February 9, 2006. By Evelyn Pringle
lawyersandsettlements.com
New research has linked the use of SSRIs during pregnancy to a complication in newborns of a rare but life-threatening lung problem, according to this month's New England Journal of Medicine. Infants born to women who took the drugs in the second half of their pregnancy, had 6 times the risk of developing the disorder, the researchers reported.
Only a couple of days ago on February 7, 2006, WebMD reported a new study from Israel, in which about one out of three newborns exposed to antidepressants in the womb showed signs of neonatal drug withdrawal, which included high-pitched crying, tremors, and disturbed sleep.
The Israel study involved 60 newborns whose mothers took SSRIs throughout their pregnancies and reported that 18, or 30%, of the newborns showed signs of drug withdrawal after birth, and in eight cases the symptoms were considered severe.
But then what's new? A study conducted a year ago at a University in Spain determined that, "drugs known as selective reuptake inhibitors (SSRIs) can cause convulsions, irritability, abnormal crying and tremors."
For this study, researchers accessed the World Health Organization's database on adverse reactions and withdrawal symptoms in infants associated with the use of SSRIs from 72 countries, according to the February 15, 2005, Epoch Times
"Risks of neonatal convulsions and neonatal withdrawal syndrome seem to be increased with all SSRIs," said Professor Emilio Sanz, the leader of the study, of the University of La Laguna in Tenerife.
In February 2004, another study reported that "first-trimester use of SSRIs has been associated with higher rates minor physical anomalies and miscarriages, thus suggesting possible early effects of SSRI exposure on embryonic development," according to Maternal Selective Serotonin Reuptake Inhibitor, Philip Sanford Zeskind, PhD and Laura E Stephens, Pediatrics Vol 113 No 2 February 2004, pp. 368-375.
The same study said that third-trimester use off SSRIs has been associated with lower gestational age, low birth weight, higher rates of neonatal intensive care unit admissions. A 2004 study in France published in Prescrire Int. 2004 Jun;13(71):103-4, in summary reported:
(1) Newborns exposed to SSRI during pregnancy show signs of agitation, altered muscle tone, and breathing and suction problems.
(2) symptoms have been noted with all five SSRI antidepressants.
(3) 20% to 30% of newborns are affected.
(4) The symptoms are variously attributed to withdrawal or to the drug itself. (5) doctors should be aware of this risk when considering antidepressant treatment for women in the third trimester of pregnancy. PMID: 15233148 [PubMed - indexed for MEDLINE]
In July 2004, the FDA moved to alter labeling for the entire class of SSRI of drugs, warning that some newborns exposed to SSRIs and Effexor have developed problems requiring prolonged hospitalizations, respiratory support, and tube feeding.
"The agency has received hundreds of preliminary reports of adverse effects in newborns over the last decade," WebMd reported on June 9, 2004. The most common include trouble eating, irritability, body rigidity, and respiratory trouble, said Kathleen Phelan, a safety evaluator in the FDA's division of drug risk evaluation too WebMD.
But this is nothing new either. Researchers have been reporting the risks of using these drugs during pregnancy for years, but the media has chosen not to inform the public.
Back in 1996, a study published in the New England Journal of Medicine identified 228 pregnant women on the SSRI Prozac during the period of 1989 through 1995, and compared the outcomes of their pregnancies to 254 women who were not taking Prozac.
The study determined that infants exposed to Prozac in the womb during the third trimester of pregnancy had significantly higher rates of premature delivery, admissions to special-care nurseries, and poor neonatal adaptation, including respiratory difficulty, cyanosis on feeding and jitteriness. Birth weight was also lower and birth length was shorter in infants exposed to Prozac, according to Chambers CD, Johnson KA, Dick LM, Felix RJ, Jones KL. Birth outcomes in pregnant women taking fluoxetine. N Engl J Med.1996; 335 :1010 -1015
In 2003 a study warned about SSRIs making their way into the womb: "These psychotropic medications readily cross the placental barrier and expose the infant to increased serotonin levels during early development," by Hendrick V, Stowe Z, Altshuler L, Hwang S, Lee E, Haynes D, Am J Psychiatry.2003; 160:993 -996
A new risk was made public on December 8, 2005, when the FDA issued an alert to health care professionals and patients about the results of new studies on Paxil that found the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy.
The first study, was an evaluation of US health insurer information, and found that about 2% of women who took Paxil in the first trimester of pregnancy gave birth to infants with heart defects, compared to about 1% of women in the general population. The second study, was conducted in Sweden, and examined records from close to 7,000 newborns and found that 1.5% of women taking Paxil in the first 3 months, delivered infants with heart defects, compared to 1% of women who took other antidepressants.
Most of the defects reported were "atrial and ventricular septal defects" which means "holes in the walls of the chambers of the hear," according to the FDA.
Paxil was approved by the FDA in 1993, and due to aggressive marketing campaigns by drug maker, GlaxoSmithKline, it quickly became one of the world's most popular drugs. Paxil is now also sold under the generic name paroxetine.
The FDA has now ordered Glaxo, to change the pregnancy category from C to the stronger category D, which signals that studies in pregnant women have demonstrated a risk to the fetus.
"Women taking Paxil who are pregnant or plan to become pregnant," the FDA warned in its December 8 the advisory, "should talk to their physicians about the potential risks of taking the drug during pregnancy."
The agency also said, that health care professionals should consider discontinuing Paxil and switching to another antidepressant if indicated in these patients.
