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Thursday, 5 December 2013

Approved Risk Evaluation and Mitigation Strategies (REMS)

Approved Risk Evaluation and Mitigation Strategies (REMS)

The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.  Additional REMS Information.
The three tables below provide separate lists for: 
    • Currently Approved Shared System REMS
           -- Buprenorphine Transmuscosal Products for Opioid Dependence (BTOD) REMS  
           -- Extended-Release and Long-Acting (ER/LA) Opioid Analgesics REMS  
           -- Isotretinoin iPLEDGE REMS
           -- Mycophenolate REMS
           -- Rosiglitazone REMS  
           -- Transmucosal Immediate-Release Fentanyl (TIRF) Products REMS

 

Currently Approved Individual REMS


Product                                                                            		Application                      Date REMS Approved
REMS Components
(All REMS include timetable for assessment)  
Actemra (tocilizumab) Injection (PDF - 1MB)                               BLA 125276/92; 1254721/8/2010;
modified 4/15/2011, 6/20/2012, 10/11/2012, 4/29/2013, 7/2/2013, 10/21/2013		communication                 plan                           
Adasuve (loxapine) Inhalation Powder (PDF - 3.5MB) NDA 22-54912/21/2012communication plan, elements to assure safe use, implementation system
Adempas (riociguat) Tablets (PDF - 6MB) NDA 20481910/8/2013medication guide, elements to assure safe use, implementation system
Androgel (testosterone) 1% Gel (PDF - 96KB) NDA 21-015/S-0369/18/2009; modified 3/10/2011, 11/30/2011, 5/20/2013medication guide
Androgel (testosterone) 1.62% Gel (PDF - 95KB) NDA 22-309/S-0084/29/2011; modified 9/7/2012, 5/20/2013 medication guide
Aranesp (darbepoetin alfa) Injection (PDF - 10MB) BLA 103951/53372/16/2010; modified 6/24/2011, 5/31/2012, 3/27/2013medication guide, communication plan,
elements to assure safe use,
implementation system
Axiron (testosterone) Topical Solution (PDF - 37KB) NDA 22-504/S-00211/23/2010; modified 3/31/2011medication guide
Bydureon (exenatide) Extended-Release for Injectable Suspension (PDF - 116KB)  NDA 22-2001/27/2012communication plan
Caprelsa (vandetanib) Tablets (PDF - 6MB)NDA 22-405/S-0014/6/2011; modified
6/22/2011		medication guide, communication plan, elements to assure safe use, implementation system
Chantix (varenicline) Tablets (PDF - 17KB) NDA 21-928/S-019, S-020, S-2110/19/2009; modified 4/22/2010, 7/22/2011medication guide
Eliquis (apixaban) Tablets (PDF - 280KB) NDA 20215512/28/2012communication plan
Entereg (alvimopan) Capsules (PDF - 424KB) NDA 21-775/S-0105/20/2008
modified 2/5/2009, 9/25/2012, 10/18/2013		elements to assure safe use, implementation system
Epogen/Procrit (epoetin alfa) Injection (PDF - 10MB)   BLA 103234/53292/16/2010; modified 6/24/2011, 5/31/2012, 3/27/2013medication guide, communication plan, elements to assure safe use, implementation system
Extraneal (icodextrin) Intraperitoneal Solution (PDF - 2411KB) NDA 21-321/S-020, S-0213/8/2011medication guide, elements to assure safe use, implementation system
Forteo (teriparatide [rDNA origin]) Injection (PDF - 254KB)  NDA 21-318/S-0277/22/2009; modified 3/13/2012medication guide, communication plan
Fortesta (testosterone) Gel (PDF - 37KB) NDA 21-463/S-01012/29/2010; modified 9/11/2013medication guide
Gattex (teduglutide [rDNA origin]) Injection (PDF - 1.3MB) NDA 20344112/21/2012communication plan, elements to assure safe use
Gilenya (fingolimod) Capsules (PDF - 473KB)  NDA 22-527/S-0109/21/2010; modifed 3/1/2012, 5/28/2013communication plan
Juxtapid (lomitapide) Capsules (PDF - 5MB) NDA 203858/S-00112/21/2012; modified 8/13/2013elements to assure safe use, implementation system
Krystexxa (pegloticase) Injection (PDF - 854KB)  BLA 125293/609/14/2010; modified 10/19/2010, 4/16/2012. 10/10/2013communication plan
Kynamro (mipomersen sodium) (PDF - 15MB) NDA 2035681/29/2013elements to assure safe use, implementation system
Letairis (ambrisentan) Tablets (PDF - 2MB) NDA 22-081/S-0195/29/2009; modified 7/1/2009,
8/5/2009, 8/24/2010, 10/13/2010, 3/3/2011, 2/15/2012, 10/19/2012, 8/17/2013		medication guide, elements to assure safe use, implementation system
Lotronex (alosetron hydrochloride) Tablets (PDF - 18MB)NDA 21-107/S-0149/2/2010medication guide, elements to assure safe use, implementation system
Lumizyme (alglucosidase alfa) (PDF - 848KB) BLA 125291/795/24/2010; modified 9/12/2011, 7/16/2012communication plan, elements to assure safe use, implementation system
Metoclopramide Oral Solution (PDF - 31KB)ANDA 74-703/S-0079/15/2009medication guide
