Paxil Now An FDA Category “D” Drug: Attorney Explains How This Affects Birth Defect Lawsuits

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Jeffrey Johnson is a legal writer with a focus on personal injury. He has worked on personal injury and sovereign immunity litigation in addition to experience in family, estate, and criminal law. He earned a J.D. from the University of Baltimore and has worked in legal offices and non-profits in Maryland, Texas, and North Carolina. He has also earned an MFA in screenwriting from Chapman Univer...

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UPDATED: Jul 16, 2021

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GlaxoSmithKline’s (GSK) antidepressant Paxil recently became an FDA (U.S. Food & Drug Administration) category D drug. This designation tells doctors that the drug causes birth defects. Our legal expert explains how this change affects the hundreds of Paxil birth defect lawsuits filed across the nation.

Category D tells doctors that drug causes birth defects

Bryan Aylstock, a Florida attorney whose practice represents parents and their children who have suffered birth defect injuries due to Paxil use, says that a category D drug has special significance to prescribing doctors. He explained:

There have been a number of label changes over the years. Paxil, for example, is now a category D drug. For many years, up until very recently, it was a category C drug. The significance of the categories is this; the FDA created these categories to allow busy doctors to very quickly determine what the risks are for a particular drug.

A category D has a special significance to prescribing doctors. It tells them that a drug does cause birth defects. It’s not a contraindication for ever using it, which would be a category X, but it means that you should use it with extreme caution as the drug has been associated with birth defects and that it should only be prescribed if you know that the risks are outweighed by the benefits of the drug.

FDA didn’t do own testing on Paxil & Zoloft

Aylstock says the the FDA does not do its own testing in the vast majority of pharmaceutical cases and that it did not do its own testing on either Paxil or Zoloft – so the FDA is only as good as the information that it has been given. He explained:

Once [the FDA] learned that these drugs can cause birth defects, it asked the drug companies to change their labels. It doesn’t have the power to force it, but it can certainly ask. Eventually, the label changes did wind their way through the FDA. There are a number of publications from governmental agencies that agree that Paxil, for example, is the most prescribed teratogen – which is the agent that causes birth defects.

So, the FDA responded to the information that it had when it had it. However, I think the evidence at trial is going to show that the drug companies did not respond appropriately. In fact, I believe [drug companies] responded very negligently, even recklessly, in what they did with the information that they had.

GSK knew of Paxil risks, but failed to warn consumers

Paxil only recently became category D, according to Aylstock, so a lot of cases that have been winding their way through the court systems were before that designation change by the drug manufacturer. He explained the significance of that:

It’s our contention, and juries have also found, that it should have been a category D earlier because the drug companies knew – or they certainly should have known – that this was associated with these birth defects. They should have warned about it and they didn’t.

The foregoing article has been prepared by an attorney who is a regular contributor to FreeAdvice, and is now undergoing review by the site’s editorial staff.

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