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Appendix XII: Pregnancy Registries

Pregnancy exposure registries have been developed to collect health information on exposure to medical products (such as drugs and vaccines) during pregnancy. These databases can be helpful resources for researchers and regulatory agencies. Pregnancy registries were identified based on several sources: a listing provided by the FDA’s Office of Women’s Health1, publications obtained through literature analysis, and web searches. A list of the pregnancy registries and large databases is provided below.

Summary A total of 45 distinct registries were identified. As shown in Figure 1, about two-thirds were sponsored by industry and about one-quarter by nonprofit organizations. Although government organizations may be involved in providing expertise and in encouraging the establishment of registries, government organizations are typically not the sponsor or manager of registries. Several registries did not list a primary sponsor or responsible organization.

Figure 1: Pregnancy Registries, by Type of Sponsoring Organization unknown, 4, 9%

nonprofit, 11, 24%

industry, 30, 67%

industry nonprofit unknown

Registries may focus on a condition, medication, or both. As shown in Figure 2, most registries determine eligibility based on either medication or condition or both, but some restrict eligibility to only those women taking a specific medication.

Figure 2: Pregnancy Registries by Eligibility Criteria

condition, 7, 15%

medication , 7, 16%

either or both, 31, 69%

condition medication either or both

1 https://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm134848.htm

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Organizations all over the world sponsor pregnancy registries. Area of origin for the sponsoring organization is shown in Figure 3. Many registries, particularly those based in Europe, accept participants from multiple countries.

Figure 3: Pregnancy Registries by Area of Origin

Unknown, 5, 11% Asia, 2, 4% USA or Canada, 18, 39%

Europe, 21, 46%

USA or Canada Europe Asia Unknown

For over one third of registries, enrollment figures were not provided. For some of the other registries identified, enrollment was very limited. Enrollment numbers are shown in Figure 4.

Figure 4: Number of Pregnancy Registries by Enrollment

20 17

15 10 10 7 4 4 5 2

0 0-100 101-500 501-1000 1001-10000 over 10000 unknown

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List of Pregnancy Registries

Registry Name Medicine(s) Medical Organization/ Enrollment Date Website Condition(s) Sponsor established The North Multiple Drugs including Aptiom Epilepsy Massachusetts 10,200 (as 1997 http://www.aedpregnancyr American AED (eslicarbazepine acetate) and General Hospital of May egistry.org/about-history/ (Antiepileptic Lyrica (pregabalin) 2016) Drug) Pregnancy Registry OTIS Multiple Drugs including Actemra Multiple Organization of 300 Mar-12 https://clinicaltrials.gov/ct2

AutoImmune (tocilizumab), Arava (), conditions Teratology /show/NCT01797224 Diseases in Aubagio (teriflunomide), Cimzia including any Information Pregnancy (), Enbrel approved Specialists Project (), Entyvio indication or (nonprofit) at the (), Humira indication University of (), Orencia currently in California, San (), Otezla (), Phase III Trials. Diego Stelara (), Xeljanz Mentioned () specifically are ; Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis; Crohn's Disease and ulcerative colitis

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Registry Name Medicine(s) Medical Organization/ Enrollment Date Website Condition(s) Sponsor established OTIS Pregnancy Multiple Drugs Asthma Organization of Unknown 2009 http://grantome.com/grant Outcomes and Teratology /NIH/R18-HS018474-01; Asthma Information https://mothertobaby.org/ Medications in Specialists ongoing-study/asthma/ Pregnancy Study (nonprofit) at the University of California, San Diego Cancer and Multiple Drugs Cancer Cooper Medical Unknown Unknown http://www.cancerandpreg Pregnancy School at Rowan nancy.com/treating-cancer-

Registry University in-pregnant-women/ Antiretroviral Multiple Drugs HIV/AIDS ViiV Healthcare; roughly 1989 https://clinicaltrials.gov/ct2 Pregnancy collaborator/spons 18787 as of (inception); /show/NCT01137981 and Registry or is INC Research, Jan 2017 2/1/1993 http://www.apregistry.com LLC and (all /forms/interim_report.pdf GlaxoSmithKline antiretrovir al drugs) National Multiple Drugs including Nulojix Transplants, Gift of Life Donor Over 2300 1991 https://www.transplantpre Transplantation () anti-rejection Program; Gift of gnancyregistry.org/about-

