medtronic Activa Neurostimulator for Dystonia Treatment | Medtronic Activa 2019 Executive Summary | 03/28/2019 | |
Narcan (naloxone) nasal spray | Narcan Safety Review | 03/28/2019 | |
Ofirmev (acetaminophen) injection | Ofirmev Safety Review | 03/28/2019 | |
Selzentry (maraviroc) | Selzentry Safety Review | 03/28/2019 | |
Spiriva Respimat (tiotropium bromide) | Spiriva Safety Review | 03/28/2019 | |
Symbicort (budesonide/ formoterol fumarate dihydrate) | Symbicort Safety Review | 03/28/2019 | |
Tarceva™ (erlotinib) | Tarceva Safety Review | 03/28/2019 | |
Velcade® (bortezomib) | Velcade Safety Review | 03/28/2019 | |
Ativan injection (lorazepam injection) | Ativan Pediatric Safety Review | 09/19/2019 | |
Calcium gluconate injection (calcium gluconate) | Calcium Gluconate Pediatric Safety Review | 09/19/2019 | |
Cerebyx® (fosphenytoin sodium) | Cerebyx® Pediatric Safety Review | 09/19/2019 | |
Contegra Pulmonary Valved Conduit (Humanitarian Device Exemption [HDE]) | Contegra 2019 Executive Summary | 09/19/2019 | |
Dotarem (gadoterate meglumine) | Dotarem Pediatric Safety Review | 09/19/2019 | |
E-Z-HD (barium sulfate) | Barium Sulfate Pediatric Safety Review | 09/19/2019 | |
Elana Surgical Kit (HDE) | Elana Surgical Kit 2019 Executive Summary | 09/19/2019 | |
Enterra Therapy System (HDE) | Enterra Therapy System 2019 Executive Summary | 09/19/2019 | |
Fycompa oral tablets and suspension (perampanel) | Fycompa Pediatric Safety Review | 09/19/2019 | |
Gammaplex - Immune Globulin Intravenous (Human) 5% Liquid | Gammaplex Safety and Utilization Review | 09/19/2019 | |
Harvoni (ledipasvir and sofosbuvir) | Harvoni Pediatric Safety Review | 09/19/2019 | |
Isentress and Isentress HD (raltegravir) | Isentress and Isentress HD Pediatric Safety Review | 09/19/2019 | |
Latuda (lurasidone hydrochloride) | Latuda Pediatric Safety Review | 09/19/2019 | |
Liquid E-Z-Paque (barium sulfate) | Barium Sulfate Pediatric Safety Review | 09/19/2019 | |
NUWIQ® (simoctocog alfa) | NUWIQ® Safety and Utilization Review | 09/19/2019 | |
Pleximmune™ in-vitro diagnostic test (HDE) | Pleximmune™ 2019 Executive Summary | 09/19/2019 | |
PulseRider Aneurysm Neck Reconstruction Device (HDE) | PulseRider 2019 Executive Summary | 09/19/2019 | |
Rapivab® (peramivir) | Rapivab® Pediatric Safety Review | 09/19/2019 | |
Readi-Cat 2, Readi-Cat 2 smoothies (barium sulfate) | Barium Sulfate Pediatric Safety Review | 09/19/2019 | |
Ryzodeg 70/30 (insulin degludec and insulin aspart injection) for subcutaneous u | Ryzodeg Pediatric Safety Review | 09/19/2019 | |
Simponi (golimumab SC), Simponi Aria (golimumab IV) | Simponi Pediatric Safety Review | 09/19/2019 | |
Sovaldi (sofosbuvir) | Sovaldi Pediatric Safety Review | 09/19/2019 | |
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) | Stribild Pediatric Safety Review | 09/19/2019 | |
TACHOSIL (Fibrin Sealant Patch) | TACHOSIL Safety and Utilization Review | 09/19/2019 | |
Tresiba (insulin degludec injection) for subcutaneous use, 100 units/mL (U-100) i | Tresiba Pediatric Safety Review | 09/19/2019 | |
Varibar pudding (barium sulfate) | Barium Sulfate Pediatric Safety Review | 09/19/2019 | |
Vigamox (moxifloxacin hydrochloride ophthalmic solution 0.5%) | Vigamox Pediatric Safety Review | 09/19/2019 | |
Visipaque injection (iodixanol) | Visipaque Pediatric Safety Review | 09/19/2019 | |
WILATE (von Willebrand Factor/ Coagulation Factor VIII Complex (Human)) | WILATE Safety and Utilization Review | 09/19/2019 | |
Zemplar (paricalcitol) | Zemplar Pediatric Safety Review | 09/19/2019 | |
Zymar® 0.3% (gatifloxacin ophthalmic solution) | Zymar® Pediatric Safety Review | 09/19/2019 | |
