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Here is a general outline of the REMS FDA has mandated so far, as well as a listing of drugs where it has been announced that REMS are being developed or drugs with safety issues that could invoke a REMS.
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Drug & Sponsor
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Reason for REMS
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Elements of REMS
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Timetable for Assessments
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Post-marketing Requirements
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Actemra (tocilizumab)
Roche
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Drug associated with risks of serious infections, gastrointestinal perforations, changes in liver function, decreases in peripheral neutrophil counts, decreases in platelet counts, elevations in lipid parameters in peripheral blood, demyelinating disorders, and malignancies
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MedGuide, communication plan and timetable for assessments
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Conduct non-clinical animal studies
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ActoPlus Met XR (pioglitazone hydrochloride and metformin hydrochloride)
Takeda
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Drug associated with increased risk of fracture in women
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MedGuide and timetable for assessments
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Advair Diskus, Advair HFA (fluticasone/
salmeterol)
GlaxoSmithKline
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New safety information from three controlled clinical trials identified an increased risk of pneumonia in COPD patients who take Advair Diskus
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MedGuide and timetable for submission of assessments
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1st: Oct. 2009
2nd: April 2011
3rd: April 2015
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Ampyra (dalfampridine)
Acorda
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Drug associated with an increased risk of seizure
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MedGuide, communication plan, elements to assure safe use, implementation system, and timetable for assessments
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Aplenzin (bupropion)
Biovail Laboratories
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Antidepressants are associated with an increased risk of suicidality in children, adolescents and young adults in short-term studies of major depressive disorder and other psychiatric disorders
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MedGuide and timetable for submission of assessments
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1st: Nov. 2009
2nd: May 2011
3rd: May 2015
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Anti-epileptic class: Clonazepam (Roche's Klonopin and Klonopin ODT), Clorazepate (Ovation's Tranxene and generics), Ethosuximide (Pfizer's Zarontin and generics), Ethotoin (Ovation's Peganone), Lacosamide (Schwarz's Vimpat), Levetiracetam (UCB's Keppra and Keppra XR and generics), Lamotrigine (GlaxoSmithKline's Lamictal and generics), Levofloxacin (J&J's Levaquin), Pregabalin (Pfizer's Lyrica), Primidone (Valeant's Mysoline and generics), Norfloxacin (Merck's Noroxin), Rufinamide (Eisai's Banzel), Topiramate (J&J's Topamax), Zonisamide (Eisai's Zonegran and generics)
Not yet finalized:
Carbamazepine (Shire's Carbatrol, Validus' Equetro, Novartis' Tegretol and Tegretol XR, and generics), Divalproex sodium (Abbott's Depakote franchise and generics), Felbamate (Meda's Felbatol), Gabapentin (Pfizer's Neurontin and generics), Mephenytoin (formerly marketed as Novartis' Mesantoin), Methsuximide (Pfizer's Celontin), Oxcarbazepine (Novartis' Trileptal and generics), Phenytoin (Pfizer's Dilantin and generics), Tiagabine (Cephalon's Gabitril), Trimethadione (Abbott's Tridione), Valproic Acid (Abbott's Depakene, Banner's Stavzor ER)
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Drugs associated with risk of suicidality
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MedGuide and timetable for submission of assessments
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18 months, 3 years and 7 years
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Avelox (moxifloxacin hydrochloride)
Bayer
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Fluoroquinolone antibiotic carries increased risk of tendonitis and tendon rupture
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MedGuide, communication plan, elements of safe use, implementation system, timetable for submission of assessments
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Banzel (rufinamide)
Eisai
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Drug associated with increased the risk of suicidal thoughts or behavior
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MedGuide and timetable for assessments
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Conduct non-clinical trial
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Byetta (exenatide)
Amylin/Lilly
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Drug associated with risk of pancreatitis
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MedGuide, communication plan and timetable for assessments
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Botulinum toxin class:
Allergan's Botox (botulinum toxin type B), Ipsen/Medicis' Dysport (abobotulinum toxin A), Solstice Neurosciences' Myobloc (botulinum toxin type B)
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Drugs carry risk of adverse events when the effects of the toxin spread beyond the site where it was injected; REMS also warns the products are not interchangeable
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MedGuide, communication plan, survey, timetable for submission of assessments
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Cambia (diclofenac)
Kowa Pharma
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Drug associated with increased risk of cardiovascular events and gastrointestinal toxicity