Pregnancy Medicines, Life Institute us/ Registry immunosuppres sants (e.g., belatacept for renal transplant)

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Registry Name Medicine(s) Medical Organization/ Enrollment Date Website Condition(s) Sponsor established National Abilify (aripiprazole), Aristada Mental Health Center for 800 Nov-08 https://clinicaltrials.gov/ct2 Pregnancy (aripiprazole lauroxil), Clozaril Disorders Women’s Mental /show/NCT01246765 and Registry for (clozapine), Fanapt (iloperidone), Health at https://womensmentalheal Atypical Geodon (ziprasidone), Invega Massachusetts th.org/clinical-and- Antipsychotics (paliperidone), Latuda General Hospital research- (lurasidone), Risperdal programs/pregnancyregistr (risperidone), Saphris (asenapine), y/atypicalantipsychotic/ Seroquel (quetiapine), Zyprexa (olanzapine) T.A.P.P. (Take Acitretin Psoriasis Teva Unknown Unknown https://www.tevagenerics. Action to Pharmaceuticals com/assets/base/acitrentin Prevent /PDFs/Acitretin_TAPP_Boo

Pregnancy) klet.pdf National Adderall (Amphetamine), ADD/ADHD Center for Unknown Unknown https://womensmentalheal Pregnancy Concerta, Daytrana, Women’s Mental th.org/clinical-and- Registry for (Methylphenidate), Desoxyn Health at research- Psychostimulant (Methamphetamine HCl), Massachusetts programs/pregnancyregistr s Dexedrine (Dextroampehetamine), General Hospital y/othermedications/ Focalin (Dextroampehetamine), Metadate CD, Methylin (methylphenidate HCL), Provigil (modafinil), Ritalin (methylphenidate HCL), Vyvanse (lisdexamfetamine Dimesylate)

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Registry Name Medicine(s) Medical Organization/ Enrollment Date Website Condition(s) Sponsor established The Vaccines Afluria Influenza Collaboration Unknown VAMPSS in http://www.aaaai.org/abo and Medications vaccine between American 2009 ut-aaaai/strategic- in Pregnancy Academy of relationships/vampss Surveillance Allergy, Asthma & System/OTIS Immunology Pregnancy (AAAAI); Studies Organization of Teratology Information Specialists Research Center at the University of California-San Diego (OTIS); Slone Epidemiology Center at Boston University (SEC); Harvard Pregnancy Research Group MPS-I Registry Aldurazyme (laronidase) MPS I, Genzyme 1500 Nov-03 https://clinicaltrials.gov/ct2

Mucopolysaccha Corporatoin /show/NCT00144794 ridosis I; Hurler's Syndrome; Scheie's Syndrome; Hurler-Scheie Syndrome

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Registry Name Medicine(s) Medical Organization/ Enrollment Date Website Condition(s) Sponsor established National Anafranil (clomipramine), Asendin Depression Center for Unknown Unknown https://womensmentalheal Pregnancy (amoxapine), Brintellix Women’s Mental th.org/clinical-and- Registry for (vortioxetine), Celexa (citalopram), Health at research- Antidepressants Cymbalta (duloxetine), Desyrel Massachusetts programs/pregnancyregistr

(trazodone), Effexor (venlafaxine), General Hospital y/antidepressants/ Effexor XR (Venlafaxine Hydrochloride), Elavil (amitriptyline), Emsam (selegiline), Fetzima (levomilnacipran), Fluoxetine (Fluoxetine Hydrochloride), Forfivo (Bupropion Hydrochloride), Lexapro (escitalopram), Ludiomil (maprotiline), Luvox (fluvoxamine), Marplan (Isocarboxazid), Nardil (phenelzine), Norpramin (desipramine), Pamelor (nortriptyline), Parnate (tranylcypromine), Paxil (paroxetine), Pristiq (desvenlafaxine), Prozac (fluoxetine), Remeron (mirtazapine), Serzone (nefazodone), Sinequan (doxepin), Surmontil (trimipramine), Tofranil (imipramine), Viibryd (Vilazodone Hydrochloride), Vivactil (protriptyline), Wellbutrin (buproprion), Wellbutrin SR (buproprion Hydrochloride), Zoloft (sertraline)

