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Sunday, October 20, 2013

Are GSK Concerned About the Zofran Noise?




A week or so ago I was contacted by Tomisha LeClair who educated me on a GSK drug called Zofran.

Zofran (Ondansetron)  is a serotonin 5-HT3 receptor antagonist used mainly as an antiemetic (to treat nausea and vomiting), often following chemotherapy, it's also used to treat morning sickness in pregnant mothers, albeit off-label.

Tomisha LeClair, from Dorchester, Massachusetts, fell pregnant in 1999 and like many women developed  nausea and vomiting and was prescribed GlaxoSmithKline's Zofran.

At seven months gestation Tomisha was given an ultrasound and was told by doctors that her unborn daughter had a renal cyst; a fluid filled sac on one of her kidneys. The medical staff explained there are many children born with this complication and if necessary she could be treated with antibiotics upon birth.

Shortly after, Tomisha was referred to genetic counseling by the same staff to explore the medical backgrounds of herself and her daughter’s father. The counselling was trying to determine if either Tomisha or her husband had any family history of birth defects.

Tomisha was closely monitored with ultrasounds and weekly visits with her midwife who continued to prescribe Zofran to her during her last trimester of pregnancy.

In May, 2000 Tomisha gave birth to her daughter Ahjanee.

Tomisha takes up the story...

After giving birth to Ahjanee I knew something was amiss; the medical staff did not convey much information at that time. I waited six hours to see and hold her I was then told she had a genetic syndrome called Smith Lemli Opitz syndrome. The obstetrician’s explained children diagnosed with this syndrome do not live to age 10.
A few days into our stay at the hospital, some Dr.’s approached me for consent to test my daughter’s blood for the syndrome characteristics of smith Lemli Opitz to positively confirm diagnosis. This test as explained to me would indicate whether Ahjanee’s blood revealed an elevated de-cholesterol level common in children with this syndrome. Agreeing to the test several days later I was informed the testing indicated my daughter did not have this genetic syndrome. While visiting with my daughter during her stay at the (NICU) Newborn Intensive Care Unit, and speaking daily with medical staff for updates; a new genetic syndrome had come to the minds of the Dr.’s and so they suggested my daughter Ahjanee may have Schinzel-Gideon syndrome.                                                                                               
Again the medical staff requested permission to perform a test this time a full body bone scan to compare Ahjanee’s bony findings to that of children with this syndrome, again I complied.
After this syndrome was ruled out, my baby was finally discharged after staying eleven days in the NICU.
The geneticist’s at Children’s Hospital now proposed my daughter may be suffering from Pallister-Killian disease. This disease, Pallister-Killian caused children to have stunted dwarf-like growth, and poor circulation throughout their bodies. For the third time I agreed and consented to testing this time in the form of a brain-scan to examine my daughter’s brain size, make-up, structure, activity, and brain function. Though none of this testing was painful to Ahjanee it had a deep impact on my daily functioning due to the fact I was certain they would diagnose her with some untreatable disease or syndrome.
After three attempts to find a proper diagnosis for my daughter the genetic specialist’s told me “We are not sure what her condition is at this time, there is a strong likelihood that the problem is genetic and may take years to diagnose”. At this point, I began to do some research of my own to find out more about the medication I was prescribed throughout the pregnancy. After all, I had no genetic indicators in my family or the family of my daughter’s father. The fact that both he and I had other children without any genetic abnormalities I felt the Zofran was worth looking into. Discharged from the hospital after eleven days of the Newborn Intensive Care Unit, Ahjanee was given the diagnoses “multiple congenital anomalies”; meaning one born with many abnormalities.

In the latter part of 2000 I wrote to the (FDA) the Food and Drug Administration to complete a Med-Watch form reporting my daughter’s “abnormalities”. I initiated a (FOIA) a Freedom of Information Act request to the Food and Drug Administration inquiring about the adverse reactions reported by other patients who had also been prescribed this drug, to compare them to Ahjanee’s abnormalities. My suspicions were that the “wonder drug” had caused Ahjanee’s abnormality’s. Several weeks later I received a 20 page alphabetical list of all the reported adverse reactions reported by other patients, compiled into percentiles.
 

Skip forward to October 2007. Ahjanee, who at the time was just 7, had to undergo a dental surgical procedure to correct oral abnormalities. Just before the surgical procedure Tomisha met with Ahjanee's physician and expressed her concerns regarding the medication they may use on her daughter  to prevent nausea and vomiting. She expressed that she did not want her daughter to be given Zofran as she believed that it was the Zofran that she was prescribed during her pregnancy that caused Ahjanee's abnormalities in the first place.

Nightmare Comes True

Ahjanee underwent the surgery and all, it appeared, went well. Whilst in the waiting room Tomisha was greeted by the surgical nurse who informed her, “The surgery is over, Ahjanee is doing well, and we gave her Zofran to prevent nausea.” 

