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

Monthly Archives: February 2013

Sequester may or may not slow down approvals of generic drugs

Posted in Generic Drugs, Politics

Could go either way.  Probably won’t have any effect on whether or not injured consumers can sue if they took generics. Hamburg said FDA has collected $125 million in GDUFA fees for 2013 so far. However, she noted, the budget situation and sequestration have “significant implications” for using generic user fees and budget dollars. Budget… Continue Reading

Our New Pharmacovigilance Specialist

Posted in DangerousDrugs.US

I’d like to introduce you to Jared Fink, who works for my firm as a Pharmacovigilance Specialist. What is a Pharmacovigilance Specialist, you ask? Well, every pharmaceutical company in the world has a team of folks who scour medical literature, the Internet, and other sources to look for signs that their drugs are causing harm…. Continue Reading

More on the Alabama generics ruling

Posted in Uncategorized

Behind a paywall, but still relevant: Business groups are urging Alabama’s highest court to reconsider its recent ruling that name-brand drug makers can be held liable for injuries caused by the generic versions of their products.   Source: Generic-Drugs Court Decision Irks Businesses – WSJ.com

Brand-name drug makers are not happy about Alabama Supreme Court ruling

Posted in Brand Name Liability, Legal Issues

Back in January the Alabama Supreme Court issued a ruling that enabled individuals who took generic drugs to sue the brand-name manufacturer.  Not surprisingly, the brand-name companies are not happy: BIRMINGHAM, Alabama — Brand name makers of a drug used to treat acid reflux and other digestive problems today asked the Alabama Supreme Court to… Continue Reading

1997 – Paxil Causes Neonatal Abstinence Syndrome

Posted in Paxil Birth Defects, SSRI Birth Defects

Published in a 1997 edition of The British Journal of Psychiatry by the medical researchers M.L. Dahl et al., a letter to the editor titled “Paroxetine withdrawal syndrome in a neonate” aimed to describe and characterize neonatal withdrawal from Paxil® addiction through exposure to the drug during gestation. This letter describes a case report, a… Continue Reading

Paxil Linked to Birth Defects

Posted in Paxil Birth Defects, SSRI Birth Defects

In 2007, medical researchers J. Alexander Cole et al. published a report on the increased likelihood of congenital malformations in infants whose mothers used Paxil® (paroxetine) during pregnancy and found some startling results. This study, titled “Paroxetine in the first trimester and the prevalence of congenital malformations,” published in the journal Pharmacoepidemiology and Drug Safety,… Continue Reading

Neonatal Withdrawal Syndrome caused by Prozac SSRI

Posted in Prozac Birth Defects, SSRI Birth Defects

Published in a 2000 edition of the Journal of Perinatology, Dr. Chandrakala Mohan and Dr. John Moore present a case review of an infant suffering from fluoxetine (Prozac®) intoxication at birth.  Prozac® is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI) that regulates levels of serotonin in the brain, since serotonin is… Continue Reading

Paxil, Prozac, Celexa Linked to Neonatal Abstinence Syndrome

Posted in Celexa Birth Defects, Paxil Birth Defects, Prozac Birth Defects, SSRI Birth Defects

In 2001, a research paper from a team based in Norway, headed by H. Nordeng, presented the results of a study titled “Neonatal withdrawal syndrome after in utero exposure to selective serotonin reuptake inhibitors [(SSRIs)],” the main conclusion of which was that “Neonatal withdrawal syndrome can occur after third trimester in utero SSRI exposure.”[1] This… Continue Reading

Prozac can cause low birth weight

Posted in Prozac Birth Defects, SSRI Birth Defects

In 2003, a study by Dr. Victoria Hendrick et al. titled “Birth outcomes after prenatal exposure to antidepressant medication” was published in The American Journal of Obstetrics and Gynecology, aiming to evaluate the risk for congenital malformations in infants whose mothers used antidepressant medication during pregnancy. Using many different parameters and studying different antidepressant drugs… Continue Reading

Paxil Tied to Birth Defects

Posted in Paxil Birth Defects

In 2006, a research study by Bérard et al., a Canadian research team, titled “First Trimester Exposure to Paroxetine and Risk of Cardiac Malformations in Infants: The Importance of Dosage” was published in Birth Defects Research (Part B) that made several important conclusions about the safety of Paxil® use during pregnancy. In 1,403 infant-mother pairs… Continue Reading

Will consumers once again be able to sue generic drug manufacturers?