AFSTYLA (antihemophilic factor (recombinant), single chain) | AFSTYLA Safety and Utilization Review | 07/13/2020 | |
Butrans (buprenorphine transdermal system) | Butrans Pediatric Safety and Utilization Review | 07/13/2020 | |
DraxImage DTPA (technetium TC-99m pentetate kit) injection and inhalation | DraxImage DTPA Pediatric Safety Review | 07/13/2020 | |
Dysport (AbobotulinumtoxinA) | Dysport Pediatric Safety Review | 07/13/2020 | |
Epicel (cultured epidermal autografts) | Epicel 2020 Executive Summary | 07/13/2020 | |
KOVALTRY (antihemophilic factor (recombinant)) | KOVALTRY Safety and Utilization Review | 07/13/2020 | |
Liposorber® LA-15 System (HDE) | Liposorber® LA-15 System 2020 Executive Summary | 07/13/2020 | |
Lumason (sulfur hexafluoride lipid-type A microspheres) injectable suspension | Lumason Pediatric Safety Review | 07/13/2020 | |
Medtronic Activa® Dystonia Therapy (HDE) | Medtronic Activa® Dystonia Therapy 2020 Executive Summary | 07/13/2020 | |
Omidria (phenylephrine and ketorolac intraocular solution) | Omidria Pediatric Safety Review | 07/13/2020 | |
Stelara (ustekinumab) injection | Stelara Pediatric Safety Review | 07/13/2020 | |
Symfi Lo™ (efavirenz 400mg + lamivudine 300mg + tenofovir disoproxil fumarate | Symfi Lo™ and Symfi™ Pediatric Safety Review | 07/13/2020 | |
Canasa (mesalamine suppositories for rectal use) | Canasa Pediatric Safety Review | 09/01/2020 | |
Contegra Pulmonary Valved Conduit (HDE) | Contegra Pulmonary Valved Conduit Executive Summary | 09/01/2020 | |
Descovy® (emtricitabine and tenofovir alafenamide) | Descovy® Pediatric Safety Review | 09/01/2020 | |
Elana Surgical Kit (HDE) | Elana Surgical Kit Executive Summary | 09/01/2020 | |
Enterra Therapy System (HDE) | Enterra Therapy System Executive Summary | 09/01/2020 | |
Flucelvax (influenza vaccine) | Flucelvax Safety and Utilization Review | 09/01/2020 | |
Flucelvax Quadrivalent (influenza vaccine) | Flucelvax Quadrivalent Safety and Utilization Review | 09/01/2020 | |
FluLaval (influenza vaccine) | FluLaval Safety and Utilization Review | 09/01/2020 | |
FluLaval Quadrivalent (influenza vaccine) | FluLaval Quadrivalent Safety and Utilization Review | 09/01/2020 | |
Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir | Genvoya® Pediatric Safety Review | 09/01/2020 | |
Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] | Hiberix Safety and Utilization Review | 09/01/2020 | |
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted | Influenza A (H5N1) Virus Monovalent Vaccine Safety and Utilization Review | 09/01/2020 | |
Lumify (brimonidine tartrate) OTC | Lumify Pediatric Safety Review | 09/01/2020 | |
Luzu (luliconazole) cream, 1% | Luzu Pediatric Safety Review | 09/01/2020 | |
Pleximmune™ in-vitro diagnostic test (HDE) | Pleximmune™ in-vitro diagnostic test Executive Summary | 09/01/2020 | |
PulseRider Aneurysm Neck Reconstruction Device (HDE) | PulseRider Aneurysm Neck Reconstruction Device Executive Summary | 09/01/2020 | |
Sensipar (cinacalcet) | Sensipar Pediatric Safety Review | 09/01/2020 | |
Triumeq (abacavir, dolutegravir, and lamivudine) | Triumeq Pediatric Safety Review | 09/01/2020 | |
Xepi (ozenoxacin) | Xepi Pediatric Safety Review | 09/01/2020 | |
Aptiom (eslicarbazepine acetate) | Aptiom Pediatric Postmarketing Pharmacovigilance Review | 04/26/2021 | |
Cotempla XR-ODT (methylphenidate extended release orally disintegrating tabl | Cotempla Pediatric Postmarketing Pharmacovigilance Review | 04/26/2021 | |
Cuvitru, Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution | Cuvitru Safety and Utilization Review | 04/26/2021 | |
Epicel (cultured epidermal autografts) | Epicel Safety Update | 04/26/2021 | |
JIVI (Antihemophilic Factor (Recombinant), PEGylated-aucl) | JIVI Safety and Utilization Review | 04/26/2021 | |
