My brother died on March 20th. He experienced a heart attack after taking his first dose of the antibiotic doxycyline on March 16th – a drug he was incorrectly prescribed – as he had no infectious illness. His respiratory symptoms were down to pulmonary oedema and a failing heart. Being treated for a chest infection and unaware of his heart problems he did not know he had suffered a heart attack. It was only through looking at what he had written to a friend (after his death) that it became clear he had a heart attack. He couldn’t stand up, began sweating, experienced a sudden drop in body temperature along with aching arms and chest pressure.
He did not know it but he was a seriously unwell man. He was left even more confused after reading the doxycycline Patient Information Leaflet. Believing his symptoms were side effects of a much needed drug he carried on taking the medication until he suffered a fatal heart attack four days later.
I completed a MHRA Yellow Card in good faith. The MHRA got back to me and informed me of one other fatality and a total of four other cardiac ADRs (adverse drug reactions) that had been reported. My brother seemed to be different from these other cases in that he was not taking another medication and had no other health conditions. The MHRA told me the case had been carefully considered. They said they were not concerned about the drug’s safety, offered condolences and that was that.
I didn’t know much about the Yellow Card Scheme at that juncture but I started to ask people I spoke with whether they had heard about it. Awareness of the scheme seemed abysmally poor. Even the practice manager of the GP surgery who had prescribed the medication for my brother had never heard of it – after 20 years of working in a GP surgery. I informed the MHRA about this lack of awareness as I found it quite alarming. Poor awareness means under reporting of ADRs.
As a complementary therapist I know many patients who inform their doctor about ADRs – but find their concerns are disregarded as side effects. They do not complete Yellow Cards if they don’t know about the scheme – and the medics certainly won’t be filling them in! These ADRs include cardiac reactions to antibiotics.
I did not look at the individual drug analysis profile for doxycycline at that point. I had other things to deal with and was overwhelmed with the bereavement, with the cause of death being misreported in the tabloids to get a Covid 19 story to link the death with the production closiure of the soap Hollyoaks – where my brother worked. When the MHRA wrote to my MP, Rt Hon Rachael Maskell, who raised concerns to them about the case, they informed her about this drug analysis profile so I looked it up. I hadn’t seen it on the website before – and the MHRA had not mentioned it to me.
There are 62 reported cardiac adverse drug reactions and four cardiac fatalities (including my brother).
The post mortem report did not corroborate that a heart attack had occurred on the same date that my brother had experienced one. The histological evidence was prioritised over the lived experience by the pathologist and coroner. I find this odd. Both are important but people seek help because of lived experience – not histology. Surely a Patient Information Leaflet needs to reflect the lived experiences of patients and offer advice and guidance in the light of these experiences? The pathologist also wrote in his report that he could find no evidence in the literature that doxycycline is associated with exacerbating or causing ischeamic heart disease. What about the 62 Cardiac ADRs including three other fatalities reported to the MHRA – didn’t they count? Why wasn’t the pathologist considering these ADRs? More to the point – why didn’t the pathologist and coroner complete Yellow Cards? Why only me? The coroner had all the details of the case including the misunderstanding caused by the Patient Information Leaflet. There was no reason for an inquest (as far as the coroner was concerned) – who decided not to communicate with me further – making me feel I was some sort of pesky annoyance as I sought to achieve learning from the case to prevent future deaths. I only wanted something good to come out of my brother’s tragic death to help others.
I wrote back to the MHRA to flag up that the scheme would be underestimating ADRs due to poor awareness and suggested the Patient Information Leaflet needed to explain much more clearly the symptoms of a heart attack and tell people to call 999 – or more would die like my brother.
The response I received does not inspire confidence in this government agency.
I am told in great detail about the efforts to promote awareness of the scheme – instead of giving consideration to what it might mean that awareness is poor – in terms of patient safety.
I am told the reason for the discrepancy between the number of fatalities I was informed about (one) and the number on the Drug Analysis Profile (three not including my brother) is because two were not considered relevant? Why? Because they had no pre-existing heart disease. I am at a loss to understand what difference this makes if they died after taking the drug. Am I missing something?
Perhaps most saddening of all – I am told there will be no changes to the Patient Information Leaflet in the light of my brother’s confusion that led to his death – evidently his death doesn’t matter.