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MedGuide, communication plan, elements to assure safe use, implementation system, and timetable for assessments
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December 2010, June 2012, June 2016
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Cimzia (certolizumab pegol)
UCB
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To ensure the benefits of the drug outweigh the risks of opportunistic infections, development of lymphoma, other malignancies and demyelinating and autoimmune disorders in Crohn's patients
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MedGuide and timetable for submission of assessments
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1st: Nov. 2009
2nd: May 2011
3rd: May 2015
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Conduct four clinical trials and one observational study
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Cipro (ciprofloxacin)
Bayer
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Fluoroquinolone antibiotic carries increased risk of tendonitis and tendon rupture
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MedGuide, communication plan, elements of safe use, implementation system, timetable for submission of assessments
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Copegus (ribavirin)
Roche
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Risks include teratogenicity and anemia
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Medication guide
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18 months, 3 years and 7 years
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Creon (pancrelipase)
Solvay
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Porcine-derived pancreatic enzyme products carry risk of fibrosing colonopathy with high doses, and the theoretical risk of transmission of viral disease to patients
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MedGuide and timetable for submission of assessments
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Two observational studies; clinical study; seven reports on risk, prevention, quality and surveillance
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Dulera (mometasone furoate/formoterol fumarate)
Schering (Merck)
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To inform health care providers and patients of the increased risk of asthma-related death and serious outcomes with the long-acting heta2-adrenergic agonists (LABA) class, as well as other serious risks, and inform them about appropriate use
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Medication guide and communication plan consisting of a "Dear Health Care Provider" letter and website
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Annually
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Effient (prasugrel)
Lilly/Daiichi Sankyo
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Drug associated with serious risk of major bleeding and a signal of a serious risk of increased incidence of malignancies
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MedGuide, communication plan and timetable for assessments
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Jan. 31, 2011, Jan. 31, 2012, and Jan. 31, 2016
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Conduct six trials (two mandatory), including a potential way to control excess bleeding
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Embeda (abuse-resistant morphine)
King Pharmaceuticals
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Drug poses a high abuse risk and places undue burden on the health care system
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MedGuide, communication plan, prescriber training program, and patient monitoring and prescription tracking
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Enbrel (etanercept)
Amgen
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New safety information shows that serious infections, including tuberculosis, have occurred in patients taking Enbrel
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MedGuide and timetable for submission of assessments
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1st: Nov. 2009
2nd: May 2011
3rd: May 2015
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Entereg (alvimopan)
Adolor
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Drug associated with the risk of myocardial infarction
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Communication plan, elements to ensure safe use, an implementation system, a timetable for assessments and assessments of REMS
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Conduct one clinical trial
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Erythropoiesis-stimulating agents class
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Drugs accelerates tumor growth and results in earlier deaths in some cancer patients
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MedGuide, health care provider education, timetable for assessments
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Exalgo (Hydromorphone)
Alza
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Drug has potential for abuse, misuse, overdose and addiction
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MedGuide, elements to assure safe use, implementation system (including dear doctor letter) and timetable for assessments
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Conduct two carcinogenicity studies (one in mice and one in rats)
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Exubera (inhaled insulin)
Pfizer
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New safety information from a clinical trial shows an imbalance in lung cancer cases between Exubera and controls
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MedGuide, communication plan and timetable for assessments
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18 months, 3 years and 7 years after REMS is approved
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Conduct four comparative trials, one clinical trial and a study of the PPI
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Forteo (teriparatide)
Lilly
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Drug associated with increased risk of bone cancer
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MedGuide, communication plan and timetable for assessments