Metoclopramide Oral Solution (PDF - 24KB)ANDA 72-744/S-0119/15/2009medication guide
Metoclopramide Oral Solution (PDF - 24KB)ANDA 71-402/S-0089/16/2009medication guide
Mifeprex (mifepristone) Tablets (PDF - 205KB) NDA 20-687/S-0146/8/2011medication guide, elements to assure safe use, implementation system
Multaq (dronedarone) Tablets (PDF - 111KB)  NDA 22-425/S-016, S-017, S-0187/1/2009; modified 2/11/2011, 8/5/2011, 6/13/2012, 9/7/2012medication guide, communication plan
Nplate (romiplostim) for Subcutaneous Injection (PDF - 45KB)  BLA 125268/778/22/2008; modified 8/14/2009, 3/23/2010, 7/29/2011, 12/6/2011communication plan
Nulojix (belatacept) (PDF -  946KB) BLA 1252886/15/2011medication guide, communication plan
Omontys (peginesatide) Injection (PDF - 165KB)  NDA 2027993/27/2012communication plan
Opsumit (macitentan) Tablets (PDF - 4MB) NDA 20441010/18/2013medication guide, elements to assure safe use, implementation system
Pomalyst (pomalidomide) Capsules (PDF - 12MB) NDA 2040262/8/2013elements to assure safe use, implementation system
Potiga (ezogabine) Tablets (PDF - 524KB)  NDA 22-345/S-0016/10/2011; modified 3/19/2012communication plan
Prolia (denosumab) Injection (PDF - 41KB)  BLA 125320/1136/1/2010; modified 9/16/2011, 5/10/2012, 7/3/2013medication guide, communication plan
Promacta (eltrombopag) Tablets (PDF - 225KB)  NDA 22-291/S-00611/20/2008; modified 3/5/2010, 2/25/2011, 12/6/2011communication plan
Qsymia (phentermine and topiramate) Extended-Release Capsules (PDF - 5MB)  NDA 22-580/S-0047/17/2012; modified 11/1/2012, 4/16/2013medication guide, elements to assure safe use, implementation system
Revlimid (lenalidomide) Capsules (PDF - 11MB)  NDA 21-880/S-0348/3/2010; modified 5/9/2012, 2/8/2013, 6/5/2013elements to assure safe use, implementation system
Sabril (vigabatrin) Oral Solution (PDF - 1.9MB) Updated!NDA 22-006/S-011, S-012, S-0138/21/2009; modified 1/18/2011, 12/11/2012, 10/26/2013medication guide, communication plan, elements to assure safe use, implementation system
Sabril (vigabatrin) Tablets (PDF - 1.9MB) Updated!NDA 20-427/S-010, S-011, S-0128/21/2009; modified 1/18/2011, 12/11/2012, 10/26/2013medication guide, communication plan, elements to assure safe use, implementation system
Soliris (eculizumab) Injection (PDF - 3MB)BLA 125166/1726/4/2010; modified 9/23/2011medication guide, elements to assure safe use
Stelara (ustekinumab) Injection (PDF - 314KB)
 		BLA 125261/1039/25/2009;  modified 12/30/2009, 10/20/2010, 5/2/2012, 9/20/2013communication plan
Suboxone (buprenorphine and naloxone) Sublingual Film (PDF - 960KB)NDA 22-4108/30/2010medication guide, elements to assure safe use, implementation system
Suboxone (buprenorphine and naloxone) Sublingual Tablets (PDF - 455KB)  NDA 22-733/S-007, S-00812/22/2011medication guide, elements to assure safe use, implementation system
Subutex (buprenorphine) Sublingual Tablets (PDF - 467KB)  NDA 20-732/S-006, S-00712/22/2011medication guide, elements to assure safe use, implementation system
Tapentadol Tablets (PDF - 222KB)NDA 22-30411/20/2008medication guide
Testim (testosterone) Gel (PDF - 35KB)  NDA 21-454/S-0149/18/2009; modified 11/22/2011medication guide
Testosterone Gel (PDF - 13KB)  NDA 2027632/14/2012medication guide
Thalomid (thalidomide) Capsules (PDF - 7MB) NDA 20-785/S-0488/3/2010; modified 2/8/2013elements to assure safe use, implementation system
Tikosyn (dofetilide) Capsules (PDF - 2MB)  NDA 20-931/S-0037/11/2011medication guide, elements to assure safe use, implementation system
Tracleer (bosentan) Tablets (PDF - 3MB) NDA 21-290/S-0258/7/2009; modified 2/19/2010, 10/2/2012, 7/1/2013medication guide, elements to assure safe use, implementation system
Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets (PDF - 9MB)  NDA 21-752/S-0357/16/2012; modified 6/17/2013medication guide, elements to assure safe use
Tysabri (natalizumab) Intravenous Injection (PDF - 10MB)  BLA 125104/83110/7/2011; modified 1/20/2012, 5/24/2013medication guide, elements to assure safe use, implementation system
Versacloz (clozapine) Oral Suspension (PDF - 1MB) NDA 2034792/6/2013elements to assure safe use, implementation system
Vibativ (telavancin) Injection (PDF - 94KB)  NDA 22-110/S-003; 22-4079/11/2009; modified 7/27/2011, 6/21/2013medication guide, communication plan
Victoza (liraglutide) Injection (PDF - 1025KB) NDA 22-341/S-0041/25/2010; modified 5/18/2011communication plan
Vivitrol (naltrexone) Extended-Release Injectable Suspension (PDF - 756KB) NDA 21-897/S-020, S-0233/22/2010; modified 10/12/2010, 7/29/2013medication guide, communication plan
 
