The study, recently published in the British Medical Journal, looked at the rate of persistent pulmonary hypertension, or PPHN, in babies born to women who took selective serotonin reuptake inhibitors, or SSRIs, during pregnancy. PPHN is a condition with high blood pressure in the lungs that leads to difficulties in breathing and can increase the risk for heart failure.

Normally, only one in three infants per 1,000 develop PPHN. However, researchers found a much more significant risk in women who took SSRIs during pregnancy, especially late in the fetus’ development. SSRIs include the brand names Paxil, Zoloft, Celexa, Lexapro and Prozac.

Researchers studied data that included 1.6 million births (33 weeks gestation or greater) in five Nordic countries between 1996 and 2007. A total of 1,618,255 singleton births were included in the study. Approximately 11,000 of the mothers filled prescriptions for antidepressants late in pregnancy, and about 17,000 of the mothers filled prescriptions for antidepressants in early pregnancy.

Researchers noted that out of 11,014 mothers who used SSRIs late in pregnancy, 33 babies were born with PPHN. Among the 17,053 mothers who used SSRIs during early pregnancy, 32 were born with SSRIs.

Attorneys with Beasley Allen Law Firm are currently investigating cases of birth defects of all kinds in children whose mothers took SSRIs during pregnancy.

Source: Psych Central

SOURCE: Paxil and Pregnancy › SSRI exposure late in pregnancy increases risk for PPHN

The plaintiffs allege that their children were born with varying birth defects including heart defects, neural tube defects, gastroschisis, omphalocele, craniosynostosis, cleft lip, club foot, anal atresia, and limb reduction defects. They blame the drug.

“Pfizer knew or should have known that Zoloft crosses the placenta, which could have important implications for the developing fetus,” the lawsuit states. The plaintiffs allege that Pfizer instead marketed Zoloft as the safest antidepressant to take during pregnancy.

Zoloft is in a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. Other drugs in this class include Paxil, Celexa, Lexapro, and Prozac. All SSRIs were classified as Category C pregnancy drugs, meaning that no studies have proven risks to developing fetuses. However, recent studies proving Paxil causes birth defects have required the reclassification of Paxil to a Category D pregnancy drug.

SSRIs are among the most prescribed medications in the country, and drug companies make millions off these drugs. The plaintiffs in the Zoloft lawsuit claim that Pfizer kept reports of complications in fetuses under wraps to protect its empire. The drug maker disputes these claims.

The lawsuit alleges strict products liability, breach of express warranty, negligence, misrepresentation by omission, negligent misrepresentation, fraud and misrepresentation, fraud by concealment, violation of consumer protection laws, and breach of implied warranties. The lawsuit seeks unspecified compensatory damages, statutory remedies, a disgorgement of profits and pre-judgment interests.

Attorneys with Beasley Allen Law Firm are currently investigating cases of birth defects allegedly associated with Zoloft and any other SSRI.

Source: The Madison St. Clair Record

SOURCE: Paxil and Pregnancy › Parents file birth defects lawsuit against makers of Zoloft

The study looked at data from 27,058 patients aged 50 and older who were discharged from the hospital after a heart attack between January 1998 and March 2007. Following discharge, 14,426of the patients took aspirin alone and 406 took both aspirin and an SSRI at the same time.

Patients taking both the aspirin and the SSRI had a 42 percent increased risk of experiencing a bleeding episode such as gastrointestinal bleeding, hemorrhagic stroke, or other bleeding that required hospitalization, compared with those taking aspirin only.

When researchers included the blood thinner clopidogrel with aspirin, the risk of bleeding increased to 49 percent beyond aspirin alone. The addition of an SSRI brought the risk to 57 percent.

Blood thinners are commonly prescribed following a heart attack, and antidepressants are often prescribed to treat depression in patients with cardiovascular disease. But the study’s authors advised caution.

SSRIs include the brand names Paxil, Zoloft, Lexapro, Celexa and Prozac. The drugs are currently being investigated by attorneys with Beasley Allen Law Firm for possibly increasing the risk of serious birth defects when used by women during pregnancy.

Source: Food Consumer

SOURCE: Paxil and Pregnancy › Aspirin + SSRIs = risk of bleeding

Pregnant women

The study involved nearly 3,000 women who gave birth in Washington state. Researchers found that those who started taking antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, in the second or third trimester were nearly five times more likely to give birth prematurely compared to pregnant women not on the medication.