Posted in Generic Drugs, Preemption

Longtime readers of this (or any drug-related blog) know that the U.S. Supreme Court ruled that manufacturers of generic drugs cannot be sued for failure-to-warn claims.  The ruling created a legal injustice for those injured by generic drugs. While every plaintiff’s lawyer has secretly hoped that Congress would fix the law, we’re all savvy enough… Continue Reading

2005 – Research Shows Paxil, Prozac Triple Risk for Neonatal Behavioral Syndrome

Posted in Misc. Drugs, Paxil Birth Defects, Prozac Birth Defects, Zoloft Birth Defects

Published in a 2005 edition of the Journal of the American Medical Association, a study by Dr. Eydie L. Moses-Kolko et al., titled “Neonatal Signs After Late In Utero Exposure to Serotonin Reuptake Inhibitors,” reviews the danger posed to infants whose mothers used serotonin reuptake inhibitors (SRIs), a new type of antidepressant and anti-anxiety medication…. Continue Reading

2006 – Children Suffer SSRI Withdrawal Symptoms After Birth

Posted in Paxil Birth Defects, SSRI Birth Defects

In 2006, a study published in the Archives of Pediatric Adolescent Medicine by Dr. Rachel Levinston-Castiel et al aimed to evaluate whether or not children exposed to selective serotonin-reuptake inhibitors (SSRI) antidepressants before birth would exhibit symptoms of neonatal abstinence syndrome, a condition had by infants that became addicted to drugs or medications used by… Continue Reading

Paxil, Prozac, and Elevated Risk for Heart Defects

Posted in Paxil Birth Defects, Prozac Birth Defects

Because depression is so common during pregnancy, “ranging between 7% and 19% in developed countries,”[1] a great deal of research is currently being published with regard to the safety of using antidepressant medications during pregnancy.  Recently, a number of birth defects have been associated with maternal use of SSRIs (selective serotonin reuptake inhibitors) during pregnancy,… Continue Reading

Celexa During Pregnancy and Birth Defects

Posted in Celexa Birth Defects, SSRI Birth Defects

Celexa® (citalopram) is a selective serotonin reuptake inhibitor (SSRI), one in a new class of antidepressant drugs.  These medications aim to influence (and raise) levels of a chemical called serotonin in the brain.  Serotonin is a neurotransmitter, a molecule that relays “messages” between brain cells, or neurons.  When a neuron fires, neurotransmitters like serotonin are… Continue Reading

Zoloft, Paxil, other SSRIs May Cause Birth Defects

Posted in Misc. Drugs, Paxil Birth Defects, Prozac Birth Defects, Zoloft Birth Defects

A 2006 study from Denmark, published in the medical journal Epidemiology, has evaluated the risk for birth defects and other neonatal complications that results from maternal use of SSRI drugs during pregnancy.  “SSRI” stands for selective serotonin reuptake inhibitor and represents a new class of antidepressant drugs that change levels of serotonin in the brain. … Continue Reading

Persistent Pulmonary Hypertension of the Newborn (PPHN) Linked to Maternal Use of SSRI Drugs during Pregnancy

Posted in SSRI Birth Defects

Overview of Persistent Pulmonary Hypertension of the Newborn Persistent pulmonary hypertension of the newborn (PPHN) is a congenital heart defect (present at birth) characterized by the failure of the circulatory system of the fetus to transition properly for circulation outside the womb.  Before a child is born, it gains oxygen-laden blood directly from its mother… Continue Reading

Patent Foramen Ovale Birth Defect Linked to Maternal Use of SSRI Drugs During Pregnancy

Posted in Paxil Birth Defects, SSRI Birth Defects

Patent foramen ovale (PFO) is a birth defect characterized by a minor malformation in the heart, where a small hole “between the right and left atria (upper chambers) of the heart that fails to close naturally soon after a baby is born.”[1]  Patent foramen ovale is a type of atrial septal defect, a class of conditions… Continue Reading

Clubfoot Birth Defect Linked to Maternal Use of SSRIs

Posted in Paxil Birth Defects, SSRI Birth Defects

Clubfoot is a congenital defect (present at birth) characterized by the malformation of the feet, and “is the most common congenital disorder of the legs.”[1]  MedlinePlus, a prominent online medical encyclopedia curated by the United States National Library of Medicine and the National Institutes of Health, states that clubfoot “can range from mild and flexible to severe… Continue Reading

Spina Bifida Linked to SSRI Use

Posted in Misc. Drugs, Paxil Birth Defects, Prozac Birth Defects, Zoloft Birth Defects

Spina Bifida (“myelomeningocele” being the most common form) is a birth defect in the larger class of “neural tube defects,” characterized by the malformation or underdevelopment of the neural tube in a developing infant before birth.  In spina bifida, “the backbone and spinal canal do not close before birth”[1] as they normally would. PubMed Health,… Continue Reading