Xarelto (rivaroxaban) Tablets (PDF - 499KB)  NDA 202439/S-00811/4/2011; modified 7/12/2012, 8/7/2013communication plan
Xeljanz (tofacitinib) Tablets (PDF - 161KB) Updated!NDA 203214/S-00611/6/2012; modified 11/8/2013medication guide, communication plan
Xenazine (tetrabenazine) Tablets (PDF - 2MB) NDA 21-894/S-0098/15/2008; modified 12/1/2009, 5/4/2011, 8/17/2012, 8/2/2013communication plan
Xiaflex (collagenase clostridium histolyticum) Injection (PDF - 2MB)  BLA 125338/402/2/2010; modifed 2/24/2012communication plan
Yervoy (ipilimumab) Injection (PDF - 3MB)  BLA 125377/163/25/2011; modified 2/16/2012communication plan
Zyban (bupropion hydrochloride) Sustained-Release Tablets (PDF - 19KB)NDA 20-711/S-0342/26/2010medication guide
Zyprexa Relprevv (olanzapine) Extended-Release Injection (PDF - 3MB) NDA 22-173/S-01812/11/2009; modified 7/8/2010, 8/3/2012, 3/27/2013medication guide, communication plan, elements to assure safe use, implementation system

Currently Approved Shared System REMS 
 

Name of Shared System REMS (and included products)                                     Date REMS Approved
REMS Components
(All REMS include timetable for assessment)
2/22/2013;
modifed
9/4/2013 		medication guide,
elements to assure safe use,
implementation system 
7/9/2012; modified 8/28/2012, 4/15/2013medication guide,
elements to assure safe use
10/22/2010; modified 4/12/2012    medication guide,
elements to assure safe use,
implementation system                  
9/25/2012;
modified
9/27/2013 

medication guide,
elements to assure safe use
1/25/2013medication guide,
elements to assure safe use, implementation system
  • List of application numbers and sponsors (PDF - 17KB) (updated 11/1/2013)  Updated!
    • Abstral (fentanyl) Sublingual Tablets
    • Actiq (fentanyl citrate) Oral Transmucosal Lozenge and the generic equivalents
    • Fentora (fentanyl citrate) Buccal Tablets
    • Lazanda (fentanyl) Nasal Spray 
    • Onsolis (fentanyl) Buccal Soluble Film
    • Subsys (fentanyl) Sublingual Spray
12/28/2011;
modified
6/5/2012,
11/7/2013		medication guide,
elements to assure safe use,
implementation system 
 

 

 