SSRIs are prescribed for the treatment of depression and anxiety disorders and include drugs such as Zoloft (sertraline), Paxil (paroxetine), and Prozac (fluoxetine).

The study raises more concerns about the safety of SSRIs during pregnancy. A New England Journal of Medicine study found that women who took SSRIs during their third trimester were six times more likely to deliver babies born with persistent pulmonary hypertension (PPHN), a serious lung condition, than those who did not take SSRI during their third trimester.

More studies have linked SSRIs to omphalocele, a birth defect where the intestine or other abdominal organs protrude from the naval. Other birth defects that have been reported include cleft palate, club foot, spina bifida, anal atresia, and congenital heart defects.

Beasley Allen Law Firm is currently investigating cases of birth defects and birth complications  allegedly caused by SSRI use during pregnancy. These lawsuits may provide the financial resources necessary for a lifetime of care or to help pay for medical procedures for babies that may have been affected by the drugs.

Source: American Journal of Obstetrics & Gynecology

SOURCE: Paxil and Pregnancy › Study links SSRIs to preterm delivery and birth complications

“To say the least, I was absolutely distraught with this news. I thought this was something that I did … because I stayed on the Paxil for selfish reasons,” Beverly said. Despite the heartbreaking loss, Beverly and her husband were ready to try again to get pregnant. Her e-mail to GSK continued, “I don’t want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby, I want to know upfront. And I will somehow stop taking it for the time being.

“Please contact me as soon as possible. Please don’t forget about me.”

GSK never responded. Three weeks later, Beverly sent another e-mail, this time asking specifically, “I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.”

Five days later, Beverly got a response. GSK attached a copy of its current product information for Paxil, and then suggested she contact her physician or pharmacist with any questions.

Eight years later, the first Paxil birth defect trial resulted in a $2.5 million verdict against GSK. Since then, hundreds of lawsuits have been filed against GSK, and the FDA downgraded Paxil’s status from a Category C to a Category D drug, indicating clinical trials showed the drug caused birth defects in developing fetuses.

Paxil, an antidepressant in a class of drugs known as selective serotonin reuptake inhibitors, or SSRIs, is the only SSRI listed as a Category D drug. But new studies suggest that Zoloft, another SSRI, and others in the class, may be just as dangerous to fetuses when used by mothers during pregnancy.

Beasley Allen Law Firm is currently investigating cases where SSRIs may have caused birth defects.

*Name changed
Source: Unite for Life

SOURCE: Paxil and Pregnancy › GSK avoided questions about safety of Paxil during pregnancy

Paxil, manufactured by GlaxoSmithKline (GSK), is an antidepressant in a class of medications called selective serotonin reuptake inhibitors (SSRIs), which work by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance. It is used to treat depression, panic disorder, and social anxiety disorder. The medication is also used to treat chronic headaches, tingling in the hands and feet caused by diabetes, and certain male sexual problems. It is also used in combination with other medications to treat bipolar disorder. It may also be prescribed for other uses.

The drug’s safety label now warns patients that, “epidemiological studies have shown that infants born to women who had first trimester paroxetine exposure had an increased risk of cardiovascular malformations, primarily ventricular and atrial septal defects (VSDs and ASDs). In general, septal defects range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve spontaneously. If a patient becomes pregnant while taking paroxetine, she should be advised of the potential harm to the fetus. … For women who intend to become pregnant or are in their first trimester of pregnancy, paroxetine should only be initiated after consideration of the other available treatment options.”

In 2005, when the FDA first warned of the dangers with Paxil in women of childbearing age, GSK was ordered to change the pregnancy category of the drug from C to the stronger warning of D. Category D means that studies in pregnant women (controlled or observed) have demonstrated a risk to the fetus.

In 2010, a new study using the Swedish Medical Birth Register from July 1, 1995 to 2007 identified women who reported the use of antidepressants in early pregnancy or were prescribed antidepressants during pregnancy by antenatal care. Data showed a specific association between Paxil use and infant cardiovascular defects. There was also a strong association between Paxil and hypospadias, a birth defect of the urethra in male infants. The drug has also been associated with an increased risk for spontaneous miscarriage.

Beasley Allen Law Firm is currently investigating cases of birth defects caused by Paxil, or generic versions of the drug, known as paroxetine.

Source: FDA

SOURCE: Paxil and Pregnancy › New study shows Paxil during pregnancy causes heart defects