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Flouroquinilones
Multiple manufacturers
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Antibiotic class associated with increased risk of tendonitis and tendon rupture
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MedGuide and timetable for assessments
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Gilenya (fingolimod)
Novartis
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Risk of bradyarrhythmia and atrioventricular block at treatment initiation, infections, macular edema, respiratory effects, hepatic effects, and fetal risk
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Medication Guide, communication plan and timetable for assessments
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A prospective, randomized, controlled trial of fingolimod 0.5 mg and 0.25 mg and an appropriate control of at least one year duration to establish safety and efficacy
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Intron A (interferon alfa-2a)
Schering-Plough
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New safety information shows cases of cerebrovascular complications due to stroke in patients with few or no expected risk factors for stroke
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MedGuide and timetable for submission of assessments
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1st: Nov. 2009
2nd: May 2011
3rd: May 2015
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Janumet (sitagliptin/ metformin)
Merck
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Drug associated with risk of pancreatitis
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MedGuide, timetable for assessments
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Januvia (sitagliptin)
Merck
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Drug associated with risk of pancreatitis
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MedGuide, timetable for assessments
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Kalbitor (ecallantide)
Dyax
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Drug associated with hypersensitivity reaction
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MedGuide, elements to assure safe use, timetable for assessments
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Kaletra (lopinavir/ritonavir)
Abbott
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Drug carries increased risk of cardiac abnormalities
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Krystexxa (pegloticase)
Savient
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To inform health care providers about anaphylaxis, infusion reactions and contraindication of use in patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency and other serious risks associated with Kystrexxa
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Medication Guide and communication plan, including Dear Healthcare Provider letters and publication of "information pieces" in certain professional journals twice yearly for first three years
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1 year, 2 years, 3 years, 5 years and 7 years
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Eight required trials, including an observational safety study in 500 patients, various preclinical studies on fetal and cardiac toxicity and trials on the IgE assay
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Letairis (ambrisentan)
Gilead
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Drug associated with hepatoxicity, teratogenicity and reduced sperm counts
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MedGuide, elements to assure safe use, implementation system and timetable for assessments
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Lotronex (alosetron)
Prometheus
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To mitigate the risk of ischemic colitis and serious complications of constipation associated with Lotronex by ensuring that the drug is used in only severely affected patients for whom benefits exceed the risks and to ensure that those risks are communicated to patients, pharmacists and prescribers
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Medication Guide, elements to assure safe use and implementation system
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After six months and then annually
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Lumizyme (alglucosidase alfa)
Genzyme
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To ensure that the known risks of anaphylaxis and severe allergic reactions, as well as the potential risks of severe cutaneous and systemic immune mediated reactions, associated with use of Lumizyme are communicated to patients and prescribers, and to mitigate the potential risk of rapid disease progression in patients less than 8 years of age for whom the safety and effectiveness of Lumizyme have not been evaluated
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Communication plan, elements to assure safe use, and implementation system for the Lumizyme ACE program
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At six months and one year from approval, and annually thereafter
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Meridia (sibutramine)
Abbott
[DRUG WITHDRAWN 10/8/10]
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To inform patients about serious risks associated with sibutramine, including cardiovascular risks
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Medication Guide
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18 months, 3 years and 7 years
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Metoclopramide Class: Alavan's Reglan and generics; Quantam Pharmics' Clopra; Baxter's injectable formulation and generics; Salix's Metozolv ODT (pending approval)
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Drugs associated risk of tardive dyskinesia
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MedGuide
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Morphine sulfate oral solution
Roxane Laboratories
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Drug is currently the only oral morphine sulfate on the market
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MedGuide and timetable for assessments
