Spain’s AEMPS clarifies position on hydroxychloroquine, echoing statements of EMA and Lancet

Hogan Lovells

Hogan Lovells

The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) stated that it will not take, for the time being, any regulatory action to temporarily suspend or halt the recruitment of patients for clinical trials to evaluate the efficacy of hydroxychloroquine. In addition, patients who are already taking hydroxychloroquine in or out of clinical trials for COVID-19, as well as patients on chronic treatment with these medicinal products, should continue to take them.

Following the European Medicines Agency’s (EMA) press release recalling the risks of hydroxychloroquine and chloroquine – followed, as well, by the publication of a retrospective analysis published by the medical journal "The Lancet" – the AEMPS, in dialogue with clinical trial sponsors and scientific societies, has decided not to suspend or halt recruitment. Clinical trials enable the generation of evidence that is increasingly necessary within the current context. Moreover, the AEMPS recalls that patients enrolled in these trials are highly controlled, so this decision does not affect their integrity nor harm the quality of their care in order to overcome the disease. At present, there are 16 authorized clinical trials in 107 hospitals throughout Spain that include hydroxychloroquine, 10 of which are currently recruiting patients.

Regarding suspected side effects related to the use of hydroxychloroquine in COVID-19 patients, the data available as of today, according to the AEMPS, do not allow the identification of side effects additional to those identified in the summary of product characteristics (SmPC). Health care professionals, however, have been recommended to be extremely cautious and vigilant regarding the possible appearance of changes in the behavior of patients treated with chloroquine or hydroxychloroquine by COVID-19, warning patients and their families to consult their doctor at any sign that suggests a change in the patient's behavior.

The AEMPS will monitor all information as it becomes available. An interim safety analysis has been requested from clinical trial sponsors. In the absence of additional risks, it will not take any further regulatory action to suspend or temporarily halt the recruitment of patients into clinical trials to evaluate the efficacy of hydroxychloroquine. Patients who are already taking hydroxychloroquine in or out of clinical trials for COVID-19, as well as patients on chronic treatment with these medications, should continue to take them and, in any event, maintain their usual follow-ups with their physicians.

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