Two months after Ahjanee’s oral procedure at Children’s Hospital Boston, Tomisha received a letter of apology from the anesthesiologist which mentioned the mishap and some suggestions on why it may have occurred, by pointing fingers at someone on his team.

As a mother Tomisha has extensively researched Glaxo's Zofran. She has even been contacted by other mother's who have also given birth to children with abnormalities, all of whom were taken Zofran during their pregnancy.

The Role of GSK's Global Clinical Safety and Pharmacovigilance.

Tomisha has kindly showed me the emails she received from Shannon Anderson, clinical safety specialist for GlaxoSmithKline’s (GSK) Global Clinical Safety and Pharmacovigilance Division.

Tomisha has been quite vocal regarding the dangers of taking Zofran during pregnancy, something that Glaxo picked up on:

Dear Ms. LeClair, 
This email is to follow-up on your previous report regarding Zofran (ondansetron hydrochloride). 
Your experience was brought to GSK’s attention after you discussed the use of the product on the internet. When we hear about an adverse experience with one of our products, we request permission to collect medical records so that we may learn as much as possible about the circumstances of the event. 
This information allows us to continually assess the safety of our products.
 
While you are under no obligation to do so, if you do choose to provide GSK with an authorization for the collection of medical records, GSK will evaluate the records and keep the information confidential, but we would provide a report based on the records to the United States Food and Drug Administration, in accordance with federal regulations.
 
If you choose to provide GSK with an authorization for the collection of medical records, please reply to this email or call us with your complete mailing address, so that we may mail you an “Authorization To Contact Physician” form to be completed and returned to us in an enclosed postage-paid envelope.
 
Thank you for your assistance. If you have further questions, please contact us toll-free at 1-888-825-5249 during our business hours, Monday through Friday, 8:30 a.m. to 5:00 p.m. Eastern Time.

Sincerely,
Global Clinical Safety and Pharmacovigilance

GSK were refering to the Facebook Page Tomisha had set up to create awareness about Zofran, namely MA'Z (Mother's Against Zofran Birth Defects)

The Facebook community is an excellent way to make connections, it's also a great way to spread a message and to seek other people who may have endured medical mishaps or injury as a result of being prescribed prescription medication.

In an email Tomisha told me:

The "adverse reaction" list from the FDA is 26 pages long and contains every "abnormality/anomaly" my daughter and many of the other children have.The Center for Drug Evaluation and Research (CDER)  Report is alarming to say the least! If I had to be scientifically specific regarding what Zofran has caused within the children, I would say that Zofran prescription during pregnancy causes clusters of symptoms such as cranial abnormalities; my daughter has microcephaly [Fig 1], and another child hascutis cutis aplasia (characterized by the absence of a portion of skin in a localized or widespread area at birth), and there is one more cranial/skull abnormality that I can't recall by name. One child has Ebstein anomaly (a congenital abnormality that is present from birth and affects flaps that make up the tricuspid heart valve) and another has Hirschsprung syndrome (missing nerve cells in the muscles of part or all of the baby's colon) and another has clubfoot.(Fig 2)

Zofran, appears to mutate gene's of the children and many are born; premature, low birth-weight, failure to thrive, and learning delays. A few of the children have suffered limb abnormalities such as one child has a missing hand, the arm formed properly up to the hand, where the mother explains circulates no blood flow, another child, a boy, whose mother reports he did not form bone in his leg, and one other child who is missing some portions of her scalp. At least five or more children have suffered cardiac abnormalities such as arterial stenosis, murmur's, and more. Groups of the children have been diagnosed with varying levels of hearing loss. Some of the children were born with genital abnormalities, one woman reported her son is 3 and has undergone 24 surgeries thus far, and will need monthly hospital visits throughout his life! Another woman has a daughter whose organs were developed in the wrong locations of the body such as her kidney's, and liver; this same young lady also does not have a spleen! She was born without one, and therefore takes antibiotics daily.


Fig 1 - Microcephaly


Fig 2 - Clubfoot

I'm left wondering if Glaxo monitor all patient advocacy groups and whether or not they contact people who claim to have been harmed by their drugs. The Paxil Protest Petition amassed over 10,000 signatures. Are we to believe that GSK contacted every one of these individuals too?

Zofran, just like Paxil, certainly seems to be linked to birth defects and I have to commend Tomisha for creating such a great awareness about yet another drug manufactured by GlaxoSmithKline.

Glaxo will, of course, claim that Zofran is not meant to be given during pregnancy. Question is, did Glaxo reps promote it's use for women who were pregnant? Glaxo will also no doubt point to the many studies that have concluded that Zofran does not cause harm to the fetus.

One has to remember that they said all this when they defended their corner in the Kilker v GSK birth defect case, a case which they lost.

One thing is for sure, Tomisha LeClair seems to have ruffled the feathers of GSK.


Bob Fiddaman.


MA'Z (Mother's Against Zofran Birth Defects


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