Activate Now
 
ProHealth me-cfs 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

May 12th is International ME/CFS, Lyme, and FM Awareness Day!

Are You ‘Activated’? Mast Cell Activation Syndrome and ME/CFS/FM

A Path Of Emotional Growth

What Are You Looking Forward To?

ME/CFS in Children

3 Ways to Support Your Spouse When You're Chronically Ill

Low Dose Naltrexone - An Effective Treatment for ME/CFS?

You Can Change Your Mind

An Eye on "The Mitochondria Man": Robert Naviaux and Chronic Fatigue Syndrome (ME/CFS)

8 Hacks to Slash Medication Costs

 
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
MitoQ® B-12 Extreme™ Hydroxocobalamin Extreme™

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products


Article Comments



Be the first to comment on this article!

Post a Comment


 
20 Helpful Tips for Cleaning and Organizing When You're Chronically Ill

Featured Products

B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 Your Brain Needs for Detox & Sharpness
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function

Natural Remedies

The Big Blue Fish that Helps Chase the Blues Away The Big Blue Fish that Helps Chase the Blues Away
Natural Relief for Soreness, Pain and Swelling – Putting Out the Fire
Coconut Oil - Healthy Gifts from the 'Tree of Life' Coconut Oil - Healthy Gifts from the 'Tree of Life'
Olea25 Olive Hydroxytyrosol Hits Astonishing 68,000+ ORAC Antioxidant Value Olea25 Olive Hydroxytyrosol Hits Astonishing 68,000+ ORAC Antioxidant Value
Why Berries Offer a Rainbow of Health Benefits Why Berries Offer a Rainbow of Health Benefits

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

· Become a Wholesaler

· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE AND SAVE 15% NOW*
Be the first to know about new products, special discounts and the latest health news. *New subscribers only

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

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