Lack of information about side effects
Avoidable birth defects
At the age of 28, Jennifer developed pain in her elbows, knees and feet.
Her feet were swollen, she had difficulty walking and sitting, even doing up her bra was difficult. At first she thought the pain was related to her physical activity. Jennifer was a keen runner and regularly competed in marathons.
Jennifer went to see her General Practitioner. He ordered a blood test which indicated she might had rheumatoid arthritis.
Her Doctor referred her to a private rheumatology specialist in Melbourne.
Jennifer got in to see the specialist after six weeks. He confirmed the diagnosis of rheumatoid arthritis and started her on two medications, cortisone and methotrexate.
The specialist did not discuss any side effects of these medications. There was no issues raised about Jennifer being able to have children on the medication. Jennifer was childless at this stage. She had been married for several years.
The prescribed treatment controlled Jennifer’s symptoms. Walking and every day living became much easier. There were no obvious side effects from the two medications.
There was no education given to Jennifer about the potential side effects of the medications she was taking.
Jennifer had private health insurance. She presumed that this would give her a better standard of medical care.
Four years after starting treatment for rheumatoid arthritis, Jennifer and her husband went to see the specialist to specifically ask him about the effect her medication might have on her child bearing abilities.
Jennifer and her husband wanted to start a family. She was thirty two by this stage. The specialist advised her to stay on the medication until she become pregnant.
The year was 1999 and the internet was not widely available.
Jennifer had a home computer. Although her husband worked in telecommunications, the thought of looking up medications on the internet did not occur to either of them. Jennifer and her husband felt very confident the specialist had given her the correct information.
“Once you fall pregnant come back and see me” her specialist advised.
Jennifer fell pregnant almost straight away. At approximately six weeks into her pregnancy she went back to see her specialist, to tell him she was pregnant. He took her off the methotrexate but he did not discuss any effect the drug might have already had on her unborn child.
Her specialist simply said that she would not need the drug during pregnancy, because the changes in hormones would cause her disease to go into remission.
Jennifer’s pregnancy was unremarkable, in fact she felt fantastic throughout it. She breast fed her son for two months, then stopped as the the pain in her joints returned. Jennifer returned to the specialist who put her back on to methotrexate.
Problems with Jennifer’s child occurred within the first few months. He wasn’t reaching his childhood milestones. Jennifer felt there was something wrong, but didn’t’ know what.
At seven months of age the boy had his first febrile convulsion. He was admitted to hospital. The hospital doctor told Jennifer that the child had low muscle tone. He wanted to test Jennifer’s child for a possible genetic disability. Jennifer was then referred to a paediatric neurologist. Her son was now having regular febrile convulsions.
The test results came back several months later and Jennifer was told that her child had a chromosomal and neurological defect. The doctor said this can be genetic but he didn’t think either Jennifer or her husband had this condition. By this time her boy was 10 months old.
The neurologist was blunt.
“I suggest you do not work at all, because the boy will take up a lot of your time.”
The neurologist also told Jennifer that her boy may not be walking or talking by the age of three.
Jennifer was shocked and started crying.
After the formal diagnosis, Jennifer told her family.
Her sister in law lived in New Zealand and worked in a government health department. She looked up the medications that Jennifer had been taking for a number of years.
It was revealed that methotrexate had a number of well established side effects on an unborn foetus. The drug was not given to young women of child bearing age in other countries. Jennifer’s sister in law sent over a large amount of written material.
Jennifer and her husband read it all. They were shattered.
Jennifer went back to the specialist who had originally put her on methotrexate. She showed him all written material proving that methotrexate was a dangerous drug for woman who were pregnant band even those that were trying to fall pregnant. The specialist was surprised that Jennifer had put so much effort into her research. He denied knowledge about the side effects of the drug he had prescribed her.
Jennifer had completely lost faith in this Doctor and went to see another rheumatologist.
Jennifer explained how she had been on methotrexate during the first trimester of her pregnancy, believing it would not damage the child. She also explained the diagnosis of her child as being severely disabled. The new specialist advised her that she should not have been on methotrexate for three to six months prior to conception.
He told her it was ‘unfortunate’ that she had received incorrect advice.
A physiotherapist started coming to the house by the time the boy was one years old. This was funded by the government but was only for a short duration.
The family was finally told that it would be good if the boy went to an early intervention centre. He started going once a week from 9am until 3pm.
The diagnosis given was ‘developmental delay’. The boy continued going to the early intervention centre until he was two and a half years of age.