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Multaq (dronedarone)
Sanofi Aventis
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Drug associated with increased risk of death in people with severe heart failure
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MedGuide, communication plan, implementation system, and timetable for assessments
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Aug. 31, 2010 and each year thereafter until 2014, and Aug. 31, 2016
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Conduct post-marketing surveillance
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NPlate (romiplostim)
Amgen
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Drug associated with risk of bone marrow fibrosis, worsened thrombocytopenia after cessation of Nplate, thromboembolic complications, hematological malignancy or myelodysplastic syndrome, and serious complications due to medical error
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MedGuide, communication plan, elements to assure safe use, implementation system, timetable for assessments
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Conduct three registry studies and one clinical trial
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Onsolis (buccal fentanyl)
BioDelivery Sciences International
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Drug associated with risk of overdose, abuse, addiction and serious complications due to medication errors
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MedGuide, communication plan, elements to assure safe use, implementation system, and timetable for assessments
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OsmoPrep (oral sodium phosphate)
Salix Pharmaceuticals
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Drug associated with the risk of acute phosphate nephropathy
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MedGuide and timetable for assessments
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Conduct one clinical trial
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OxyContin (oxycodone controlled-release)
Purdue Pharma
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Drug associated with risk of abuse, misuse, overdose and addiction; also concern about use of doses greater than 60 mg in non-opioid tolerant patients
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MedGuide, elements to assure safe use (including prescription only by trained physicians) and timetable for assessments
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Conduct post-marketing studies, including epidemiological studies, to assess whether the changes made to the OxyContin formulation result in a decrease in misuse and abuse
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PegIntron Rebetrol Combopack (peginterferon alfa-2b/ribavirin)
Schering-Plough
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Drug associated with increased risk of cerebrovascular complications due to stroke in patients with few or no expected risk factors for stroke
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MedGuide and timetable for assessments
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1st: Nov. 2009
2nd: May 2011
3rd: May 2015
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Promacta (eltrombopag)
GSK
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Drug associated with risks of hepatoxicity, bone marrow fibrosis, worsened thrombocytopenia and hemorrhage
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MedGuide, elements to assure safe use, an implementation system, and a timetable for assessments
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Conduct prospective pregnancy registry and one clinical trial
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Propoxyphene-containing products
Darvon, Darvocet and generics
Xanodyne
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Drug associated with a high level of cardiotoxicity
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MedGuide and timetable for assessments
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Conduct five total studies - one by sponsor and others through FDA collaborations
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Qualaquin (quinine sulfate)
AR Scientific
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To curb off-label use of the antimalaria drug to treat or prevent night-time leg cramps and improve awareness of potential side effectis, including thrombocytopenia
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Medication guide and communication plan consisting of a "Dear Health Care Provider" letter
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Raptiva (efalizumab)
Genentech
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New safety information shows an increase in the risk of serious fungal and viral infections (Sponsor withdrew product from the market 6/2009)
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MedGuide and timetable for assessments
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Roferon-A (interferon alfa-2a)
Roche
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To inform patients regarding the serious risks associated with interferon alfa-2a
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Medication Guide
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18 months, 3 years and 7 years
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Sabril (vigabatrin)
Lundbeck
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Drug associated with risk of permanent vision loss and the class risk of suicidality
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MedGuide, elements to assure safe use, timetable for assessments
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Samsca (tolvaptan)
Otsuka
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Drug associated with risk of overly rapid correction of serum sodium leading to osmotic demyelination
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MedGuide, communication plan, and timetable for assessments
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A validation report
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Savella (milnacipran)
Forest
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SNRIs are associated with an increased risk of suicidality in children, adolescents and young adults in short-term studies of major depressive disorder and other psychiatric disorders
