New York, NYPaxil appears to be among those drugs that might qualify under "damned-if-you-do, damned-if-you-don't" status. Paxil side effects are many and varied, serving as a trigger for many a Paxil lawsuit. And yet, in spite of continued warnings by the US Food and Drug Administration (FDA) that link the antidepressant to such adverse reactions as birth defects, proponents continue to sing its praises and the debate continues…
Paxil is an antidepressant in the SSRI class that has found an important and valued niche with individuals suffering from severe depression. While there have been bumps in the road—not the least of which involve revelations of erratic behaviors on the part of some Paxil patients—the drug has served its constituents well.
But not without side effects, and of those the worst and most heartbreaking is the link to potential Paxil heart defects in newborns. The FDA, in fact, has included Paxil on a list of SSRI antidepressants that are dangerous to women who are pregnant or might become pregnant.
And therein lay the debate, which raged as late as mid-January on the pages of The New York Times, after a recent study published in the British Medical Journal summarized evidence that taking SSRI antidepressants during pregnancy doubles the risk of pulmonary hypertension in infants.
That study was based on data collected from 1.6 million births over a 10-year period, and suggested the risk was even higher when SSRI drugs (including Paxil) were taken toward the latter stages of pregnancy.
The risk is small, about 3 in 1,000 births. But for those infants negatively impacted by Paxil birth defects, the outcome can be devastating. Deaths have been reported. While doctors say PPHN can be treated in some cases, there can be issues that haunt the infant for the remainder of his or her natural life.
Dr. Ariela Frieder, a psychiatrist at Montefiore Medical Center, indicated in comments to The New York Times (1/13/12) that she had yet to see a PPHN infant amongst her patients being treated for depression. "I think this is a very good study," she said, "but the problem is always that you cannot separate the risks of the severe depression itself with the risks of the medication. And the risks here are still small. Women who have lived with severe depression know how hard it is to live with."
There are those in the medical community, however, who feel there remains a void when it comes to disseminating information to the patient, in some cases. Women, who might be in a position to handle a lower SSRI dosage—or stop their medication completely for their pregnancy or during a critical period, sometimes do not have that option articulated to them.
And there is little disagreement that depression is a serious problem that could worsen significantly if drugs counted on to manage the condition are minimized or abruptly stopped.
Thus the debate over which is worse—risk to the mother if an SSRI drug such as Paxil is stopped or risk to the infant if the drug is maintained, with a corresponding risk for Paxil birth defects.
Dr. Frieder is quick to point out that in her practice, medication is usually a treatment of last resort if other treatment options, such as psychotherapy, fail. And the debate, said Dr. Kimberly Yonkers in comments to The New York Times in 2009, has been around since antidepressants first came onto the market. "There's not a one-size-fits-all answer," she said at the time, adding that treatment decisions must be made on a case-by-case basis.
To that end, for some, depression is temporary. For others, it may be chronic. Then there is the "involuntary intoxication" experienced by one Paxil patient who was adversely affected by his medication when he robbed a bank in the state of Georgia, according to the man's attorney in comments published by the Atlanta Business Chronicle (1/24/12).
There's little doubt that depression is complex and hard to treat. The real tragedy is when a medication that could be reduced, or stopped temporarily in some patients, results in Paxil heart defects in infants that could haunt them for a lifetime.
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