Liposorber® LA-15 System | Liposorber® LA-15 System Executive Summary | 04/26/2021 | |
Medtronic Activa® Dystonia Therapy (HDE) | Medtronic Activa® Dystonia Therapy Executive Summary | 04/26/2021 | |
Minimally Invasive Deformity Correction (MID-C) System | Minimally Invasive Deformity Correction (MID-C) System Executive Summary | 04/26/2021 | |
Pegasys (peginterferon alpha-2a) | Pegasys Pediatric Postmarketing Pharmacovigiliance Review | 04/26/2021 | |
REBINYN (nonacog beta pegol (N9-GP)) | REBINYN Safety and Utilization Review | 04/26/2021 | |
The Tether™ – Vertebral Body Tethering System | The Tether™ – Vertebral Body Tethering System Executive Summary | 04/26/2021 | |
Vimovo (naproxen/esomeprazole magnesium) | Vimovo Pediatric Postmarketing Pharmacovigilance Review | 04/26/2021 | |
Cialis (tadalafil) | Cialis Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | |
Elana Surgical Kit (HDE) | Elana Surgical Kit Executive Summary | 09/03/2021 | |
Emend (fosaprepitant dimeglumine) | Emend Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | |
Enbrel (etanercept), Erelzi (etanercept-szzs), Eticovo (etanercept-ykro) | Enbrel Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | |
Enterra Therapy System (HDE) | Enterra Therapy System Executive Summary | 09/03/2021 | |
Fasenra (benralizumab) | Fasenra Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | |
Intelence (etravirine) | Intelence Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | |
Medtronic Contegra Pulmonary Valved Conduit (HDE) | Medtronic Contegra Pulmonary Valved Conduit Executive Summary | 09/03/2021 | |
Pleximmune™ in-vitro diagnostic test (HDE) | Pleximmune Executive Summary | 09/03/2021 | |
PulseRider Aneurysm Neck Reconstruction Device (HDE) | PulseRider Aneurysm Neck Reconstruction Device Executive Summary | 09/03/2021 | |
RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) | Rotateq Safety and Utilization Review | 09/03/2021 | |
Rubber Panel T.R.U.E. TEST (Rubber Panel Thin-Layer Rapid Use Epicutaneous Pat | Rubber Panel T.R.U.E. TEST Safety and Utilization Review | 09/03/2021 | |
T.R.U.E. TEST (Thin-Layer Rapid Use Epicutaneous Patch Test) | T.R.U.E. TEST Safety and Utilization Review | 09/03/2021 | |
Tekturna (aliskiren hemifumarate) | Tekturna Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | |
Viread (tenofovir disoproxil fumarate) | Viread Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | |
Xofluza (baloxavir marboxil) | Xofluza Pediatric Postmarketing Pharmacovigilance Review | 09/03/2021 | |
Actemra (tocilizumab) | Actemra Pediatric Postmarketing Pharmacoviligalance Review | 4/19/2022 | |
Activa Dystonia Therapy (none) | Medtronic Activa Neurostimulator for Dystonia Treatment Executive Summary | 4/25/2022 | |
Amitiza (lubiprostone) | Amitiza Pediatric Postmarketing Pharmacovigilance Review | 4/25/2022 | |
Epicel (cultured epidermal autografts) | Epicel (cultured epidermal autografts) Safety Update Memorandum | 4/25/2022 | |
ESPEROCT (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei) | ESPEROCT (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei) Safety Update Memorandum | 4/25/2022 | |
Liposorber LA-15 System (none) | Liposorber LA-15 System Executive Summary | 4/25/2022 | |
Mavyret (glecaprevir/pibrentasvir) | Mavyret (glecaprevir/pibrentasvir) Pediatric Postmarketing Pharmacovigilance Review | 4/25/2022 | |
Minimally Invasive Deformity Correction (MID-C) System (none) | Minimally Invasive Deformity Correction (MID-C) System (none) Executive Summary | 4/25/2022 | |
PANZYGA (Immune Globulin Intravenous, human-ifas) | PANZYGA (Immune Globulin Intravenous, human-ifas) Safety Update Memorandum | 4/25/2022 | |
