Send a Tweet
Most Popular Choices
Share on Facebook 9 Share on Twitter Printer Friendly Page More Sharing
General News    H4'ed 3/3/10

Cold Case Files - Paxil Birth Defects

By       (Page 17 of 19 pages) Become a premium member to see this article and all articles as one long page. (View How Many People Read This)   No comments
Author 38068
Message Evelyn Pringle

Under cross-examination, Glaxo attorney, Joe O'Neil, asked Parisian to identify the FDA regulation she was referring to in stating the reports should have been submitted to the FDA. "I would specifically use (21 CFR) 314.81," she said, "FDA talks about issues with children, information about children that they are to receive that information."


"Also, as a postmarket study asked (for) by the Japanese which is the 2000 report," she stated. "That would be under (21 CFR) 314.80."


While cross-examining Parisian, O'Neil put up a power point slide listing the FDA approvals of Paxil and Paxil CR, the controlled release version, for additional indications between the initial approval for major depression disorder in 1992 through 2004, including panic disorder, obsessive compulsive disorder, general anxiety disorder, and PSTD.


Several times, Parisian noted that Paxil was not approved for use by pregnant women. O'Neil pointed out that for each new indication, FDA approved the label and Paxil was never contraindicated for use by pregnant women on the label.


Under redirect examination, Parisian testified that when Glaxo applied for approval of the new indications, the FDA was not given the internal analysis of birth defects available at the time or told about Dr Baldwin's comments on the early animal studies.


Although the 2000 report with 79 cases of birth defects was supposedly done for the Japanese government, it was never given to the Japanese, Tracey told the jury in closing arguments. "It wasn't given to the people it was prepared for," he said.


And after the report in 2000, Glaxo stopped doing the pregnancy analysis, he said. "For the next five years we have nothing," he told the jury. "We don't have any reports. We don't know how many birth defects are reported to them."


FDA Stamped Paxil Label


Next Page  1  |  2  |  3  |  4  |  5  |  6  |  7  |  8  |  9  |  10  |  11  |  12  |  13  |  14  |  15  |  16  |  17  |  18  |  19

 

Rate It | View Ratings

Evelyn Pringle Social Media Pages: Facebook page url on login Profile not filled in       Twitter page url on login Profile not filled in       Linkedin page url on login Profile not filled in       Instagram page url on login Profile not filled in

Evelyn Pringle is an investigative journalist and researcher focused on exposing corruption in government and corporate America.
Go To Commenting
The views expressed herein are the sole responsibility of the author and do not necessarily reflect those of this website or its editors.
Writers Guidelines
Contact AuthorContact Author Contact EditorContact Editor Author PageView Authors' Articles
Support OpEdNews

OpEdNews depends upon can't survive without your help.

If you value this article and the work of OpEdNews, please either Donate or Purchase a premium membership.

STAY IN THE KNOW
If you've enjoyed this, sign up for our daily or weekly newsletter to get lots of great progressive content.
Daily Weekly     OpEdNews Newsletter
Name
Email
   (Opens new browser window)
 

Most Popular Articles by this Author:     (View All Most Popular Articles by this Author)

Tracking the American Epidemic of Mental Illness - Part II

Tracking the American Epidemic of Mental Illness - Part I

The Rise and Fall of Provigil -" Part I

The Rise and Fall of Provigil - Part II

Psychiatric Drugging of Infants and Toddlers in the US - Part I

Tracking the American Epidemic of Mental Illness - Part III

To View Comments or Join the Conversation: