Activate Now
 
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

The New Dual Activation Pain Relief Cream

SURVEY RESULTS: Medical Marijuana

Recipe: Mega-Golden Milk

Sweep Away Senile Cells

Vitamin D supplementation shows promise for Hashimoto's thyroiditis

A Paleolithic-type diet may help reduce future risk of diabetes and cardiovascular disease

Large whey protein breakfast may help manage type 2 diabetes

Decreased levels of vitamin D associated with reduced methylation in African American teens

Selenium — What Is it and Where Do I Get It?

Meta-analysis adds evidence to antidepressant effect for omega-3

 
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
Ultra EPA  - Fish Oil Ultra ATP+, Double Strength Energy NADH™ 12.5mg

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

Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength

Natural Remedies

Restore Youthful Cognition and Well-Being Restore Youthful Cognition and Well-Being
Reversing Neurodegeneration with a New Magnesium Compound Reversing Neurodegeneration with a New Magnesium Compound
Three-Step Strategy to Reverse Mitochondrial Aging Three-Step Strategy to Reverse Mitochondrial Aging
Stop Bacteria With Nature's Antibiotics Stop Bacteria With Nature's Antibiotics
How I Found My Long-Lost Energy How I Found My Long-Lost Energy

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