Most of the heart defects reported were atrial and ventricular septal defects or holes in the walls of the chambers of the heart, the FDA advised.
In general, according to the FDA, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.
In light of these findings, the FDA told Glaxo to change the pregnancy warning on Paxil labeling from C to the stronger category D, which means that studies in pregnant women have demonstrated a risk to the fetus.
"FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil," the agency's advisory said, "who plan to become pregnant or are in their first three months of pregnancy."
"FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy," the advisory warned, "unless other treatment options are not appropriate."
In December 2005, Glaxo also notified healthcare professionals about information added to the labeling of Paxil about the risk of major congenital malformations in infants born to women taking Paxil during the first trimester of pregnancy.
Paxil has long been associated with difficult withdrawal side effects, leaving patients virtually addicted to the drug. But a study in the February 5, 2006, Lancet reported evidence that babies born to mothers who take SSRIs during pregnancy experience symptoms of withdrawal at birth.
The study involved 60 infants whose mothers took SSRIs throughout their pregnancies and a second group of 60 infants who were not exposed to SSRIs in the womb. The researchers determined that about one out of three newborns exposed to SSRIs in the womb showed signs of neonatal drug withdrawal.
The newborns were assessed for signs of withdrawal during the first two hours after birth, and then again at regular intervals if they exhibited initial signs of withdrawal.
The researchers found 18 of the newborns, or about 30%, exhibited signs of withdrawal in the hours after birth, and in eight cases the symptoms were considered severe. The most common symptoms included tremors, sleep disturbances, gastrointestinal problems, muscle tensing, and high-pitched crying.
None of the infants who were not exposed to SSRIs had symptoms.
The researchers concluded that babies born to mothers taking SSRIs should be watched in the hospital setting for at least 48 hours following birth and expectant mothers and their doctors should be warned about the potential risk.
"Because maternal depression during pregnancy also entails a risk to the newborn, the risk-benefit ratio of continuing SSRI treatment should be assessed," Dr Rachel Levinson-Castiel, MD, and colleagues wrote.
Another study, published on February 6, 2006, in the Archives of Pediatrics & Adolescent Medicine, also determined that newborns whose mothers had used SSRIs during pregnancy showed an increased risk of symptoms associated withdrawal such as high-pitched crying, tremors, gastrointestinal problems and disturbed sleep. The study found that 13% of the 60 newborns exposed to SSRIs showed severe withdrawal symptoms.
Research results published in the February 9, 2006 New England Journal of Medicine found that mothers who took SSRIs, in the second half of their pregnancies were 6 times more likely to give birth to infants with a lung disorder called persistent pulmonary hypertension (PPHN).
The condition occurs when a newborn's circulation system does not adapt to breathing outside the womb and causes high pressure in the blood vessels of the lungs making them unable to get enough oxygen into their bloodstream and can be fatal.
In general, according to the FDA, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.
In light of these findings, the FDA told Glaxo to change the pregnancy warning on Paxil labeling from C to the stronger category D, which means that studies in pregnant women have demonstrated a risk to the fetus.
"FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil," the agency's advisory said, "who plan to become pregnant or are in their first three months of pregnancy."
In December 2005, Glaxo also notified healthcare professionals about information added to the labeling of Paxil about the risk of major congenital malformations in infants born to women taking Paxil during the first trimester of pregnancy.
Paxil has long been associated with difficult withdrawal side effects, leaving patients virtually addicted to the drug. But a study in the February 5, 2006, Lancet reported evidence that babies born to mothers who take SSRIs during pregnancy experience symptoms of withdrawal at birth.
The study involved 60 infants whose mothers took SSRIs throughout their pregnancies and a second group of 60 infants who were not exposed to SSRIs in the womb. The researchers determined that about one out of three newborns exposed to SSRIs in the womb showed signs of neonatal drug withdrawal.
The newborns were assessed for signs of withdrawal during the first two hours after birth, and then again at regular intervals if they exhibited initial signs of withdrawal.
The researchers found 18 of the newborns, or about 30%, exhibited signs of withdrawal in the hours after birth, and in eight cases the symptoms were considered severe. The most common symptoms included tremors, sleep disturbances, gastrointestinal problems, muscle tensing, and high-pitched crying.
None of the infants who were not exposed to SSRIs had symptoms.
The researchers concluded that babies born to mothers taking SSRIs should be watched in the hospital setting for at least 48 hours following birth and expectant mothers and their doctors should be warned about the potential risk.
"Because maternal depression during pregnancy also entails a risk to the newborn, the risk-benefit ratio of continuing SSRI treatment should be assessed," Dr Rachel Levinson-Castiel, MD, and colleagues wrote.
Another study, published on February 6, 2006, in the Archives of Pediatrics & Adolescent Medicine, also determined that newborns whose mothers had used SSRIs during pregnancy showed an increased risk of symptoms associated withdrawal such as high-pitched crying, tremors, gastrointestinal problems and disturbed sleep. The study found that 13% of the 60 newborns exposed to SSRIs showed severe withdrawal symptoms.
Research results published in the February 9, 2006 New England Journal of Medicine found that mothers who took SSRIs, in the second half of their pregnancies were 6 times more likely to give birth to infants with a lung disorder called persistent pulmonary hypertension (PPHN).
The condition occurs when a newborn's circulation system does not adapt to breathing outside the womb and causes high pressure in the blood vessels of the lungs making them unable to get enough oxygen into their bloodstream and can be fatal.
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