ProHealth fibromyalgia 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

The Cannabis Science Fibromyalgia Pain Patch: Fact or Fiction?

Brain Fog

Could Fibromyalgia Be A Low-Endorphin Disease?

Top 10 Benefits of Laughter for Fibromyalgia

The Difference Between Fibromyalgia Tender Points and Myofascial Trigger Points

SURVEY: Cognitive Impairment II

Chronic Christmas: Surviving the Holidays with a Chronic Illness

Top 3 Nutrients to Detox the Liver and Soothe Digestion

Beginning Again: Living with the Ups and Downs of Life with Chronic Illness

Are persons with fibromyalgia or other musculoskeletal pain more likely to report hearing loss? A HU...

 
Print Page
Email Article

Cymbalta and Pregnancy: A Safety Report

  [ Not Yet Rated ]   [ Discuss This Article ]
www.ProHealth.com • March 8, 2013


Note: You may read the full text of this article free HERE.

Duloxetine and pregnancy outcomes: safety surveillance findings.
– Source: International Journal of Medical Sciences, February 28, 2013

By:  S.L. Hoog, et al.

Abstract:

Background: Duloxetine hydrochloride is approved for the treatment or management of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, chronic musculoskeletal pain, and fibromyalgia in the United States. These conditions affect millions of women, including those of childbearing potential.

In pregnancy, pharmacological treatment is justified only if the potential benefits outweigh potential risks to mother and fetus, neonate or infant. There are no adequate and well-controlled studies in pregnant women treated with duloxetine. Post-marketing surveillance is an important tool for the assessment of drug safety in pregnancy in a naturalistic setting.

Objective: Using safety surveillance and spontaneous adverse events reporting databases, to provide pregnancy outcomes statistics as they relate to duloxetine exposure.

Study design and Setting: This was an analysis of pregnancy outcome data captured in Lilly Safety System (LSS) (a safety database for the collection, storage, and reporting of adverse events involving Lilly Products), through October 31 2011 and the FDA Adverse Events Reporting System (AERS) database through September 30 2011. Both databases provided spontaneous reporting data from the time of first duloxetine marketing authorization in 2004; in addition, the LSS Database includes serious adverse event and pregnancy data from clinical trials since the creation of the database in 1983.

Patients: Patients who had received duloxetine during pregnancy and reported pregnancy outcomes.

Main outcome measures: Normal and abnormal pregnancy outcomes. Abnormal outcomes comprised spontaneous abortion, premature/post-term birth, congenital anomaly, perinatal/post-perinatal complication, still birth, and ectopic pregnancy. Descriptive statistics are provided for LSS data. A disproportionality analysis was performed using the Empirical Bayes Geometric Mean (EBGM) for the AERS data. The lower bound of the 90% confidence interval of EBGM (EB05) ?1 was used as the threshold to determine disproportionality.

Results: In the LSS analysis, 400 pregnancy cases with a known pregnancy outcome were identified. Of the 233 prospectively reported cases, 170 (73%) were spontaneous reports; the remainder were reported from clinical trials (58 [25%]) or post-marketing studies (5 [2%]). In most of these cases (74%), patients received duloxetine for the treatment of depression.

  • Pregnancy outcomes were normal in 143 cases, and abnormal in 90 cases.

  • Abnormal pregnancy outcomes were mainly spontaneous abortions (n=41), post/perinatal conditions (n=25) or premature births (n=19).

  • In patients with abnormal pregnancy outcomes, relevant concomitant medication use and relevant medical history were more frequently reported, compared to those with normal pregnancy outcomes (p<0.05).

  • For the AERS database analysis, EB05 was less than one for all clusters of abnormal pregnancy outcomes;

  • there was no disproportionality of reporting adverse pregnancy outcomes for patients treated with duloxetine versus all other drugs or selected antidepressants.

Conclusion: While limitations of these data are recognized, the information available to date from these two data sources suggest that the frequency of abnormal outcomes reported in duloxetine pregnancy cases is generally consistent with the historic control rates in the general population.


Source: International Journal of Medical Sciences, February 28, 2013. By:  S.L. Hoog, Y. Cheng, J. Elpers, S.A. Dowsett. Eli Lilly and Company, Indianapolis, IN 46285, USA.





Post a Comment

Featured Products From the ProHealth Store
Fibro Freedom™ Guaifenesin FA™ Energy NADH™ 12.5mg


Article Comments



Be the first to comment on this article!

Post a Comment


 
Natural Pain Relief Supplements

Featured Products

Guaifenesin FA™ Guaifenesin FA™
Helps the Body Eliminate Excess Calcium and Phosphates
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Fibro Freedom™ Fibro Freedom™
Soothes, Strengthens & Revitalizes
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 Your Brain Needs for Detox & Sharpness

Natural Remedies

Top 3 Nutrients to Detox the Liver and Soothe Digestion Top 3 Nutrients to Detox the Liver and Soothe Digestion
Red Yeast Rice - Natural Option for Supporting Healthy Cholesterol Red Yeast Rice - Natural Option for Supporting Healthy Cholesterol
Fatigue & Fibro Fog: Could You Have a B-12 Deficiency? Fatigue & Fibro Fog: Could You Have a B-12 Deficiency?
The Brain Boosting and Fatigue Fighting B-12 The Brain Boosting and Fatigue Fighting B-12
Aching Muscles? Top 10 Nutrients to Take Back Your Life Aching Muscles? Top 10 Nutrients to Take Back Your Life

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

© 2016 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map