downers during pregnancy harm baby

Women who are pregnant and taking certain antidepressants take note: a recent study finds that you are more likely to have a recurrence of depression if you stop treatment during pregnancy, but another recent study suggests that taking certain antidepressants may harm your baby.

WARNING: Withdrawal Reactions With Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants

A withdrawal reaction has been reported with all SSRI antidepressants: citalopram (CELEXA); escitalopram (LEXAPRO), fluoxetine (PROZAC, SARAFEM); fluvoxamine (LUVOX); paroxetine (PAXIL); and sertraline (ZOLOFT). The symptoms generally start within one to three days after stopping the drug and generally resolve within one to two weeks after the drug has been discontinued. Withdrawal symptoms may occur even when the dosage of the drug is gradually decreased. The main symptoms of this reaction are dizziness, vertigo, lack of coordination, nausea and vomiting, and flu like symptoms that include fatigue, lethargy, muscle pain and chills. {Obviously with such side effects depression is going to be much more likely—jk}

The Food and Drug Administration (FDA) alerted consumers and health professionals on July 19 about the results of studies, which included women treated with the antidepressants selective serotonin reuptake inhibitors (SSRIs) and, in a few cases, selective serotonin/norepinephrine reuptake inhibitors (SNRIs).

The first study cited by the FDA found that women who stopped their SSRI antidepressants were five times more likely to have a recurrence of depression [in the first couple of weeks] than women who continued antidepressant treatment while pregnant.

This study was published February 1 in the Journal of the American Medical Association and was funded by the National Institute of Mental Health (NIMH), a part of the National Institutes of Health. The NIMH had no part in the design and conduct of the study, or in the collection, analysis, interpretation of the data, nor in the preparation, review or approval of the final published manuscript.

Two of the 13 authors reported financial ties to drug companies producing antidepressants. However, according to the July 11 Wall Street Journal, most of the 13 authors of this study are paid speakers or consultants hired by drug companies that make antidepressants.

The Wall Street Journal article says that the study’s lead author, Dr. Lee S. Cohen, a longtime consultant to antidepressant makers, and some of his coauthors have hit the lecture circuit, touting their findings. At the same time, these researchers have been spotlighting flaws in other recent studies (see below) that have found increased risks to babies born to mothers who use antidepressants during pregnancy. [Hardly seems like a group of neutral scientists.]

The Wall Street Journal article says that the study’s lead author, Dr. Lee S. Cohen, a longtime consultant to antidepressant makers, and some of his coauthors have hit the lecture circuit, touting their findings. At the same time, these researchers have been spotlighting flaws in other recent studies (see below) that have found increased risks to babies born to mothers who use antidepressants during pregnancy.

Other problems

The FDA had previously alerted the public to some other problems identified in babies whose mothers used antidepressants during pregnancy.

The FDA announced that the professional product label, or package insert, for the SNRI antidepressant venlafaxine was changed on June 3, 2004, to say that babies of mothers who used the drug in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support and tube feeding.

In addition, the FDA notified healthcare professionals on September 27, 2005, that the professional product labeling, or package insert, for paroxetine was amended to warn of major congenital malformations (birth defects), primarily heart malformations, in children born to mothers taking the drug during their first trimester of pregnancy.

This warning was based on a study that the FDA had asked GlaxoSmithKline, the manufacturer of paroxetine, to conduct. The results suggested a more than two-fold increase in the risk of major congenital malformations when paroxetine was taken compared to other antidepressants. This study has not been published, but a more complete description of the study can be found on GlaxoSmithKline’s Web site at http://ctr.gsk.co.uk/Summary/paroxetine/epip083.pdf (see Worst Pills, Best Pills News December 2005 ).

In the October 2004 issue of Worst Pills, Best Pills News , Public Citizen alerted readers that the Canadian equivalent of the FDA, Health Canada, issued a public advisory on August 9, 2004, warning that newborns may be adversely affected when their mothers take SSRIs, SNRIs or other newer antidepressants during the third trimester of pregnancy. The symptoms reported in these babies included either feeding or breathing difficulties or both, seizures, muscle rigidity, jitteriness and constant crying.

Depression in pregnant women is growing, as is the list of potential harms to newborns whose mothers are treated with antidepressants. This makes the decision to take, or not to take, one of these drugs during pregnancy much more difficult for women and their physicians.

Do Not Use Ibandronate (BONIVA) For Osteoporosis Until May 2010
(October 2006)
Although this osteoporosis drug has been shown to decrease vertebral fractures, which involve the bones that make up the spine, the drug did not show any decrease in nonvertebral fractures, such as hip fractures, in postmenopausal women. We know more about the older, alternative drugs for osteoporosis.

This is another typical example of how a drug only has to demonstrate some limited effectiveness (better than a placebo) for FDA approval. However, this drug has been approved for all types of osteoporosis.

A second problem is that drug companies thus normally test drugs in their clinical trials for various usages, get approval for one, and then have their sales personnel encourage doctors to proscribe the drug for off label treatments--jk.

Two things are disconcerting: One is the failure to deal with the issue of these drugs crossing the placenta and its health consequences. It has been know for three decades that barbiturates (another antidepressant) significantly affected the growth rate of the infant. The second is the appointment of pro big PHARMA people at the top of the FDA, and thus in all lower position including the research and review panel. As a consequence of their unscientific bias, they study failed to look for consequences counter to PHARMA’s financial interests, such as the increase in weight and birth weight of the infants. Their bias was further demonstrated by the fact that “most of the 13 authors hit the lecture circuit, touting their finding” (below). One final comment, though women were much more likely to have an additional bout of depression when taken off the downers (the norm for taking a person off a psychotropic drug, including recreational drugs), there was no long-term statistics generated by the study—another case of don’t-look-don’t find--jk.

For the best darn book on big Pharma.