Released REMS 
   

                                                                                            
 Product                                                       
Date Released from REMS Requirement
Actonel (risedronate sodium) Tablets  8/22/2011
Actonel with Calcium (risedronate sodium and calcium carbonate) Tablets  8/22/2011
Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets  5/17/2012
Actoplus Met XR (pioglitazone and metformin) Extended-Release Tablets  5/17/2012
Actos (pioglitazone hydrochloride) Tablets  5/17/2012
Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder) 8/9/2012
Advair HFA (fluticasone propionate and salmeterol xinafoate inhalation powder) 8/9/2012
Ampyra (dalfampridine) Extended-Release Tablets 6/18/2013
Aplenzin (buproprion hydrobromide) Extended-Release Tablets  4/29/2011
Arcapta Neohaler (indacaterol maleate) Inhalation Powder 12/18/2012
Atelvia (risedronate sodium) Delayed-Release Tablets   8/22/2011
Avelox (moxifloxacin) Tablets and I.V. Solution  8/3/2011
Banzel (rufinamide) Tablets and Oral Suspension  6/10/2011
Boniva (ibandronate sodium) Injection  7/1/2011
Boniva (ibandronate sodium) Tablets7/1/2011
Botox/Botox Cosmetic (onabotulinumtoxinA) Injection  7/16/2012
Brilinta (ticagrelor) Tablets  Updated!10/30/2013
Brovana (arformoterol tartrate) Inhalation Solution 8/9/2012
Byetta (exanatide) Injection  8/5/2011
Cambia (diclofenac potassium) Oral Solution  7/20/2011
Carbatrol (carbamazepine) Extended-Release Capsules   8/22/2011
Celontin (methsuximide) Capsules  6/15/2011
Cimzia (certolizumab pegol) Lyophilized powder for solution for subcutaneous injection 7/26/2011
Cipro (ciprofloxacin) Tablets, Oral Suspension, I.V. Solution , and Extended-Release Tablets8/3/2011
Colcrys (colchicine) Tablets  7/20/2011
Colcrys (colchicine) Tablets  7/20/2011
Colcrys (colchicine) Tablets 7/20/2011
Copegus (ribavirin) Tablets   5/9/2011
Creon (pancrelipase) Delayed-Release Capsules  5/9/2011
Dilantin (phenytoin) Oral Suspension  5/27/2011
Duetact (pioglitazone hydrochloride and glimepiride) Tablets  5/17/2012
Dulera (mometasone furoate and formoterol fumarate) Inhalation Aerosol 11/27/2012
Dysport (abobotulinumtoxinA) Injection 5/22/2012
Edluar (zolpidem tartrate) Sublingual Tablets8/10/2011
Effient (prasugrel) Tablets  3/23/2012
Enbrel (etanercept) for Subcutaneous Injection  8/10/11
Epzicom (abacavir sulfate and lamivudine) Tablets  5/13/2011
Equetro (carbamazepine) Extended-Release Capsules   1/27/2012
Extavia (interferon beta-1b)  6/22/2011
Factive (gemifloxacin) Tablets 8/4/2011
Foradil (formoterol fumarate) Inhalation Powder 3/29/2013
Fosamax (alendronate sodium) Oral Solution and Tablets  7/1/2011
Fosamax Plus D (alendronate sodium and cholecalciferol) Tablets  7/1/2011
Gabitril (tiagabine hydrochloride) Tablets  1/25/2012
Gralise (gabapentin) Tablets  4/28/2011
HalfLytely Bisacodyl Bowel Prep Kit (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride)7/6/2011
H.P. Acthar Gel (repository corticotropin) Injection 7/5/2012
Humira (adalimumab) Injection 12/13/2011
Infergen (interferon alfacon-1)  6/1/2011
Intron A (interferon alfa-2b)  5/13/2011
Invirase (saquinavir mesylate) Capsules and Tablets  5/26/2011
Janumet (sitagliptin/metformin) Tablets 4/14/2011
Januvia (sitagliptin) Tablets  4/14/2011
Kalbitor (ecallentide) Injection 4/10/2013
Kaletra (lopinavir and ritonavir) Tablets and Oral Solution  
5/6/2011
Keppra, Keppra XR (levetiracetam) Tablets, Extended-Release Tablets, Oral Solution, and Injection   8/10/2011
Ketek (telithromycin) Tablets6/20/2011
Klonopin (clonazepam) Tablets and Orally Disintegrating Tablets  11/29/2011
Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, and Orally Disintegrating Tablets (ODT)  5/31/2011
Lamictal XR (lamotrigine) Extended-Release Tablets4/25/2011
Lariam (mefloquine hydrochloride) Tablets  4/29/2011
Levaquin (levofloxacin) Tablets, Injection, and Oral Solution  10/7/2011
Lyrica (pregabalin) Capsules and Oral Solution  
4/26/2011
Metoclopramide Oral Solution (ANDA 73-680)  3/14/2012
Metozolv ODT (metoclopramide hydrochloride) Orally Disintegrating Tablets  8/22/2011