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Registry Name Medicine(s) Medical Organization/ Enrollment Date Website Condition(s) Sponsor established Benlysta Benlysta () Systemic Lupus GlaxoSmithKline; 500 Nov-11 http://pregnancyregistry.gs

Pregnancy Erythematosus collaborator/spons k.com/belimumab.html Registry (SLE) or is INC Research, LLC Bexsero Bexsero (Meningococcal Group B Meningitis GlaxoSmithKline; 50 Jan-16 http://pregnancyregistry.gs

Pregnancy Vaccine) Vaccine collaborator/spons k.com/bexsero.html Registry or is INC Research, LLC Exenatide Bydureon, Byetta (exenatide) Type 2 Diabetes AstraZeneca 7 Terminated https://clinicaltrials.gov/ct2

Pregnancy 2016 /show/NCT00579150 Registry Mycophenolate Cellcept (mycophenolate), Immunosuppres Genentech; 500 Nov-12 https://clinicaltrials.gov/ct2

Pregnancy Myfortic (mycophenolate) sive drug (renal collaborator/spons /show/NCT01733082 Registry transplant) or is INC Research, (potentially also LLC heart and liver transplants and autoimmune diseases from clinicaltrials.gov) Cymbalta Cymbalta (duloxetine HCl) Major Eli Lilly and Co.; 484 Jul-09 https://clinicaltrials.gov/ct2

Pregnancy Depressive collaborator/spons /show/NCT01074151 Registry Disorder (MDD), or is INC Research, Generalized LLC Anxiety Disorder (GAD), Diabetic Peripheral Neuropathic Pain (DPNP), Fibromyalgia Fabry Disease Fabrazyme (agalsidase beta) Fabry Disease Sanofi Genzyme 9000 Jul-01 https://clinicaltrials.gov/ct2

Registry /show/NCT00196742

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Registry Name Medicine(s) Medical Organization/ Enrollment Date Website Condition(s) Sponsor established The Gilenya Gilenya () Multiple Novartis 500 Oct-11 https://clinicaltrials.gov/ct2

Pregnancy Sclerosis (MS) Pharmaceuticals /show/NCT01285479 Exposure Registry MotHER Herceptin (Trastuzumab), Kadcyla Breast Cancer Genentech 100 Jan-09 https://clinicaltrials.gov/ct2

Pregnancy (ado-trastuzumab emtansine), /show/NCT00833963 Registry Perjeta (pertuzumab) Merck Janumet (sitagliptin phosphate Type 2 Diabetes Merck & Co., Inc. Unknown Unknown http://www.merckpregnan Pregnancy plus metformin hydrochloride), cyregistries.com/januvia.ht

Registry Januvia (sitagliptin phosphate) ml Program Merck Maxalt (rizatriptan) Migraine Merck & Co., Inc. Unknown Unknown http://www.merckpregnan Pregnancy Headaches cyregistries.com/maxalt.ht

Registry ml Program Global Juxtapid (lomitapide) Homozygous 30 Oct-14 https://clinicaltrials.gov/ct2

Lomitapide Familial /show/NCT02399839 Pregnancy Hypercholestero Aegerion Exposure lemia Pharmaceuticals, Registry Inc.

Motherisk: Lamisil Toe and Nail The Hospital for Unknown Unknown http://www.motherisk.org/ Lamisil in Fungal Sick Children Pregnancy Infections

Motherisk Meridia (sobutramine Weight Loss The Hospital for Unknown Unknown http://www.motherisk.org/ Pregnancy hydrochloride) Management Sick Children Registry Program

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Registry Name Medicine(s) Medical Organization/ Enrollment Date Website Condition(s) Sponsor established Menactra Menactra (meningococca Vaccine - Sanofi Pasteur Unknown Unknown http://www.sanofipasteurp vaccine polysaccharide diptheria toxoid) Meningococcal regnancyregistry.com/?fa=

Pregnancy Disease menactra Registry; Sanofi Pasteur Pregnancy Registry Menveo Menveo (Meningococcal Meningitis GlaxoSmithKline 100 Sep-14 http://pregnancyregistry.gs Pregnancy quadrivalent CRM-197 conjugate) Vaccine k.com/menveo.html; Registry https://clinicaltrials.gov/ct2 /show/NCT02223637 Pompe Disease Myozyme (alglucosidase alfa) Pompe Disease Sanofi Genzyme 2000 https://clinicaltrials.gov/ct2 Aug-04 Registry (GAA deficiency) /show/NCT00231400 MPS VI Clinical Naglazyme Maroteaux- BioMarin 200 July-05 https://clinicaltrials.gov/ct/ Surveillance Lamy Syndrome Pharmaceutical show/NCT00214773?order