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MedGuide and timetable for assessments
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Conduct a lactation trials and pregnancy registry
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Silenor (doxepin)
Somaxon
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Hypnotic sleep medication can cause patients to fail to remember activities occurring while medicated (such as driving and eating)
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MedGuide and timetable for assessments
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Simponi (golimumab)
Centocor Ortho Biotech
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Tumor necrosis factor inhibitor carries risks of serious infections, including tuberculosis, invasive fungal infections, other opportunistic infections, malignancies, congestive heart failure and peripheral demyelinating disorders
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MedGuide, communication plan, timetable for submission of assessments
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Optimize the existing adventitious virus assay
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Soliris (eculizumab)
Alexion
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To limit the occurrence and morbidity associated with meningococcal infections, to mitigate serious outcomes for patients who develop Neisseria meningitides and other systemic infections and to impart important safety information before initiating treatment with Soliris and ensure proper use
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Medication guide and elements to assure safe use, including prescriber certification (original RiskMAP that was a "deemed REMS" did not include the certification requirement)
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Every 6 months for 1 year and then annually
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Stelara (ustekinumab)
Centocor Ortho Biotech
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Drug associated with risk of serious infections, including those caused by viruses, fungi and bacteria
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MedGuide, communication plan including dear prescriber letters, an adverse event reporting awareness campaign and other outreach efforts
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Suboxone (buprenorphine/naloxone sublingual film)
Reckitt Benckiser
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To mitigate the risks of accidental overdose, misuse and abuse and to Inform patients of the serious risks associated with Suboxone film
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Medication Guide, elements to assure safe use and implementation system
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After six months and then annually
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Sutent (sunitinib)
Pfizer
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Risk of severe hepatotoxicity resulting in death observed in clinical trials and post-marketing experiences
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Medication guide
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18 months, 3 years and 7 years
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Symbicort (budesonide/ formoterol)
AstraZeneca
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Drug associated with increased incidence of lower respiratory tract infections in patients with COPD
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MedGuide and timetable for assessments
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Tapentadol
Johnson & Johnson
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Drug associated with opioid abuse
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MedGuide and timetable for assessments
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Tasigna (nilotinib)
Novartis
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New safety information revealed cases of QT prolongation
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MedGuide, communication plan and timetable for assessments
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Testosterone gel:
Solvay's AndroGel 1% and Auxillium's Testim 1%
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Reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated
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MedGuide and timetable for submission of assessments
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Tracleer (bosentan)
Actelion
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Drug associated with potential for serious liver injury and damage to fetuses
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MedGuide, elements to assure safe use, implementation system, timetable for assessments
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Treximet (sumatriptan succinate/naproxen)
Pozen
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Non-steroidal anti-inflammatory drugs are associated with an increased risk of cardiovascular events and gastrointestinal toxicity
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MedGuide and timetable for assessments
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1st: Nov. 2009
2nd: May 2011
3rd: May 2015
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Conduct one clinical trial
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Tyzeka (telbivudine)
Novartis
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Patients have reported peripheral neuropathy, in some cases resulting in motor weakness, pain, sensory deficits and/or difficulty walking
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MedGuide and timetable for submission of assessments
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Develop a dosing cup for distribution of drug
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Venlafaxine ER
Osmotica
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Antidepressants are associated with an increased risk of suicidality in children, adolescents and young adults in short-term studies of MDD and other psychiatric disorders
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MedGuide and timetable for assessments