Morphine Sulfate Oral Solution10/18/2011
Myobloc (rimabotulinumtoxinB) Injection  6/13/2012
Mysoline (primidone) Tablets   8/10/2011
Neurontin (gabapentin) Capsules, Tablets, and Oral Solution  8/10/2011
Noroxin (norfloxacin) Tablets 9/8/2011
Nuvigil (armodafinil) Tablets   1/13/2012
Oleptro (trazadone hydrochloride) Extended-Release Tablets  5/11/2011
Osmoprep (sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrate) Tablets12/9/2011
Oxycodone Hydrochloride Oral Solution 1/25/2012
Pancreaze (pancrelipase) Delayed-Release Capsules6/20/2011
Peganone (ethotoin) Tablets 5/31/2011
Pegasys (peginterferon alfa-2a)5/9/2011
PegIntron (peginterferon alfa-2b)  5/13/2011
PegIntron Rebetol Combopack (peginterferon alfa-2b, Redipen Single-dose Delivery System and Rebetol ribavirin) 8/18/2009
Pennsaid (diclofenac sodium) Topical Solution  7/14/2011
Plavix (clopidogrel bisulfate) Tablets  5/3/2011
Perforomist (formoterol fumarate) Inhalation Solution 9/25/2012
Pradaxa (dabigatran etexilate mesylate) Capsules  
4/5/2011
Propylthiouracil (propylthiouracil) Tablets  7/27/2011
Proquin XR (ciprofloxacin) Extended-Release Tablets  8/15/2011
Provigil (modafinil) Tablets   1/13/2012
Qualaquin (quinine sulfate) Capsules  5/22/2012
Rapamune (sirolimus) Oral Solution and Tablets  6/6/2011
Rebetol (ribivarin) Capsules and Oral Solution  4/19/2011
Reclast (zoledronic acid) Injection  8/15/2011
Reglan ODT (metoclorpramide hydrochloride) Orally Disintegrating Tablets  8/2/2011
Reglan (metoclopramide hydrochloride) Tablets  8/2/2011
Regranex (becaplermin)4/30/2012
Remicade (infliximab) Vial  8/1/2011
Roferon-A Interferon (alfa-2a, recombinant) Injection  6/16/2011
Rozerem (ramelteon) Tablets   8/4/2011
Samsca (tolvaptan) Tablets 9/14/2012
Savella (milnacipran hydrochloride) Tablets 
4/26/2011
Serevent Diskus (salmeterol xinafoate) Inhalation Powder 8/9/2012
Seroquel (quetiapine) Tablets11/9/2011
Seroquel XR (quetiapine) Extended-Release Tablets   11/9/2011
Silenor (doxepin) Tablets 10/30/2011
Simponi (golimumab) Injection 3/17/2011
Sucraid (sacrosidase) Oral Solution 12/9/2010
Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) Oral Solution  7/6/2011
Sutent (sunitinib) Capsules  5/19/2011
Symbicort (budesonide and formoterol) Inhalation Aerosol  7/23/2012
Symbyax (olanzapine and fluoxetine) Capsules  6/21/2011
Tasigna (nilotinib) Capsules 5/17/2013
Tegretol and Tegretol-XR (carbemazepine) Tablets, ChewableTablets, Suspension, and Extended-Release Tablets  10/30/2011
Topamax (topiramate) Tablets and Sprinkle Capsules  6/27/2011
Tranxene (clorazepate dipotassium) Tablets 7/19/2011
Treximet (sumatriptan succinate and naproxen sodium) Tablets  9/23/2011
Trileptal (oxcarbazepine) Tablets and Suspension  10/30/2011
Trilipix (fenofibric acid) Delayed-Release Capsules  9/30/2011
Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets  5/13/2011
Tyzeka (telbivudine) Oral Solution 5/5/2011
Tyzeka (telbivudine) Tablets  5/5/2011
Venlafaxine hydrochloride Extended- Release Tablets  7/31/2012
Videx, Videx EC (didanosine) Delayed-Release Capsules and Oral Solution 5/10/2011
Viibryd (vilazodone hydrochloride) Tablets  6/29/2011
Vimpat (lacosamide) Injection, Oral Solution, and Tablets  8/10/2011
Viramune (nevirapine) Tablets, Oral Suspension, and Extended-Release Tablets  5/6/2011
Visicol (sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrate)Tablets 12/9/2011
Votrient (pazopanib) Tablets   4/21/2011
Wellbutrin, Wellbutrin SR (bupropion hydrochloride) Tablets and Sustained-Release Tablets 8/2/2012
Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets 8/2/2012
Xeomin (incobotulinumtoxinA) Injection  7/16/2012
Xolair (omalizumab) Injection  12/22/2011
Zarontin (ethosuximide) Capsules 6/15/2011
Zenpep (pancrelipase) Delayed-Release Capsules6/10/2011
Zerit (stavudine) Capsules and Oral Solution5/11/2011
Ziagen (abacavir sulfate) Tablets and Oral Solution5/13/2011
Zipsor (diclofenac potassium) Capsules5/4/2011
Zolpimist (zolpidem tartrate) Oral Spray9/28/2011
Zonegran (zonisamide) Capsules5/27/2011
Zortress (everolimus) Tablets  5/2/2012
Zyprexa, Zyprexa Zydis (olanzapine) Tablets6/21/2011