Pristiq (desvenlafaxine) | Pristiq (desvenlafaxine) Pediatric Postmarketing Pharmacovigilance Review | 4/25/2022 | |
Slynd (drospirenone) | Slynd (drospirenone) Pediatric Postmarketing Pharmacovigilance Review | 4/25/2022 | |
The Tether - Vertebral Body Tethering System (none) | The Tether - Vertebral Body Tethering System (none) Executive Summary | 4/25/2022 | |
Xembify (immune globulin subcutaneous, human – klhw) | Xembify (immune globulin subcutaneous, human – klhw) Safety Update Memorandum | 4/25/2022 | |
Xolair (omalizumab) | Xolair (omalizumab) Pediatric Postmarketing Pharmacovigilance Review | 4/25/2022 | |
Asceniv (Immune Globulin Intravenous (Human), 10% Liquid) | Asceniv (Immune Globulin Intravenous (Human), 10% Liquid) Safety Update Memorandum | 8/18/2022 | |
Benlysta (belimumab) | Benlysta (belimumab) Pediatric Postmarketing Pharmacovigilance Review | 8/18/2022 | |
Contegra (none) | Medtronic Contegra Pulmonary Valved Circuit Models 200 and 200s Executive Summary | 8/18/2022 | |
Enterra Gastric Electrical Stimulator (none) | Enterra Therapy System Executive Summary | 8/18/2022 | |
FIBRYGA (Fibrinogen (Human)) | FIBRYGA (Fibrinogen (Human)) Safety Update Memorandum | 8/18/2022 | |
Flourish Pediatric Esophageal Atresia Device (none) | Flourish Pediatric Esophageal Atresia Device Executive Summary | 8/18/2022 | |
Pleximmune (none) | Pleximmune Executive Summary | 8/18/2022 | |
PulseRider Aneurysm Neck Reconstruction Device (none) | PulseRider Aneurysm Neck Reconstruction Device Executive Summary | 8/18/2022 | |
Sonalleve MR-HIFU (None) | Sonalleve MR-HIFU Executive Summary | 8/18/2022 | |
Vfend (voriconazole) | Vfend (voriconazole) Pediatric Postmarketing Pharmacovigilance Review | 8/18/2022 | |
Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) | Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) Safety Update Memorandum | 8/18/2022 | |
Mavyret (glecaprevir/pibrentasvir) | Mavyret (glecaprevir/pibrentasvir) Pediatric Postmarketing Pharmacovigilance Review | 9/22/2022 | |
Actemra (tocilizumab) | Actemra (tocilizumab) Actemra Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Actemra (tocilizumab) | Actemra (tocilizumab) Actemra Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Activa Dystonia Therapy (none) | Activa Dystonia Therapy Executive Summary | 4/19/2023 | |
AFLURIA; AFLURIA QUADRIVALENT (Influenza Vaccine) | AFLURIA; AFLURIA QUADRIVALENT (Influenza Vaccine) Safety Update Memorandum | 4/19/2023 | |
Altreno lotion (tretinoin) | Altreno lotion (tretinoin) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Arnuity Ellipta (fluticasone furoate) | Arnuity Ellipta (fluticasone furoate) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Astagraf XL (tacrolimus) | Astagraf XL (tacrolimus) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Avycaz (ceftazidime/avibactam) | Avycaz (ceftazidime/avibactam) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Botox (onabotulinumtoxinA) | Botox (onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Botox (onabotulinumtoxinA) | Botox (onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Botox (onabotulinumtoxinA) | Botox (onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Botox injection (onabotulinumtoxinA) | Botox injection (onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Botox injection (onabotulinumtoxinA) | Botox injection (onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Breo Ellipta (fluticasone furoate/vilanterol) | Breo Ellipta (fluticasone furoate/vilanterol) Safety Update Memorandum | 4/19/2023 | |
Briviact (brivaracetam) | Briviact (brivaracetam) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Briviact tablets, solution, and injection (brivaracetam) | Briviact tablets, solution, and injection (brivaracetam) Safety Update Memorandum | 4/19/2023 | |
