The Food and Drugs Agency have a database of adverse events (AEs) reported for all the drugs in use. It is mainly reports from the USA but it is an international data base. It is far from being all the AEs experienced globally some are reported in similar databases in other countries. Many may not be reported at all.
So how many and what kind of events have been reported to FDA?
Taking a look at the adverse events received by the FDA for Ravulizumab for the most recent full month February 2026. Note these events did not occur in February 2026, but could have actually happened months before.
There were a total of 111 AE reports. Some may be just a list of concurrent events .
Of these 13 reports ( some times multiple events) related to aHUS patients. Myasthenia Gravis patients tend to report most AEs while using ravulizumab. aHUS tends to be around 10% of all reports.
Any way what is being reported for aHUS patients.
Sadly one is a death for two aHUS patients – a very serious adverse event. ( adverse events are categorised as serious or non serious)
At the other end, one AE Report said that there was no AE experienced.
In between there were a variety of events.
- One had a heart attack
- One had bone cancer
- One had meningitis and a TMA
- One had Hydrocephalus and Cerebral Thrombosis
- One had Hyperkeratosis – a skin problem
- One had Lupus ( SLE)
- One had Renal Impairment with cardiac dysfunction
- One multiple events including, Weight Increased; Cardiac Disorder; Renal Embolism ;Fat Tissue Increased ;Fatigue; Thrombosis; Diabetes Mellitus; Muscle Atrophy; Ischaemic Cardiomyopathy; Eye Disorder
- One had Hypersensitivity
- One had Malaise and Drug Ineffective
All these events happened while using ravulizumab but not all are due to the drug itself.
Some maybe may be described as ravulizumab AE side effects – meningitis, hypersensitivity to infusion. One may be due to some reason why ravulizumab may not work for some. Another could be a rare side effect. I t would be for Alexion to delve deeper and a rare cases it might even revise the patient leaflets’ list of side effects.
Is that a typical month, lets see what March produces?
Article No. 785