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Alert for Healthcare Professionals: Aripiprazole (marketed as Abilify)

Alert for Healthcare Professionals: Aripiprazole (marketed as Abilify)


9/2006: The issue described in this alert has been addressed in product labeling.  For current information, see Atypical Antipsychotic Drugs.

FDA Alert [4/11/2005]: Increased Mortality in Patients with Dementia-Related Psychosis
FDA has determined that patients with dementia-related psychosis treated with atypical (second generation) antipsychotic medications are at an increased risk of death compared to placebo. Based on currently available data, FDA has requested that the package insert for Abilify be revised to include a black box warning describing this risk and noting that this drug is not approved for this indication.
This information reflects FDA’s current analysis of all available data concerning this drug. FDA intends to update this page when additional information or analyses become available.
To report any unexpected adverse or serious events associated with the use of Abilify, please contact the FDA MedWatch program using the contact information at the bottom of this page.
Data Summary
  • Analyses of seventeen placebo controlled trials that enrolled 5106 elderly patients with dementia related behavioral disorders revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Clinical trials were performed with Zyprexa (olanzapine), Abilify (aripiprazole), Risperdal (risperidone), and Seroquel (quetiapine). Over the course of these trials averaging about 10 weeks in duration, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
Report serious adverse events to FDA's MedWatch either online, by regular mail or by fax, using the contact information at the bottom of this page.
Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-796-3400
Druginfo@fda.hhs.gov
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Information for Healthcare Professionals: Olanzapine/fluoxetine (marketed as Symbyax)

