antidepressants linked to birth defects

Selective Serotonin Reuptake Inhibitors, known as SSRIs or antidepressants, treat a number of mental health conditions like depression, anxiety, borderline personality disorder, and other mood impacting conditions. The way they do this is by increasing the level of serotonin in the brain (a chemical, or neurotransmitter, that regulates mood, appetite, and sleep). Since it isn’t quite as simple as just enhancing the amount of serotonin in the nervous system, the drug, in effect, keeps (inhibits) the brain from reabsorbing (reuptaking) serotonin. Because serotonin impacts mood, the drug’s ability to allow more serotonin to remain available results in a more balanced mood and state of mind in the user. The drugs are called selective because they seem to affect serotonin more than other similar neurotransmitters (chemicals) in the brain.

Developing science has indicated that the increased amount of serotonin in the bloodstream of pregnant women taking SSRIs can dramatically impact developing fetuses, oftentimes causing life-threatening birth defects. Unfortunately, while the pharmaceutical industry began to learn about the increased risk of birth defects to children exposed in utero to SSRIs as early as the 1990s, they failed to notify physicians or patients of these problems, or to warn pregnant women that their babies were at risk.

What brought you here

Birth defects from the mother’s usage of Zoloft, Effexor, Lexapro, Prozac, Cymbalta, and other SSRIs during pregnancy.

Zoloft

Zoloft (sertraline hydrochloride), an SSRI by Pfizer, treats depression, obsessive-compulsive disorder, panic disorder, and anxiety disorders, and was the most prescribed antidepressant in 2007 in the United States, with over 29 million prescriptions written.

Effexor

Effexor (venlafaxine), an SSRI by Pfizer, treats depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and in 2007 was the sixth most commonly prescribed antidepressant in the United States at 17.2 million prescriptions.

Lexapro

Lexapro (escitalopram), an SSRI by Forest Pharmaceuticals, treats depression and generalized anxiety disorder.

Prozac

Prozac (fluoxetine), an SSRI by Eli Lilly, treats depression, obsessive-compulsive disorder, select eating disorders, and recurrent panic attacks, and helps relieve the symptoms of premenstrual dysphoric disorder, a severe form of PMS, including mood swings, irritability, bloating, and breast tenderness. One of the oldest SSRIs still on the market, it received initial approval by the FDA in 1987. Prozac, the third most prescribed SSRI after Zoloft, is still widely-used; in 2010 over 24.4 million prescriptions were filled.

Cymbalta

Cymbalta (duloxetine), an SSRI by Eli Lilly, treats depression and generalized anxiety disorder, and symptoms of pain associated with diabetic neuropathy (damage to the nerves that results from high blood sugar in the body of diabetics) and fibromyalgia (long-term, full-body, joint pain). The drug has been shown to do well with symptoms of stress urinary incontinence (though it never received approval for treating that specific condition), as well as chronic pain of arthritis and the lower back.

Celexa

Celexa (citalopram), an SSRI by Forest Laboratories, Inc., treats depression and anxiety-related disorders, and has many off-label uses (or those not considered the primary target of treatment), including treatment of premenstrual dysphoric disorder (a more severe form of PMS), body dysmorphic disorder (a body image perception disorder), as well as greatly reducing the symptoms of diabetic neuropathy (damage to the nerves that results from high blood sugar in the body of diabetics), premature ejaculation, and post-stroke pathological crying.

The alert: FDA public health advisory

You can view the FDA Update in its entirety here

July 19, 2006

Two new studies . . . included women who had been treated with antidepressant drugs that act as selective serotonin reuptake inhibitors (SSRIs) or, in a few cases, other antidepressants. SSRI medications are the most commonly used drugs to treat depression in the U.S.

The first study illustrates the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. The authors followed pregnant women who in the past had major depression. During their pregnancy, some of these women were not feeling depressed and stopped taking their antidepressant medicines. Others stayed on their antidepressant medicines while pregnant. The women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were the women who continued to take their antidepressant medicine while pregnant. This study, by Lee Cohen and colleagues, was published February 1, 2006, in the Journal of the American Medical Association (JAMA).

A second study suggests there may be additional, risks of taking SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk in one drug versus another, and this risk has not so far been investigated by other researchers. The study, by Christina Chambers and colleagues, was published on February 9, 2006, in The New England Journal of Medicine.

The finding of PPHN in babies of mothers who used an SSRI antidepressant in the second half of pregnancy adds to concerns coming from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing. In addition, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiologic study suggesting that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects (see FDA Public Health Advisory for Paxil dated December 8, 2005).

Who brought you here

Pfizer (Zoloft, Effexor), GlaxoSmithKline (Paxil), Eli Lilly (Prozac, Symbyax, Cymbalta), Forest Laboratories (Celexa, Lexapro), and other manufacturers of SSRIs.

Defects your child may have

Clubbed foot, cleft lip/palate, persistent pulmonary hypertension, heart defects, skull defects, brain/spinal cord defects, abdominal or intestinal birth defects/omphalocele (i.e., the infant's abdominal organs stick out of the navel), autism spectrum disorders, anal atresia (closure of the anus).

In the news

• Despite Lawsuits and FDA Birth Defect Warning, Zoloft Remains on Market
• Pfizer sued by parents claiming Zoloft use caused birth defects
• Prescribing Zoloft and Other Antidepressants to a Fetus

 

What this means for you

Protect yourself.

You potentially deserve, and may be entitled to, some form of restitution for what has happened to your family. We would be more than happy to assist you in that effort. And though we know remuneration can only go so far, it makes a statement to others that you were wronged. Let us look into the details surrounding your particular situation. You may have a case.

Please call us at your convenience toll-free at 1-800-218-4858.