Adverse Reaction to Pharmaceuticals

national | consumer issues | news report Saturday July 01, 2006 17:33 by Kathy Sinnott

New committe established to investigate adverse reactions to pharmaceuticals

I had several long, worried nights with one of my babies. She was having difficulty breathing. No temperature, runny nose, cranky upset crying…nothing I could take her to the A&E with. There was just a subtle change in her that gave me an instinctive and terrifying sense that she was forgetting to breathe.

The first two times this happened I rang the midwife who had delivered her. I told her of my concern and also my dilemma. I felt my baby was in trouble. Yet I was fairly certain that my foreboding could not be taken seriously by a busy A&E doctor even if he or she wanted or had the time to take it seriously. The reaction would be, “Mrs. Sinnott just what do you think is wrong with your fine healthy daughter? Please take her home to bed and come back when she has at least one observable symptom.”

The midwife thankfully did take my concern very seriously. She knew that I was not a rookie but a mother well used to babies. She advised me to put a stack of pillows behind me and stay awake with my baby sleeping on my stomach and chest. She said that my breathing would help to prompt her breathing. If I felt the situation worsen, she advised that I go to the hospital and insist on being taken seriously.

These were long nights and all of them followed the same pattern: I would have a real sense that she was having problems breathing for no identifiable reason, an infant version of sleep apnea. In every case and I think there were 4 such nights, the situation ended abruptly about 3 or 4 a m when she seemed to return to normal. I could not describe the difference but it was real, so real that after another hour, I would be able to lay her on the mattress in full confidence and grab a few hours of sleep before morning and our usual family busyness began.

Was it my imagination? Was it a weakness in my daughter?

I remember that on the phone calls to the midwife, I told her, in answer to her questions, that my baby had been to the GPs few days before. She had not been sick but was attending for her checkups, which she passed with honours, and to be immunized. I often wonder if I had been less experienced a mother or if the midwife had told me I was imagining things and to get some sleep would I have lost my daughter to cot death.

It was some time later that I read about a pattern of breathing irregularities in young infants that fit my experience with my baby. Two studies described the pattern but did not explore causes. Another suggested a possible temporal connection with the pharmaceutical my daughter had received at her visits to the doctor and recommended further investigation.

There is so much we don’t know. What we do know is that pharmaceuticals do great good for many people but for some people at some times under some conditions even the best of drugs can do harm. The harm they do ranges from minor and temporary to harm that is permanent, disabling and even fatal. This help and harm relationship is called a Risk –Benefit Ratio and it’s a ratio none of us wants to be on the wrong side of.

But people do wind up on the wrong side and for them it is often the beginning of years of struggle. I think of a young woman whose acne medication has made her loose all her body hair. Though she stopped the medication when she realised the connection, she has not to date been able to reverse the damage. For her the baldness is only part of the problem, she must also endure the disbelief of the medical community and the refusal to take responsibility by the pharmaceutical company, even though her investigation has uncovered the fact that hair loss is a recognised adverse reaction of the particular drug, a reaction she was not informed of when she went on the medication.

This woman feels that had she known she could loose her hair, she would have found some other treatment for her acne. Sometimes we have a very serious condition and must take the risk of side affects from the needed prescribed drug, but we should still be warned of them, even if only so that we can report and deal with side effects more swiftly and appropriately.

In my experience, doctors do not generally like to discuss what can go wrong with the treatments they prescribe. There are probably valid arguments for and against reading out the list of contraindications, special precautions and adverse reactions from the MIMs. Maybe ignorance is bliss and not knowing helps the positive effect of the drug treatment. But when things go wrong not realising that it could be an adverse reaction to a drug often worsens the reaction especially when a patient keep taking it or even increases the doses.

On the Hope Project helpline I have heard many stories of side effects of pharmaceuticals. In my capacity as a member of the Health Working Group of the European Parliamentary Committee on Environment, Public Health and Food Safety, I have been approached by several organisations of people who are trying to highlight their plight as victims of prescribed pharmaceutical drugs. They are not anti medicines. In fact many must rely on medicines to deal with the damage from the offending one. But they are adamant that a naïve attitude to pharmaceuticals on the part of the public, a defensive one on the part of the medical profession and a less than helpful attitude in the face of an adverse event with a product on the part of the pharmaceutical companies is not good science or real justice.

The Joint Oireachtas Committee on Health and Children has set up a sub committee to investigate adverse side effects to pharmaceutical products. Thank goodness, such an investigation is long overdue. If you have anything to contribute, please write to them very soon.
Submissions to:
The Clerk of Joint Committee on Health and Children, Leinster House, Kildare Street, Dublin 2 or gina.long@oireachtas.ie