Information for Healthcare Professionals: Olanzapine/fluoxetine (marketed as Symbyax)

Update: The issues described in this communication have been addressed in product labeling (see Drugs@FDA).
   
FDA ALERTS:
       
FDA ALERT [7/2006]: Increased Risk of Neonatal Persistent Pulmonary Hypertension
A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy (see SSRI drug names at the bottom of this sheet). The background risk of a woman giving birth to an infant affected by PPHN in the general population is estimated to be about 1 to 2 infants per 1000 live births. Neonatal PPHN is associated with significant morbidity and mortality. The FDA is updating the prescribing information for all SSRIs with this new information. The FDA is also accruing data from additional sources pertaining to the potential association between SSRIs and neonatal PPHN. The FDA will provide additional information when it becomes available. In the interim, the FDA recommends that physicians carefully consider and discuss with patients the potential risks and benefits of SSRI treatment throughout pregnancy, including late pregnancy.
This information reflects FDA’s current analysis of data available to FDA concerning these drugs. FDA intends to update this sheet when additional information or analyses become available.
To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program aeither online, by regular mail or by fax, using the contact information at the bottom of this page.
Considerations

Physicians should consider the benefits and risks of treating pregnant women with SSRIs, alternative treatments, or no treatment late in pregnancy.

Data Summary

A retrospective case-control study published on February 9, 2006, in the New England Journal of Medicine assessed the risk for persistent pulmonary hypertension of the newborn (PPHN) following exposure to SSRIs during pregnancy. 377 women whose infants were born with PPHN and 836 women whose infants were healthy were enrolled in the study in four United States metropolitan areas between 1998 and 2003. The study showed that infants born to mothers who took SSRIs after the completion of the 20th week of gestation were 6 times more likely to have PPHN than infants who were not exposed to antidepressants during pregnancy. 14 infants with PPHN and 6 healthy control infants had been exposed to an SSRI after the 20th week of gestation. There were too few cases of PPHN with each individual SSRI to compare risks for PPHN with individual SSRIs. The study did not find an association between exposure to SSRIs during the first 20 weeks of gestation and PPHN.

Exposure to non-SSRI antidepressants did not appear to be associated with an increased risk of PPHN, although the number of infants with exposure to non-SSRI antidepressants was too small to permit a reliable risk estimate or comparison with the risk observed for SSRIs.

In weighing the risks and benefits of treatment with SSRIs and other antidepressants during pregnancy for individual patients, physicians should also note the recent publication of a prospective longitudinal study of 201 pregnant women with a history of major depression in the February 1, 2006, issue of JAMA. In this study, women who discontinued antidepressant medication during pregnancy had a higher risk of relapse of major depression during pregnancy (68%) than women who maintained antidepressant medication throughout pregnancy (26%).

SSRIs and a Combination Drug Containing an SSRI
  • Celexa (citalopram)
  • Fluvoxamine
  • Lexapro (escitalopram)
  • Paxil (paroxetine)
  • Prozac (fluoxetine)
  • Symbyax (olanzapine/fluoxetine)
  • Zoloft (sertraline)
Information for Healthcare Professionals: Olanzapine/fluoxetine (marketed as Symbyax)
 