Clenpiq (sodium picosulfate/magnesium oxide/anhydrous citric acid) | Clenpiq (sodium picosulfate/magnesium oxide/anhydrous citric acid) Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Corlanor Oral Solution (ivabradine) | Corlanor Oral Solution Executive Summary | 4/19/2023 | |
Cystadrops ophthalmic solution (cysteamine) | Cystadrops ophthalmic solution (cysteamine) Safety Update Memorandum | 4/19/2023 | |
Descovy (emtricitabine/tenofovir alafenamide) | Descovy (emtricitabine/tenofovir alafenamide) Safety Update Memorandum | 4/19/2023 | |
Dysport (abobotulinumtoxinA) | Dysport (abobotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Effient (prasugrel) | Effient (prasugrel) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Epicel (cultured epidermal autografts) | Epicel (cultured epidermal autografts) Safety Update Memorandum | 4/19/2023 | |
Fluarix Quadrivalent (Influenza Vaccine) | Fluarix Quadrivalent (Influenza Vaccine) Safety Update Memorandum | 4/19/2023 | |
Fycompa (perampanel) | Fycompa (perampanel) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Granix injection (tbo-filgrastim) | Granix injection (tbo-filgrastim) Safety Update Memorandum | 4/19/2023 | |
Harvoni (ledipasvir/sofosbuvir) | Harvoni (ledipasvir/sofosbuvir) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Jornay PM (methylphenidate) | Jornay PM (methylphenidate) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Katerzia oral suspension (amlodipine benzoate) | Katerzia oral suspension (amlodipine benzoate) Safety Update Memorandum | 4/19/2023 | |
Kerydin topical solution (tavaborole) | Kerydin topical solution (tavaborole) Safety Update Memorandum | 4/19/2023 | |
Liposorber LA-15 System (none) | Liposorber LA-15 System Executive Summary | 4/19/2023 | |
Livalo (pitavastatin) | Livalo (pitavastatin) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Lyrica (pregabalin) | Lyrica (pregabalin) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Minimally Invasive Deformity Correction (MID-C) System (none) | Minimally Invasive Deformity Correction (MID-C) System Executive Summary | 4/19/2023 | |
Prepopik for oral solution (sodium picosulfate/magnesium oxide/anhydrous citric acid) | Prepopik for oral solution (sodium picosulfate/magnesium oxide/anhydrous citric acid) Executive Summary | 4/19/2023 | |
Procysbi (cysteamine bitartrate) | Procysbi (cysteamine bitartrate) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
PulseRider Aneurysm Neck Reconstruction Device (none) | PulseRider Aneurysm Neck Reconstruction Device Safety Update Memorandum | 4/19/2023 | |
Qbrexza cloth (glycopyrronium) | Qbrexza cloth (glycopyrronium) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Seysara (sarecycline) | Seysara (sarecycline) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Sovaldi (sofosbuvir) | Sovaldi (sofosbuvir) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
The Tether - Vertebral Body Tethering System (none) | The Tether - Vertebral Body Tethering System Executive Summary | 4/19/2023 | |
Twyneo cream (tretinoin/benzoyl peroxide) | Twyneo cream (tretinoin/benzoyl peroxide) Safety Update Memorandum | 4/19/2023 | |
Winlevi cream (clascoterone) | Winlevi cream (clascoterone) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Xeomin injection (incobotulinumtoxinA) | Xeomin injection (incobotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Zovirax injection (acyclovir) | Zovirax injection (acyclovir) Pediatric Postmarketing Pharmacovigilance Review | 4/19/2023 | |
Dysport (abobotulinumtoxinA) | Dysport (abobotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review | 6/19/2023 | |
