— There’s reassuring news for pregnant women miserable with morning sickness: A very large study in Denmark finds no evidence that using a popular anti-nausea drug will harm their babies.

Says Dr. Iffath Hoskins, a high-risk pregnancy specialist at NYU Langone Medical Center and a spokeswoman for the American College of Obstetricians and Gynecologists……”It’s effective and it’s safe”.  “Nobody is giving you a gold star for suffering through this.”   CLICK HERE to read the rest of this marketing campaign article.

It’s articles like this one, headlining in news feeds no less than 44 times (at which point I stopped counting) that could lead a mother to believe that Zofran was safe.  That a drug prescribed by a professional, backed up by studies completed by specialists,  recorded in scholarly medical journals, would have no adverse effects on the baby growing inside her.

A young woman recently contacted me asking if I could help her.  She wants to (and is doing so herself) raise awareness regarding the adverse effects her baby suffered due to taking Zofran, prescribed for nausea, while pregnant.  Hmmm…. sounds familiar – Thalidomide.

She said, ” I think you posting on your blog would offer more exposure and maybe even identify more victims in Canada. I began this journey over 13 years ago, initially believing I was the only one!  My, my, my, how wrong I was”.

This unwitting mistake of mothers trusting their caretakers in believing  Zofran was safe is nothing short of an irresponsible and immoral  marketing campaign dreamed up by the pharmaceutical giant  GlaxoSmithKline.  Their purpose?  Money.

Her name is Tomisha LeClair and here is her story:

Tomisha and her daughter Ahjanee.

In 1999, I worked through a temporary agency at Ophthalmic Consultants of Boston processing Blue Cross and Blue Shield insurance claims for the eye laser surgery center. Shortly after my hire there I became aware of my pregnancy with my daughter Ahjanee. Often times at work I became sick and tried desperately to maintain my illness as much as humanly possible. To maximize my chances of keeping my job during my pregnancy I was evaluated at the hospital and soon after I was prescribed a medication for severe nausea and vomiting.

During the same hospital visit I inquired immediately about the drug I had been prescribed and it’s safety and effectiveness. At the time of my first pregnancy with my first born, my son, this medication had not been used. When pregnant with my son in 1991, I also became dangerously ill I lost weight, diagnosed as anemic, and remained sickly throughout the pregnancy until the last trimester when I continued to struggle with morning sickness though my symptoms were never limited to mornings. At the end of the pregnancy with my son I began gaining weight and experienced less hospitalizations, and medical interventions.

Having suffered during my first pregnancy I felt a sense of relief when prescribed what was referred to as “the new wonder-drug”, Zofran and relied on its ability to safely combat the nausea. The nurses explained while administering Zofran to me intravenously.  “All the midwives were taking this medication” because it showed remarkable treatment for severe hyperemesis gravidarium (literally means “excessive vomiting in pregnancy”).

While taking the Zofran pregnant with my daughter I rarely had sickness though I had still not gained a significant amount of weight and so I was told to continue taking medication as prescribed to minimize or eliminate altogether the morning sickness symptoms. As time elapsed I visited with my midwife and continued taking the medication as prescribed to reduce the symptoms. At seven months gestation I was given an ultrasound which doctors at the hospital conveyed to imply my 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.

It was at that juncture I was referred to genetic counseling by the same staff to explore the medical backgrounds of myself and my daughter’s father. After attending the genetic counseling session I was no closer to having answers than before I had arrived. The counselor asked many questions and explored the possibility of genetic factors which we would need to identify now, I explained that my daughter’s birth father and I both had other children though not together, still we had not uncovered anything vital and so I was closely monitored with ultrasounds and weekly visits with my midwife who continued to prescribe Zofran to me during my last trimester of pregnancy.

In May, 2000 I gave birth to my daughter Ahjanee who will turn 14 at the end of May. My labor slowly progressed because it was induced due to decreased fluid; revealed earlier that day by ultrasound after I had arrived to the labor and delivery department three weeks prior to my due date.  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 diagnosis”.

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 cause 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. Stunned by the findings of the adverse reactions reported list which included “every abnormality” that Ahjanee suffered from and was diagnosed with and numerous others.

One month after receiving the FOIA request I visited with the Midwife who prescribed this drug to me during my pregnancy. As we sat in her office I explained to her what my research indicated, I relayed my suspicions and the FDA report. It was then that my former Midwife confided that she had also taken the same drug during her pregnancy and had recently given birth to a son. I then inquired about the size, health, and birth gestation of her son. I suggested without knowing for certain based on my research and the FDA report her son was most likely born premature, low birth weight, with failure to thrive, and so I asked just that. When the Midwife confirmed my suspicions I pled with her to do some research of her own and in the meantime to stop prescribing the medication especially during pregnancy. The Midwife extended what appeared to be an offer of help to me and my daughter though even today I am still uncertain of just what she had in mind.

During further research I found that Zofran was originally only prescribed to chemotherapy patients suffering from nausea and vomiting due to chemotherapy radiation treatments.  I noticed that somehow the drug had been classified as a Class B drug which means it is equal or as safe as Tylenol use during pregnancy. I concluded the drug manufacturer Glaxo Smith Kline had legally protected their own interests by placing a “strong caution in pregnancy” label on Zofran inserts although the same drug manufacturer is aware of the off-label uses for the medication they do nothing to prevent it from being prescribed to the pregnant.

Note:  Not only did GSK protect their interests by placing a “strong caution in pregnancy”  they actively promoted Zofran to pregnant women for morning sickness.  See below (click for Zofran Timeline):

July 2, 2012:  The U.S. Department of Justice issued a press release (pdf) stating that GlaxoSmithKline would pay a $3 billion settlement after pleading guilty to, among other claims:

• promoting Zofran for off-label uses such as morning sickness treatment (since the FDA only approved the drug for chemotherapy-related and post-operative nausea); and
• paying doctors to prescribe the drug.

Tomisha  resides in Massachusetts and  actively works to warn other pregnant women of the dangers of Zofran.  She is also working on a bill called “Ahjanee’s Law”.  If and when enacted, this bill will require medical professionals to warn patients about side effects  of any medication prescribed during pregnancy prior to its prescription.  She can be found on facebook at MA’Z (Mother’s Against Zofran Birth Defects).

She  continues collecting signature’s for Ahjanee’s Law.

If you or anyone you know  took Zofran while pregnant (in Canada only)  please contact me.  A journalist has asked if I could find Canadian women who took ondansetron/Zofran to treat morning sickness/hyperemesis gravidarum.  He is researching/analyzing adverse reaction data relating to Health Canada’s transparency and accountability.