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Celexa Linked to Birth Defects

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Washington, DCThe headline, Celexa Linked to Birth Defects gives one pause, regardless of whether the reader is a parent or not. The idea that a drug—in this case an antidepressant—can be associated with such serious side effects is distressing, but at the same time status quo in a modern age governed by the mantra "the benefits outweigh the risks."

Never denying that there are risks.

In the case with Celexa, the potential for side effects is further muddied by the improper marketing activities the manufacturer, through its marketing arm, was accused of. Forest Pharmaceuticals, the wholly owned marketing subsidiary of Forest Laboratories, pleaded guilty in September of last year to criminal charges related to its marketing and manufacturing processes.

According to the April 22 issue of the St. Louis Post-Dispatch, Forest Pharmaceuticals agreed to pay $313 million to settle criminal and civil allegations stemming from accusations that the firm paid kickbacks to pediatricians who prescribed antidepressants to children. To that end, Forest Pharmaceuticals was accused of marketing Celexa and one other antidepressant to children and adolescents, in spite of the fact neither drug was ever approved for use with minors by the US Food and Drug Administration (FDA).

It was also alleged that senior executives at Forest Laboratories withheld a negative clinical study regarding Celexa and were untruthful about information pertaining to Celexa clinical trials communicated with physicians.

Various Celexa Articles have documented the troubles involving Forest Laboratories, Forest Pharmaceuticals and allegations of improper marketing. But lesser known are recent attempts by the US Department of Health and Human Services to force the chairman, president and CEO of Forest from the company. Howard Solomon, 83, serves all three roles and has been with Forest since 1977.

It should be noted that Solomon was never personally implicated in the alleged wrongdoings of his company. However, regulators have begun to quietly put pressure on top executives to exit their offices, under the threat that their organization would be pre-empted from participating as a supplier to Medicare or Medicaid. It is not known where that process currently stands in the Solomon case. It is also not known what the feds stand to gain by pursuing Solomon's ouster in this fashion.

In the meantime, regardless of allegations against the manufacturer of Celexa (now settled) over inappropriate marketing, is the link between Celexa and birth defects—specifically, PPHN (persistent pulmonary hypertension of the newborn), when the infant is exposed to Celexa in the womb by way of a mother being treated for depression. Thus the debate continues over whether it is more prudent to stop SSRI antidepressants like Celexa for the duration of a pregnancy for the benefit of the child, or maintain the drug in order to maintain the stability and equilibrium of the mother during a stressful time. It's a debate that will likely never have an end…

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