On July 19, 2006, the FDA issued another Advisory after a study lead by Dr Christina Chambers in the February 9, 2006, New England Journal of Medicine, reported a 6-fold increased risk of the life-threatening lung disorder, persistent pulmonary hypertension, in babies born to mothers taking SSRI's and said, "the FDA has asked the sponsors of all SSRI's to change prescribing information to describe the potential risk for PPHN."

According to the FDA Advisory: "Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die."

The risk of PPHN was first found by Dr Chambers in a 1996 study where the researchers found 2 cases of PPHN, an unexpected finding since there were relatively few women in the study and both women had taken Prozac late in their pregnancies.

Warnings about the adverse effects of SSRI's in the patient information sheet on the FDA's web site as of July 13, 2007, states: "babies delivered to mothers taking Paxil late in pregnancy have developed problems, such as difficulty breathing and feeding."

"Babies delivered to mothers taking Paxil early in pregnancy are sometimes born with heart problems," it states.

The Web Site Also Warns:

"Persons taking Paxil may be more likely to think about killing themselves or actually try to do so, especially when Paxil is first started or the dose is changed."

"Paxil may cause bleeding problems," the FDA warns, "especially if taken with aspirin, NSAID's (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen) or other drugs that affect bleeding."

The information sheet also advises that Paxil patients, "may become hyperactive, excitable or elated," and, "have problems with impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire)."

Other side effects currently listed include weakness, dry mouth, constipation, yawning, infection, diarrhea, sweating, dizziness, tremor, nervousness, nausea, difficulty sleeping, decreased appetite and sleepiness.

According to Mr Bone, CNN is not the only guilty provider of misleading information about SSRI's. "Major broadcasting companies like CBS, FOX, ABC and NBC," he says, "are no longer worthy of trust when they shamelessly promote a class psychotropic drugs that threaten the public safety."

"Such promotion," he states, "constitutes a flagrant breach of basic television broadcasting ethics and fairness standards each and every time."

Mr Bone also says that the media should acknowledge whether the doctors featured in these segments have received grants or gratuity payments from SSRI's makers.

Risks Versus Benefits

Finally, experts point out that the headlines fail to disclose that SSRI's are ineffective. Clinical psychologist Dr Bruce Levine, author of a new book due out this fall entitled, "Surviving America's Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy," says, "legitimate science shows that these antidepressants are no more helpful for depression than a placebo or no treatment at all."

"Even the dice-loaded drug company studies show that antidepressants are, in a scientific sense, a failure," he notes.

"For example," Dr Levine points out, "in 2002 the journal Prevention & Treatment analyzed 47 studies that had been sponsored by drug companies on Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone, and it reported that in the majority of the trials, the antidepressant failed to outperform a sugar pill placebo."

Another of the world's leading authorities on SSRI's, Dr David Healy, also says that the effectiveness of SSRI's has been exaggerated, and the actual data reveals that only one in 10 patients on SSRI's can be shown to respond specifically to the drug rather than a nonspecific factor or a placebo.

Dr Healy is the author of numerous books on psychiatric drugs including, "The Antidepressant Era" and "The Creation of Psychopharmacology."

He says that, in prescribing SSRI's to pregnant women, he is concerned about "the benefit-harm trade-off," because "without any benefits, the child runs all the risks including the neonatal withdrawal syndrome and birth defects."

Dr Healy points out that the CDC study focuses on linking particular specific defects to particular drugs, and once you do this, "you end up with very small numbers in each group and not a lot of significant findings," he says.

Families seeking legal advice regarding SSRI birth defects can contact the Baum, Hedlund, Aristei, Goldman & Menzies Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/

Evelyn Pringle
evelyn-pringle@sbcglobal.net

(Written as part of the Antidepressant Birth Defect Litigation Monthly Round-Up, Sponsored by Baum Hedlund's Pharmaceutical Antidepressant Litigation Department)

www.paxilbirthdefect.com/
www.pphnlawyers.com

(Evelyn Pringle is a regular columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America)

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