Jennifer found out by a chance conversation with another parent, that she could get more help at a special developmental school. She then took her son to this school three full days a week. This cost her a small amount as it was government funded. The service included pick up and drop off by special bus. The school also has a hydrotherapy pool and they provide day excursions into the community.
By this time, Jennifer also realised that her entire life was going to revolve around caring for a disabled child.
She approached a law firm about legal action. The law firm investigated her case for a year, but could not prove ‘beyond doubt’ that the methotrexate had caused her son’s mental and physical problems.
When her boy was four, Jennifer received advice from a friend, who’s husband was a lawyer, that she should still try to receive compensation. She then approached another law firm.
This law firm agreed to take on the case and papers were served on the rheumatologist before Jennifer’s son turned five. They took five years to investigate.
Finally the law firm told Jennifer “you can go to court, with a less than fifty percent chance of winning.” The cost of going to court would have been hundreds of thousands of dollars. Jennifer and her husband did not have that kind of money and were advised to settle out of court.
After five years of struggling with legal action, Jennifer was finally given less than $100,000 in compensation to help her care for her severely disabled son for the rest of his life.
Jennifer’s marriage had become dominated by the disabled child and fighting legal action. Her husband sought a divorce.
Fourteen years later Jennifer works only five teen hours a week. Her son lives at home. Jennifer is his main carer. He needs help with eating, feeding, bathing, toileting and dressing. He has no speech and can only walk short distances. He has the mental age of a 2 year old.
Jennifer receives fourteen hours a month of home respite run by the government. Her son goes into a respite house once or twice a week for the night to give her a break. Jennifer’s income consists of a low wage, a careers allowance and her child support. She has saved hard over the years and has paid off the house. She never remarried and has had no further children.
Jennifer has devoted her life to caring for her son.
“He is my responsibility” she says simply.
Jennifer says this experience has changed her whole opinion of the health profession. She says that she does not trust doctors any more. She is disappointed that her specialist was so lacking in medical knowledge, that he prescribed a pregnant woman a drug which can cause foetal deformities. She cannot believe people like this can continue to practice medicine without any ramifications.
Jennifer is now on a new rheumatoid arthritis drug called Enbrel. She is other wise physically well. She goes to a social group once a fortnight. She has not seen her husband for over a year. He no longer has contact with her son. He has remarried and has two normal children with his wife.
Jennifer wishes to share this story with other people, in the hope that they are aware of medical errors that can occur and will hopefully never happen to them.
Although it has been a difficult journey, Jennifer is very happy knowing that her son has a good quality of life and is generally happy. His favourite things are water, music, toys that play music, have lights and sounds, food, books and trampoline.
With the compensation payment, Jennifer decided to spend most of it putting in a small built-in pool that can be used throughout the whole year. Her son uses it every day for a good couple of hours. Her son’s well being is the most important thing to Jennifer.
Mother to Baby – Methotrexate and pregnancy. Medications and more during pregnancy, ask the experts
Multiple anomalies in a fetus exposed to low-dose methotrexate in the first trimester. Pub med. 2002. Obstet Gynecol. 2002 Apr;99(4):599-602. Nguyen C1, Duhl AJ, Escallon CS, Blakemore KJ.
Maternal exposure to methotrexate and birth defects: a population-based study.
Dawson AL1, Riehle-Colarusso T, Reefhuis J, Arena JF; National Birth Defects Prevention Study.
The effects of methotrexate on pregnancy, fertility and lactation.
M.E. Lloyd, M. Carr, P. Mcelhatton, G.M. Hall, R.A. Hughes
DOI: http://dx.doi.org/10.1093/qjmed/92.10.551 551-563 First published online: 1 October 1999
Rheumatoid Arthritis Drug Methotrexate Could Harm Unborn Babies.
By Mollie Bloudoff-Indelicato, Everyday Health Staff Writer
Methotrexate Pregnancy and Breastfeeding Warnings. Drugs.com. Know more, be sure
Methotrexate is also known as: Folex PFS, Methotrexate LPF Sodium, Otrexup, Rasuvo, Rheumatrex Dose Pack, TrexallMethotrexate (MTX) has been assigned to pregnancy category X by the FDA. MTX can cause fetal death or teratogenic effects when administered to a pregnant woman. Women of childbearing potential should not be started on MTX until pregnancy is excluded and should be fully counseled on the serious risk to the fetus should they become pregnant during treatment.
Methotrexate – Wikipedia