FDA ALERT [7/2006]: Potentially Life-Threatening Serotonin Syndrome with Combined Use of SSRIs or SNRIs and Triptan Medications
There is the potential for life-threatening serotonin syndrome (a syndrome of changes in mental status, autonomic instability, neuromuscular abnormalities, and gastrointestinal symptoms) in patients taking 5-hydroxytryptamine receptor agonists (triptans) and selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/norepinephrine reuptake inhibitors (SNRIs) concomitantly (see drug names at the bottom of this sheet). This information is based on reports of serotonin syndrome occurring in patients treated with triptans and SSRIs/SNRIs, and the biological plausibility of such a reaction in persons receiving two serotonergic medications. The FDA recommends that patients treated concomitantly with a triptan and an SSRI/SNRI be informed of the possibility of serotonin syndrome (which may be more likely to occur when starting or increasing the dose of an SSRI, SNRI, or triptan) and be carefully followed.
This information reflects FDA’s current analysis of data available to FDA concerning these drugs. FDA intends to update this sheet when additional information or analyses become available.
To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program either online, by regular mail or by fax, using the contact information at the bottom of this page.
Considerations
  • Weigh the potential risk of concomitant SSRI/SNRI and triptan use with the benefit expected from using each drug, prior to prescribing these drugs together.
  • When prescribing an SSRI or a triptan, physicians should discuss the possibility of serotonin syndrome with patients if an SSRI and a triptan will be used concomitantly. Healthcare providers should keep in mind that triptans are often used intermittently, and that the SSRI, SNRI, or triptan may be prescribed by a different healthcare provider.
  • Healthcare providers should be alert to the highly variable signs and symptoms of serotonin syndrome. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
  • If concomitant treatment with an SSRI or SNRI and triptan is clinically warranted, the patient should be carefully observed, particularly during treatment initiation and dose increases.
Data Summary

The FDA has reviewed 27 reports of serotonin syndrome reported in association with concomitant SSRI or SNRI and triptan use. Two reports described life-threatening events and 13 reports stated that the patients required hospitalization. Some of the cases occurred in patients who had previously used concomitant SSRIs or SNRIs and triptans without experiencing serotonin syndrome. The reported signs and symptoms of serotonin syndrome were highly variable and included respiratory failure, coma, mania, hallucinations, confusion, dizziness, hyperthermia, hypertension, sweating, trembling, weakness, and ataxia. In 8 cases, recent dose increases or addition of another serotonergic drug to an SSRI/triptan or SNRI/triptan combination were temporally related to symptom onset. The median time to onset subsequent to the addition of another serotonergic drug or dose increase of a serotonergic drug was 1 day, with a range of 10 minutes to 6 days.

Serotonin syndrome following concomitant SSRI or SNRI and triptan use is biologically plausible. SSRIs, SNRIs, and triptans independently increase serotonin levels. Therefore, it is expected that concomitant use of SSRIs or SNRIs and triptans would result in higher serotonin levels than the serotonin levels observed with the use of SSRIs, SNRIs, or triptans alone, potentially leading to serotonin syndrome.
SRIs and a Combination
Drug Containing an SSRI		SNRIsTriptans
  • Celexa (citalopram)
  • Fluvoxamine
  • Lexapro (escitalopram)
  • Paxil (paroxetine)
  • Prozac (fluoxetine)
  • Symbyax (olanzapine/fluoxetine)
  • Zoloft (sertraline)
  • Cymbalta (duloxetine)
  • Effexor (venlafaxine)
  • Amerge (naratriptan)
  • Axert (almotriptan)
  • Frova (frovatriptan)
  • Imitrex (sumatriptan)
  • Maxalt and Maxalt-MLT (rizatriptan)
  • Relpax (eletriptan
  • Zomig and Zomig ZMT(zolmitriptan)

9/2006: The issue described in the 4/11/2005 alert has been addressed in product labeling.
FDA Alert [4/11/2005]: Increased Mortality in Patients with Dementia-Related Psychosis
FDA has determined that patients with dementia-related psychosis treated with atypical (second generation) antipsychotic medications are at an increased risk of death compared to placebo. Based on currently available data, FDA has requested that the package insert for Symbyax be revised to include a black box warning describing this risk and noting that this drug is not approved for this indication.
This information reflects FDA’s current analysis of all available data concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
To report any unexpected adverse or serious events associated with the use of Symbyax, please contact the FDA MedWatch program either online, by regular mail or by fax, using the contact information at the bottom of this page.
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