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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

2005 – Study finds Paxil associated with neonatal withdrawal syndrome

Posted in Paxil Birth Defects, SSRI Birth Defects

There is an ongoing debate in the medical community whether or not selective serotonin reuptake inhibitors have fetus damaging capabilities and can cause major congenital malformations for exposed offspring in utero.  There has been strong evidence that selective serotonin inhibitors have been associated with withdrawal symptoms.  A recent study published by researchers from University of La Laguna, in Tenerife, Spain, titled “Selective Serotonin Reuptake Inhibitors in Pregnant Women and Neonatal Withdrawal Syndrome: A Database Analysis”, investigated the use of these drugs in pregnant women might cause neonatal withdrawal syndrome.

Lead author of the above study EJ Sanz states “An association between paroxetine and neonatal convulsions was identified in December, 2001, by the data mining method routinely used to screen the WHO database of adverse drug reactions. An information component (IC) measure was used to screen for unexpected adverse reactions relative to the information in the database. We then assessed cases of neonatal convulsions and neonatal withdrawal syndrome associated with drugs included in the anatomical therapeutic chemical groups N06AB and N06AX.”

The study found that by November 2003, 93 cases of SSRI neonatal withdrawal syndrome had been reported.  These cases were thought to be adequate information to confirm a possible causal relation.  Of these cases, 9 were associated with sertraline, 7 with citalopram, 14 with fluoxetine, and 64 with paroxetine.  Sanz EJ. Concludes with “The IC-2 SD for the group became greater than 0 in the first quarter of 1991, and the IC increased to 2.68 (IC-2 SD 0.32) by the second quarter of 2003. For each individual compound, the IC-2 SD was greater than 0.”  In conclusion, this study found that SSRIs like paroxetine (Paxil) should be closely managed in the treatment of pregnant women with a psychiatric disorder.

This study and ones similar to it may be used in a Paxil neonatal withdrawal syndrome lawsuit to demonstrate to a court that the manufacturer of Paxil (GlaxoSmithKline) knew, or should have known, that Paxil is associated with neonatal withdrawal syndrome.  Due to the fact that the warning labels for Paxil have failed to include such information adequately, a number of Paxil birth defects lawsuits are currently being filed.

If you used Paxil during pregnancy and your child was born with a congenital malformation, you may be entitled to significant financial compensation for the undue injury endured by your family.  For a free, no-obligation case consultation, contact our team of Paxil® birth defects lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Call today and see how we can help!

Our SSRI Birth Defects Lawsuit Information page is a great place to start if you have any questions about SSRIs and Birth Defects.