Good luck to pregnant women who think for one minute about trying to educate a health care professional on the dangers of SSRIs. This can prove to be quite a feat according to new mother, Christine Kelly.
Although her pregnancy was somewhat of a surprise, it did not take long for Christine to get excited about the prospect of the arrival of new baby.
But there was one issue that she was concerned about. Christine was on Paxil and had been on several different SSRIs in the years before she become pregnant. At her next appointment with her psychiatrist, she mentioned her concerns and the psychiatrist assured Christine that there was nothing to worry about and advised her to keep taking the drug.
A few of Christine's friends and family members disagreed with the psychiatrist and offered up news reports on the potential harm of SSRIs on the fetus. The articles showed that warnings of the adverse effects had been in the news off and on for years already.
Christine brought copies of a couple of articles to her next appointment with the psychiatrist and when she mentioned the topic once again, the doctor was clearly annoyed. It was clear that the
doctor was not going to review the information.
Thus the battle began. The young pregnant mother concerned about her unborn child and the know-it-all mental health professional who acted as if her patient was being irrational.
By this time, Christine found herself in between a rock and a hard place. As she reviewed more information on the dangers of SSRIs, she became more alarmed.
"On the one hand," she said, "the SSRIs were said to cause birth defects if taken in the first 3 months of pregnancy and I was past the 3 month period."
"But then I read another report that said babies go through withdrawal at birth if the mother take an SSRI during the last 3 months of pregnancy," she continued.
Christine knew it was too late to better the odds for a normal birth due to taking Paxil during the first trimester, but she could improve the odds for the last 3 months of her pregnancy.
"The baby was not due for 4 more months so I decided to quit taking the drug," she said.
Christine would soon learn that the matter was not quite that simple. Abrupt withdrawal from these drugs has its own problems.
"I had been on SSRIs for 7 years," Christine said, "and according to reports on the internet, if I quit taking the drug, there was a good chance that I would go into withdrawal."
With no help or support from the know-it-all shrink, Christine recruited her friends and family members to help wean her off the drug. The process took less than 2 weeks and went off without a hitch.
After going off the drug, Christine hoped that her unborn child would be home free. But that was not the be. The baby ended up having to stay in the neonatal intensive care unit for 4 days while medical professionals monitored him for signs of withdrawal or adverse side effects of Paxil.
"There was also a problem with his sucking and he had to be fed intravenously with tubes," Christine said.
So instead of bringing her baby home, Christine sat at the hospital and watched her son Nicholas in a glass bed with tubes, needles and monitors stuck all over his little body.
Although the extra out-of-pocket costs associated with the intensive care unit put a strain on the household budget, the good news was that the baby appeared not to have suffered any lasting adverse effects from the SSRI.
When Christine met with her psychiatrist at her next appointment, she explained how Nicholas had to be monitored and kept in intensive care, and this time it was Christine's turn to get annoyed at the doctor.
Not willing to budge an inch, according to Christine, and implying that she had been right all the long, the doctor said, "well, was there anything wrong with him?"
"You're missing the point," Christine told her, "I feel very lucky that my baby is all right but you were wrong to tell me that nothing could happen to him if I kept taking the drug."
Once he was released from the hospital, everyone who came to visit agreed that he looked just fine.
Nicholas did not seem sleep like her other babies and woke up 2 or 3 times every night. "I just thought each baby is different," Christine said.
A short time after Nicholas got home, people began to notice that he was easily startled, even while asleep. "Any sudden little sound caused him to jump," Christine said.
At first it was sort of comical and people who saw him jump made light-hearted jokes about it. "His grandma kept laughing and saying it was a sign of good hearing," Christine said.
However, it was not comical after Christine spent time on the internet reading about the side effects of SSRIs on babies and found "easily startled" near the top of the list.
"The sucking problem Nicholas had at birth was also on the list," Christine said, "and abnormal sleeping patters were mentioned as well," she noted.
With each new headline that warns about the adverse effect of SSRI exposure to babies, Christine becomes more worried about the possible long-term effects on Nicholas.
His sleeping patterns remain erratic at 4 months old, and "he still jumps at the slightest sound," she reports.
In addition the potential risk of harm to the fetus in the womb, the public needs consider the risk of harm caused by a mother's use of antidepressants after birth. Bonnie Leitsch is the founder of the "Prozac Survivors Support Group," and Dr Anne Blake Tracy, author of "Prozac: Panacea or Pandora?" is a well-known expert on SSRIs, who has served as a consultant in many high-profile cases involving drug induced violent acts. These two ladies can cite case after case of mothers who have killed their babies while on antidepressants.
For instance, they report, Zoloft was found by investigators in the apartment of Emiri Padron, after she smothered her baby on June 22, 2004, and then stabbed herself twice in the chest.
On July 26, 2004, new mother, Mary Ellen Moffitt, suffocated her 5-week-old infant and killed herself after she had been diagnosed with postpartum depression and prescribed Paxil.
In a case that most people have heard about, Andrea Yates drowned all five of her children in the bathtub while taking Effexor and Remeron in November 2004.
In October 2002, Annie Mae Haskew smothered her 10-week-old baby after being diagnosed with postpartum depression and placed on antidepressants.
The public, and most importantly the medical professionals who pass out SSRIs like Halloween candy, need to understand that these drugs are known to cause grave harm to patients in all age groups, but have the potential to be lethal in the womb and beyond.
"The scientific evidence behind this has been out there for decades," says Dr Tracy, "All anyone ever had to do was read it."
