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LAWSUITS NEWS & LEGAL INFORMATION

How Much 'Well' is Associated With Wellbutrin?

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Washington, DCThere appears to be some disconnect as to just what FDA pregnancy category Wellbutrin is assigned to. Most sources hold that the drug is categorized as 'C', which is described by the Journal of Counseling and Development (JCD) as posing a potential risk to the fetus that cannot be ruled out, due to the fact that animal-based studies have shown adverse effects on the fetus, but that no well-controlled studies on pregnant women have shown conclusive results.

However, in the same breath the JCD notes that Wellbutrin is classed as Category 'B', described by them as having no evidence of risk in humans.

What everyone can agree on, it appears, is that psychotropic drugs such as antidepressants cross the placenta. It is for this reason that the US Food and Drug Administration (FDA) does not approve antidepressants for use by pregnant women, due to the concern for potential Wellbutrin birth defects.

That said, given the rise in the percentage of women who continue on with antidepressants during pregnancy, together with the medical authority on the part of doctors to prescribe such medications off-label to benefit their patients, the FDA has at least acknowledged the situation by issuing a black box warning with regard to the potential for suicidal behavior and suicidality in children and adolescents with MDD and other psychiatric disorders.

Wellbutrin does not carry FDA approval for treatment of depression in children, as it could make that depression worse.

Judging by various postings to blog sites by Wellbutrin patients, such concerns over anxiety and deepening depression are well founded even in adults.

A patient named Steve noted that after five months of taking Wellbutrin SR 150mg he experienced "up and down results" along with heavy side effects. When his doctor upped Steve's dosage to 300mg per day, Steve described going downhill "very fast."

Wellbutrin patient Adrian noted that he suffered from a panic disorder, and described his situation as 'tearing up' at just about anything and everything since starting on Wellbutrin XL.

As for Wellbutrin and pregnancy, SafeFetus.com duly highlights Wellbutrin in Category C as an FDA Pregnancy Risk factor, with an increase in congenital defects reported without fetotoxicity in animals. With limited human data reported, use of Wellbutrin during the first trimester was found to be without teratogenic effects. SafeFetus.com, a resource for pregnant women and mothers-to-be, notes the observation that Wellbutrin is excreted into breast milk, and that the effects on nursing infants—including Wellbutrin adverse effects—are unknown.

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