Program (CSP) also known as =2 Polydystrophic Dwarfism or Mucopolysaccha ridosis VI Nuvigil and Nuvigil (armodafinil) and Provigil Excessive Teva 300 Jun-09 https://clinicaltrials.gov/ct2

Provigil (modafinil) sleepiness Pharmaceuticals; /show/NCT01792583 Pregnancy associated with: United BioSource Registry Obstructive Corporation Sleep Apnea, Hypopnea Syndrome, Narcolepsy, Shift Work sleep disorder

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Registry Name Medicine(s) Medical Organization/ Enrollment Date Website Condition(s) Sponsor established Amgen's Prolia (denosumab) Osteoporosis Amgen Unknown Unknown https://www.accessdata.fd Pregnancy a.gov/drugsatfda_docs/lab Surveillance el/2012/125320s0051mg.p

Program df Promacta Promacta (eltrombopag) Thrombocytope GlaxoSmithKline 1 Mar-10 https://clinicaltrials.gov/ct2

Pregnancy nia (ITP) /show/NCT01064336 Registry; GlaxoSmithKline Pregnancy Registry A Rollover Study Promacta (eltrombopag) Thrombocytope Novartis 100 Oct-13 https://www.gsk- to Provide nia (ITP) Pharmaceuticals clinicalstudyregister.com/st Continued udy/113101#ps and Treatment With https://clinicaltrials.gov/ct2 Eltrombopag /show/NCT01957176 Ribavirin Ribavirin Hepatitis C INC Research, LLC 600 Jan-04 https://clinicaltrials.gov/ct2

Pregnancy /show/NCT00114712 Registry Savella Savella Fibromyalgia INC Research, LLC 350 Nov-09 https://clinicaltrials.gov/ct2

Pregnancy /show/NCT01026077 Registry Vibativ Vibativ (telavancin) Antibacterial for Theravance 300 Nov-09 https://clinicaltrials.gov/ct2

Pregnancy skin infection Biopharma R & D, /show/NCT01130324 Registry Inc. EXPECT Xolair Xolair () Asthma Genentech 304 Oct-06 https://clinicaltrials.gov/ct2

Pregnancy /show/NCT00373061 Registry Boostrix Boostrix Diphtheria/teta GlaxoSmithKline 800 Mar-14 http://pregnancyregistry.gs pregnancy nus/pertussis k.com/boostrix.html; registry vaccine https://clinicaltrials.gov/ct2 /show/NCT02096276

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Registry Name Medicine(s) Medical Organization/ Enrollment Date Website Condition(s) Sponsor established Varilrix Varilrix Varicella vaccine GlaxoSmithKline Unknown Unknown http://pregnancyregistry.gs pregnancy k.com/Varilrix.html registry Priorix Priorix Measles, GlaxoSmithKline Unknown Unknown http://pregnancyregistry.gs pregnancy mumps, and k.com/Priorix.html registry rubella vaccine Seasonal Multiple (Fluarix, Fluarix Seasonal GlaxoSmithKline Unknown Unknown http://pregnancyregistry.gs influenza Quadrivalent, Flulaval, Flulaval influenza k.com/seasonalInfluenzaVa vaccine Quadrivalent) vaccine ccines.html pregnancy registry Biogen Multiple Tecfidera (); Multiple Biogen 750 Oct-13 https://clinicaltrials.gov/ct2

Sclerosis Pegylated human beta- Sclerosis /show/NCT01911767 Pregnancy 1a, and Dalclizumab High Yield Exposure Process Registry Vaxchora Vaxchora Cholera vaccine PaxVax Unknown Unknown https://www.paxvaxconnec Pregnancy t.com/vaxchora-pregnancy-

Registry registry EllaOne ellaOne (female emergency Female HRA Pharma Unknown Unknown http://www.hra- pregnancy contraceptive) contraceptive pregnancy- registry registry.com/en/ Flucelvax Flucelvax Influenza Seqirus Unknown Unknown http://flu.seqirus.com/fluc pregnancy vaccine elvax/pregnancy- registry registry.html

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