ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Friendly User's Guide for the Timing of Nutritional Supplements

The Health Benefits of Manuka Honey

Increase Your Magnesium Intake

Vitamin D supplementation could ease IBS symptoms

Top Tips to Boost Your Immunity

11 Amazing Health Benefits of Using Baking Soda

Nicotinamide riboside shows promise for treatment of Alzheimer’s disease

Exercise, calcium, vitamin D, and other factors linked with fewer injurious falls

Vitamin D3 Is a Powerhouse for Your Heart

Curcumin Supplementation May Impart Long-Term Cognitive Benefits

 
Print Page
Email Article

Physicians Conducting Study to Analyze the Outcomes Of Pregnancy in Women Treated with Neoral® for Rheumatoid Arthritis

  [ Not Yet Rated ]   [ Discuss This Article ]
By News Release • www.ProHealth.com • March 31, 2000


SUMMARY: Previously collected data suggests there is not a pattern of malformations in the newborn of mothers maintained on Neoral during pregnancy. In addition to retrospective reports, the new Neoral Registry will involve enrollment of patients before the outcome of the pregnancy is known, thereby collecting data prospectively. Patients can self-enroll or enroll through their healthcare provider

PHILADELPHIA, March 31 /PRNewswire/ -- In a collaboration with industry, physicians at Thomas Jefferson University Hospital, Philadelphia, are evaluating the outcomes of pregnancy in women with rheumatoid arthritis and psoriasis who have been treated with Neoral® (cyclosporine, USP). A three-year grant from Novartis was awarded to Jefferson to develop this U.S. national registry for pregnant women with rheumatoid arthritis or psoriasis who are treated with Neoral.

The Food and Drug Administration approved Neoral for use in the United States in May 1997 for severe active rheumatoid arthritis (RA) inadequately controlled by standard immunosuppressive therapy. In June 1997, Neoral was also approved for the treatment of severe recalcitrant plaque psoriasis (PSO) for patients who were intolerant or unresponsive to at least one other systemic therapy. The FDA asked Novartis to establish a registry for pregnant PSO and RA patients exposed to Neoral during pregnancy and to collect data on their outcomes.

Since 1991 the National Transplantation Pregnancy Registry (NTPR) at Thomas Jefferson University has followed the outcomes of pregnancies in transplant patients as well as those pregnancies fathered by male transplant recipients. Almost all of these recipients are on immunosuppressive anti-rejection therapy, which can include Neoral.

"We were contacted by Novartis because of our extensive experience with tracking immunosuppressant use in pregnancy in the transplant population," said Vincent T. Armenti, M.D., Ph.D., Professor of Surgery at Jefferson Medical College, Thomas Jefferson University, and principal investigator for both the Neoral Registry and the NTPR. Having developed the NTPR and thus having the experience of tracking pregnancy outcomes with exposure to immunosuppressants, Novartis felt that a registry developed at Jefferson could provide the information requested by the FDA.

Since its establishment in 1991, the NTPR has followed more than 2,000 pregnancy outcomes in transplant recipients. The NTPR currently uses a retrospective data collection method.
"From analyses of data collected by the NTPR, we have not found a specific pattern of malformations in the newborn of mothers maintained on Neoral during pregnancy," said Dr. Armenti. In addition to retrospective reports, the new Neoral Registry will involve enrollment of patients before the outcome of the pregnancy is known, thereby collecting data prospectively. Patients can self-enroll or enroll through their healthcare provider
.
"We will be very much dependent on the cooperation of physicians and patients nationwide, said Dr. Armenti. We are interested in all cases as the numbers may be limited and it will be very important to track as many cases as possible." As new drugs are released and there is a need to monitor their safety during pregnancy, pregnancy registries with university and industry collaboration will be an important resource for healthcare providers.

In addition to Dr. Armenti, a team of collaborating physicians for the Neoral Registry includes: Ronald J. Wapner, M.D., Professor of Obstetrics and Gynecology and Director, of the Division of Maternal-Fetal Medicine; Amy Levine, M.D., Assistant Professor of Obstetrics and Gynecology (Maternal-Fetal Medicine); J. Bruce Smith, M.D., Professor of Medicine (Rheumatology); Magaly Del Monaco, D.O., Assistant Professor of Dermatology and Cutaneous Biology (Dermatology); and Michael J. Moritz, M.D., Associate Professor of Surgery and Director of the Division of Transplantation (Surgery).

Source: Thomas Jefferson



Post a Comment

Featured Products From the ProHealth Store
FibroSleep™ Optimized Curcumin Longvida® Ultra EPA  - Fish Oil


Article Comments



Be the first to comment on this article!

Post a Comment


 
Optimized Curcumin Longvida with Omega-3

Featured Products

Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid

Natural Remedies

Probiotic Mint Promotes Healthy Gums & Teeth, Freshens Breath and Whitens Teeth Probiotic Mint Promotes Healthy Gums & Teeth, Freshens Breath and Whitens Teeth
Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance
The Brain Boosting and Fatigue Fighting B-12 The Brain Boosting and Fatigue Fighting B-12
Fighting Fatigue with Ground-breaking French Oak Wood Extract Fighting Fatigue with Ground-breaking French Oak Wood Extract
Priming Your Immune System for Cold & Flu Season Priming Your Immune System for Cold & Flu Season

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2018 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map