Court transcripts hosted here – Glaxo guilty of not warning of the dangers of Seroxat to pregnant women

After analyzing a 2001 e-mail from a Paxil user who aborted her fetus because it had a heart defect, Glaxo officials noted in company files they were “almost certain” the drug was related to the problem, Jane Nieman, a former Glaxo drug-safety executive, told a Pennsylvania jury.

Now that Glaxo has been found guilty and Kilker case has ended, pending an appeal of course,  what of the remaining court documents that have yet to surface?

READ THEM ALL HERE!

Seroxat: no, really it’s safe… all that happened was someone ticked the wrong box on a form, says Glaxo…

Yes – this really was part of Glaxo’s defence: “… In court, senior GSK officers in court said this apparent admission that the drug was responsible for the defects in the aborted baby was a mistake. They told the court somebody must have ticked the wrong box…”

Read the rest of the story from Sarah Bosely at the Guardian:

A jury in the US today found that Seroxat (known as Paxil in the US), the antidepressant made by the British pharmaceutical company GlaxoSmithKline (GSK), was responsible for heart defects Lyam Kilker developed in the womb while his mother was taking the medication. Lyam’s family was awarded $2.5 million (£1.6m) in damages.

The following documents, disclosed by GSK, were cited in court by lawyers representing the family of three-year-old Lyam, as evidence to back up their claim that pharmaceutical company GSK knew about the problems with Paxil back in 2001.

This first email is from an unidentified woman (not Lyam Kilker’s mother) to GSK at the end of May 2001.

“I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I’ve been taking Paxil, which is truly a miracle drug. I’ve been panic-free with this drug and have been able to go on with a normal life.

“I was married in October of 2000. My husband and I found out we were pregnant at Christmas time. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have a termination.

“The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time).

“To say the least, I was absolutely distraught with this news. I thought this was something that I did [...] because I stayed on the Paxil for selfish reasons.

“I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies.

“My husband and I are ready to try again to get pregnant in the next monthor two. I am so nervous. I don’t want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby, I want to know upfront. And I will somehow stop taking it for the time being.

“Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me. I just want to continue to have a normal life and have the child that I always wanted.

“Please contact me as soon as possible … Please don’t forget about me.”

The woman sent a second email, on 1 June 2001.

“This response is in regards to an e-mail that I had sent you previously. I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.

“I am in no way insinuating your product did this to my child. I love the product, and I don’t think I could have gotten through my panic attacks without the wonderful help of this miracle drug.

“I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her.

“Please, if you do not have this information, where is this information held? Does anyone do studies like this? Please, any information you may give me would be great. Thanks again for your help.”

The following GSK internal memo from June 2001 refers to her emails.

“Report 2001014040-1 describes the occurrence of a terminated pregnancy in a female of unknown age prescribed paroxetine (Paxil) for panic disorder.

“This report was received from the patient and has not been confirmed by a physician or other health care professional. Concurrent medications and medical conditions were not known.

“Four-and-a-half years ago, the patient started Paxil (dose unknown). Since taking Paxil, the patient noted she has been panic-free and has been able to go on with a normal life.

“Patient discovered she was pregnant in December 2000 while being treated with Paxil. However, she reported that at six months gestation the pregnancy had to be terminated because the fetus was diagnosed as having Truncus arteriosis.

“Her physician told her that the child would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered, if he was able to make it to that time.”

GSK emailed the following response to the woman on 6 June 2001.

“Thank you for your inquiry. We are attaching a copy of our current product information for Paxil. Please review the section on use during pregnancy.

“Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition.

“Because patient care is individualised, we encourage patients to direct questions about their medical condition and treatment to their physician.

“We believe that because your physician knows your medical history, he or she is best suited to answer your questions.

“Our drug information department is available to answer any questions your physician or pharmacist may have about our products. Your healthcare professional can call our drug information department …”

But an internal GSK internal document relating to the correspondence, headed “re-investigation of case number A0348482B”, dated 13 June 2001, states: “Relatedness assessment to medication – almost certain.”

In court, senior GSK officers in court said this apparent admission that the drug was responsible for the defects in the aborted baby was a mistake. They told the court somebody must have ticked the wrong box. GSK said it would appeal against today’s jury verdict.

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