Annovera (segesterone acetate/ethinyl estradiol ) | Annovera (segesterone acetate/ethinyl estradiol ) Safety Update Memorandum | 10/26/2023 | |
Aptensio XR (methylphenidate hydrochloride) | Aptensio XR (methylphenidate hydrochloride) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) | Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) Safety Update Memorandum | 10/26/2023 | |
Contegra (none) | Contegra Pediatric Executive Summary | 10/26/2023 | |
Dificid (fidaxomicin) | Dificid (fidaxomicin) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
Enterra Gastric Electrical Stimulator (none) | Enterra Gastric Electrical Stimulator Executive Summary | 10/26/2023 | |
Epclusa (sofosbuvir/velpatasvir) | Epclusa (sofosbuvir/velpatasvir) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
Epclusa oral pellets (sofosbuvir/velpatasvir) | Epclusa oral pellets (sofosbuvir/velpatasvir) Safety Update Memorandum | 10/26/2023 | |
Flector Topical System (diclofenac epolamine) | Flector Topical System Executive Summary | 10/26/2023 | |
Flourish Pediatric Esophageal Atresia Device (none) | Flourish Pediatric Esophageal Atresia Device Executive Summary | 10/26/2023 | |
Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) | Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) Safety Update Memorandum | 10/26/2023 | |
Jevtana (cabazitaxel) | Jevtana (cabazitaxel) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
Nucala (mepolizumab) | Nucala (mepolizumab) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) | ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Executive Summary | 10/26/2023 | |
Otiprio (ciprofloxacin) | Otiprio (ciprofloxacin) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
Phexxi vaginal gel (lactic acid/citric acid/potassium bitartrate) | Phexxi vaginal gel (lactic acid/citric acid/potassium bitartrate) Executive Summary | 10/26/2023 | |
Pleximmune (none) | Pleximmune (none) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
Promacta (eltrombopag) | Promacta (eltrombopag) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
PulseRider Aneurysm Neck Reconstruction Device (none) | PulseRider Aneurysm Neck Reconstruction Device Executive Summary | 10/26/2023 | |
Saxenda injection (liraglutide) | Saxenda injection (liraglutide) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
Sonalleve MR-HIFU (None) | Sonalleve MR-HIFU Executive Summary | 10/26/2023 | |
Sorilux (calcipotriene) | Sorilux (calcipotriene) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
Tivicay PD tablets for oral suspension (dolutegravir) | Tivicay PD tablets for oral suspension (dolutegravir) Postmarketing Pharmacovigilance Review | 10/26/2023 | |
Tivicay tablets (dolutegravir) | Tivicay tablets (dolutegravir) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) | VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) Safety Update Memorandum | 10/26/2023 | |
Victoza (liraglutide) | Victoza (liraglutide) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
Vimpat (lacosamide) | Vimpat (lacosamide) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
Yondelis injection (trabectedin) | Yondelis injection (trabectedin) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
Zerviate (cetirizine) | Zerviate (cetirizine) Pediatric Postmarketing Pharmacovigilance Review | 10/26/2023 | |
Aczone Gel (dapsone) | Aczone Gel (dapsone) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Adhansia XR (methylphenidate hydrochloride) | Adhansia XR (methylphenidate hydrochloride) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Aklief (trifarotene) | Aklief (trifarotene) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Ampicillin Injection (ampicillin) | Ampicillin Injection (ampicillin) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Amzeeq (minocycline) | Amzeeq (minocycline) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Arazlo (tazarotene) | Arazlo (tazarotene) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Asmanex HFA (mometasone furoate) | Asmanex HFA (mometasone furoate) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Baqsimi nasal powder (glucagon) | Baqsimi nasal powder (glucagon) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Ciloxan ophthalmic solution (ciprofloxacin) | Ciloxan ophthalmic solution (ciprofloxacin) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Conjupri (levamlodipine) | Conjupri (levamlodipine) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Doptelet tablet (avatrombopag) | Doptelet tablet (avatrombopag) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Dulera Inhalation Aerosol (formoterol fumarate/mometasone furoate) | Dulera Inhalation Aerosol Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Dutrebis (lamivudine/raltegravir) | Dutrebis (lamivudine/raltegravir) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Enstilar Foam (calcipotriene/betamethasone dipropionate) | Enstilar Foam (calcipotriene/betamethasone dipropionate) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Gvoke (glucagon) | Gvoke (glucagon) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Jublia topical solution (efinaconazole) | Jublia topical solution (efinaconazole) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Nuvessa (metronidazole) | Nuvessa (metronidazole) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Prezcobix tablets (darunavir/cobicistat) | Prezcobix tablets (darunavir/cobicistat)Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Primatene Mist (epinephrine) | Primatene Mist (epinephrine) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Quzyttir (cetirizine hydrochloride) | Quzyttir (cetirizine hydrochloride) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Sivextro tablet (tedizolid phosphate) | Sivextro tablet (tedizolid phosphate) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Spy Agent Green (Indocyanine green) | Spy Agent Green (Indocyanine green) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Symtuza tablets (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) | Symtuza tablets (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Taclonex (calcipotriene/betamethasone dipropionate) | Taclonex (calcipotriene/betamethasone dipropionate) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Taltz injection (ixekizumab) | Taltz injection (ixekizumab) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Truvada (emtricitabine/tenofovir disoproxil fumarate) | Truvada (emtricitabine/tenofovir disoproxil fumarate) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Vectical ointment (calcitriol) | Vectical ointment (calcitriol) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
VESIcare LS oral suspension (solifenacin succinate) | VESIcare LS oral suspension (solifenacin succinate) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Welchol (colesevelam hydrochloride) | Welchol (colesevelam hydrochloride) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Welchol Chewable Bar (colesevelam HCl) | Welchol Chewable Bar (colesevelam HCl) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 | |
Xtoro (finafloxacin) | Xtoro (finafloxacin) Pediatric Postmarketing Pharmacovigilance Review | 12/21/2023 |
See the Best Pharmaceuticals for Children Act, Pediatric Research Equity Act and Pediatric Medical Device Safety and Improvement Act for more information.
- Pediatric Advisory Recommendations (XLSX, 70KB)
Additional Resources