On Thursday, May 31, 2001, a woman whose name is known only to GlaxoSmithKline emailed the company:
I was absolutely distraught
“My name is… 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, was 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 month or 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, Thank you.”
We are attaching a copy of our product information leaflet
GSK responded on Thursday May 31st:
“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 individualized, 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 at 1-888…”.
[As of 2001 the label for Paxil made no mention of the number of reports of congenital abnormalities associated with Paxil. Company policy at the time was not to tell doctors or patients or pharmacists how many reports of congenital abnormalities had been reported with Paxil usage].
I do not want to put my unborn child through anything that would hurt him/her
On Friday, June 1, 2001, the unknown woman wrote again:
“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.”
On June 13, 2001, an internal division within GSK monitoring adverse event reports looked at this congenital abnormality and made a judgment about the link to medication. Their judgment was that it was “almost certain”.
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