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1st: Nov. 2009
2nd: May 2011
3rd: May 2015
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Conduct one dose dumping study
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Vibativ (telavancin)
Theravance/Astellas
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FDA concerned about drug's use in high-risk populations
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MedGuide, letter to health care professionals
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Victoza (liraglutide)
Novo Nordisk
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Drug associated with development of thyroid C-cell tumors in pre-clinical rodent studies and potential class risk of pancreatitis
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MedGuide, communication plans and timetable for assessments
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A cardiovascular safety study, a five-year epidemiological trial to evaluate thyroid cancer and panrcreatitis risks, and a 15-year cancer registry to monitor thyroid cancer cases
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Vimpat (lacosamide)
UCB
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Drug associated with increased the risk of suicidal thoughts or behavior
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MedGuide and timetable for assessments
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Conduct non-clinical trial
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Viramune (nevirapine)
Boehringer Ingleheim
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New safety information shows that patients with moderate or sever hepatic impairment should not take Viramune due to the risk of increased nevirapine levels
|
MedGuide and timetable for assessments
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1st: Dec. 20, 2009
2nd: June 20, 2011
3rd: June 20, 2015
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Visicol (oral sodium phosphate)
Salix Pharmaceuticals
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Drug associated with the risk of acute phosphate nephropathy
|
MedGuide and timetable for assessments
|
|
Conduct one clinical trial
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Vivitrol (naltrexone)
Alkermes
|
Drug has risk of serious injection site reactions likely caused by incorrect administration of the drug
|
MedGuide and timetable for assessments
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Votrient (pazopanib)
GlaxoSmithKline
|
Drug associated with severe and fatal hepatoxicity
|
MedGuide, communication plan and timetable for assessments
|
|
|
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Wellbutrin/ Wellbutrin SR (bupropion)
GlaxoSmithKline
|
Drug associated with risk of suicidality-related events
|
MedGuide, timetable for assessments
|
|
|
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Xiaflex (collagenase clostridium histolyticum)
Auxilum
|
Drug associated with rare but serious side effect of tendon rupture if injected into the wrong site
|
MedGuide, training program and timetable for assessments
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|
Conduct three clinical studies, one non-clinical study, and one in vitro study; submit in vivo data
|
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Ziagen (abacavir)
GlaxoSmithKline
|
New safety information indicates that patients who carry the HLA-B*5701 allele are at significantly increased risk of developing abacavir hypersensitivity, which in some cases may be severe or fatal
|
MedGuide and timetable for assessments
|
1st: Jan. 2010
2nd: July 2011
3rd: July 2017
|
|
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Zipsor (diclofenac)
Xandoyne Pharma
|
Drug associated with increased risk of cardiovascular events and gastrointestinal toxicity
|
MedGuide and timetable for assessments
|
|
|
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Zonergan (zonisamide)
Eisai
|
Revision to the class REMS for anti-epileptic drugs on risk of suicidality to include language in the Zonegran Medication Guide regarding the risk of metabolic acidosis
|
MedGuide and timetable for submission of assessments
|
|
|
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Zyban (bupropion)
GlaxoSmithKline
|
Drug associated with risk of suicidality-related events
|
MedGuide, timetable for assessments
|
|
|
|
REMS To Come
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Reason for REMS
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REMS Proposal
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Acetaminophen-containing products
|
Drug associated with risk of increased liver injury
|
|
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Afrezza (insulin human rDNA)
MannKind (pending approval)
|
Drug associated with inhaled insulin class risk of lung cancer
|
|
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Avandia (rosiglitazone)
GlaxoSmithKline
|
Risk of cardiovascular events
|
FDA has requested a REMS with a restricted access program that includes provision of complete risk information to each patient with documentation that it has been understood; documentation from health care providers that patients receiving Avandia either currently take it or are unable to achieve glycemic control on other drugs and decide not to take pioglitazone for medical reasons; and physician, patient and pharmacist enrollment
|
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Belatacept
Bristol-Myers Squibb
|
Drug associated with the risk of post-transplant lymphoproliferative disorder and progressive multifocal leukoencephalopathy both seen in clinical trials
|
MedGuide, health care provider and patient education, and measures to decrease market size thereby decreasing risk
|
|
Bydureon (formerly Byetta LAR) (long-acting exenatide)
Amylin/Lilly
|
Drug associated with risk of pancreatitis; unclear whether FDA is also considering there to be a class risk of thyroid C-cell tumors as seen with Novo Nordisk's Victoza (liraglutide)
|
Existing REMS for Byetta includes MedGuide, communication plan and timetable for assessments
|
|
Certican (everolimus)
Novartis
|
Drug associated with proteinuria, delayed wound healing and serum lipid abnormalities
|
MedGuide, user surveys, communication plan, program evaluation tools, and timetable for assessments.
|
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Clolar (clofarabine)
Genzyme (pending approval for label expansion)
|
Drug associated with increased risk of infection
|
|
|
Cymbalta (duloxetine)
Pfizer
|
SNRIs are associated with an increased risk of suicidality in children, adolescents and young adults in short-term studies of major depressive disorder and other psychiatric disorders
|
|
|
Daxas (roflumilast)
Forest
|
To establish safety in a narrow patient population for the chronic obstructive pulmonary disease drug, due to modest benefit and potential suicidality risk
|
|
|
Egrifta (tesamorelin)
Theratechnologies
|
Concerns about increases in insulin-like growth factor 1, changes in glucose metabolism and immunogenicity seen in clinical trials
|
Efforts to educate HIV prescribers and patients about safe and effective use of Egrifta and to encourage appropriate prescribing for the indicated patient population; proposed long-term observational safety study
|
|
Krystexxa (pegloticase, formerly Puricase)
Savient (pending approval)
|
Drug increases the risk of cardiovascular events
|
MedGuide, elements to assure safe use, certification program, and performance-linked access program for prescribers, infusion sites and patients
|
|
Liraglutide
NovoNordisk (pending approval)
|
Drug associated with pre-clinical thyroid cancer signal in rodents
|
|
|
Long acting beta-2 adrenergic agonists class
|
Drugs associated with increased risk of severe asthma symptoms, hospitalization and death
|
MedGuide, education plans for health care professionals, new labeling changes, more safety studies, and timetable for assessments
|
|
Opioid Class: Ortho McNeil/Janssen's Duragesic (fentayl patch); Purdue'sPalladone (hydromorphone), MS Contin (morphine sulfate) and OxyContin (oxycodone); Roxane's Dolophine (methadone); King's Avinza (morphine); Actavis' Kadian (morphine); Xanodyne's Oramorph (morphine sulfate); Endo's Opana (oxymorphone); corresponding generics
|
The potent opioid products pose a high abuse risk and place undue burden on the health care system
|
|
|
Potiga (ezogabine)
Valeant
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Risk of urinary retention and other potential adverse effects, including cardiac effects and QT prolongation, neuropsychiatric effects such as psychosis and hallucinations, and liver function disorders
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Medication guide, printed information packet for patients, caregivers and health care providers and enhanced pharmacovigilence, as well as a dedicated website and toll-free number for health care providers on urinary retention issues and an observational study
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Prolia (denosumab)
Amgen (pending approval)
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Drug associated with increased malignancies
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MedGuide, communication plan, timetable for assessments
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Phenergen (promethazine)
Wyeth
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The Supreme Court ruled that Wyeth could have added a stronger warning to labeling for the anti-nausea drug after accumulating data about the risk of I.V.-push administration
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Qnexa (phentermine/topiramate)
Vivus
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Potential to cause psychiatric-related, cognitive-related and cardiovascular adverse events and metabolic acidosis, as well as teratogenicity associated with topiramate
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Medication Guide and communication plan, plus a voluntary pregnancy registry
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Relistor (methylnaltrexone bromide)
Wyeth/Progenics
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Drug associated with potential risk of QT prolongation
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Remoxy (abuse-resistant oxycodone)
Pain Therapeutics (pending approval)
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Drug poses a high abuse risk and place undue burden on the health care system
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Similar to Embeda's REMS: MedGuide, communication plan, prescriber training program, patient monitoring and prescription tracking
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Requip XL (ropinirole)
GlaxoSmithKline
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Varying serious adverse events correlated to dose level
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Post-marketing trial to evaluate whether drug is a P-gp substrate and/or inducer for major CYP enzymes
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Sodium oxybate oral solution
Jazz
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Abuse potential (drug is the sodium salt form of gamma hydroxybutyrate) and potential CNS depressant
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Similar to the risk management program in place for Xyrem, the firm's sodium oxybate formulation for narcolepsy, which is a "deemed REMS" that has not yet been approved
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Televancin
Theravance/Astellas (pending approval)
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FDA is trying to refine its approach to high-risk populations - specifically, pregnant women, females of child-bearing age, and patients with higher risk of renal adverse events
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MedGuide, communication plan, pregnancy registry and timetable for assessments
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Xarelto (rivaroxaban)
J&J (pending approval)
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Rivaroxaban demonstrated an increased risk of major bleeding and potential hepatotoxicity during short-term clinical trials.
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Measures to mitigate risk, patient and physician education, and packaging drug in fixed-dose blister packs
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Zyban (bupropion)
GalxoSmithKline
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Drug associated with risk of potential neuropsychiatric side effects
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MedGuide
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