Generic Paxil Suicide Lawsuit

Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Monday, June 04, 2007

Seroxat/Paxil - Class B or not Class B?

FDA Classification System

Class A: These medications have been proven to be safe in pregnancy.

Class B: These medications are considered safe during pregnancy, although definitive evidence in humans is lacking.

Class C: These medications are considered potentially harmful, based on animal studies. No information from human studies is available.

Class D: These medications have been shown to be harmful to human fetuses.

Class X: These medications are contraindicated in women who are or may become pregnant.

2003 - Paxil/Seroxat (Paroxetine) - FDA Class B. Probably safe.

Release Date: May 31, 2006

The US Food and Drug Administration (FDA) approved in February safety labeling revisions to advise that maternal exposure to paroxetine HCl products during early pregnancy may be linked to an increased risk for fetal harm; treatment with doxazosin mesylate or other alpha-1 blockers has been linked to a risk for intraoperative floppy iris syndrome during cataract surgery; and off-label use of olanzapine products in elderly patients with dementia-related psychosis may be linked to an increased risk for mortality.

Manie had open heart surgery when he was 8 days old. Manie had an arterial switch. Because of the surgery Manie has a leaky valve. Manie's surgery lasted 12 hrs.

Manie is 3 years old.

Was born with Transposition of the Great Arteries.

Had a balloon procedure shortly after birth to keep him alive.

Had open heart surgery at 1 week old.

Had 3 cardiac caths to correct problems with collaterals.

Has had several coils put in his collaterals.

Has a leak in his valve.

Manie has to take medicine for high blood pressure.

Manie has also suffered from acid reflux

Manie was on an adult dose of meds for acid reflux for six months.

Because of the acid reflux Manie has bad teeth.

His baby teeth are ruined.

When Manie goes to the dentist he has to have dental work done with out Novocaine or nitrous oxide.

According to Mosbys 2003 Drug Reference here are the definitions for categories for prescribing medication to pregnant women.

What is a category B:

No adverse effects in animals, no human studies available.

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