Name:   CRD - Subject:   Uh Oh Carlson Date:   11/29/2020 9:31:08 AM

So for those of us who actually READ an article and not post a headline from CNN, here is the scoop:

Italics are from the actual paper.  

1.  It is already known that chloroquine and hydroxychloroquine, even used in approved doses for authorised indications, can cause a wide spectrum of psychiatric disorders. Psychotic disorders and suicidal behaviour are listed in the product information of some chloroquine or hydroxychloroquine-containing medicines as rare side effects or side effects occurring at an unknown frequency.

translation for Archie - Search any pharmaceutical data base or App, such as Epocrates, and these adverse reactions are listed for HC. Just like cardiac arrhythmias, nothing new.  

2.  EMA’s safety committee (PRAC) has recommended updating the product information for all chloroquine or hydroxychloroquine-containing medicines following a review of all available data that confirmed a link between the use of these medicines and the risk of psychiatric disorders and suicidal behaviour.

Translation for Archie - 6, that's right a mere 6, Spanish patients out of who knows how many total patients that receive HC, developed "Psychiatric Disorders" after receiving "higher than authorised doses" of HC.  This is what led to the initiation of the May 2020 review.  This is what reviewing "all available data" means in Europe?   God help the Europeans.

3. The review confirmed that psychiatric disorders have occurred and may sometimes be serious, both in patients with and without prior mental health problems.

Translation for Archie - So of the 6 patients that triggered this far reaching review, it may very well have been possible that they already had a pre-existing psychiatric condition that they were being treated for with these "higher than authorised doses" of HC.  What a shocker.

4. The PRAC recommends updating the product information for these medicines to provide better information to healthcare professionals and patients on the risk of suicidal behaviour and psychiatric disorders.

Translation for Archie - The PRAC review simply recommends highlighting the already existing adverse reactions sections on package inserts regarding psychiatric exacerbations a/w HC.

So bottom line, 6 Spanish patients who received HC at an unknown dose and frequency, for an unknown length of time, who may or may not have had a pre-existing psychiatric condition at the time, who may or may not have been receiving psychiatric treatment for said psychiatric condition, developed a well known serious adverse side effect of standard doses of HC and this had led to bold facing the package insert for professionals.  

Archie, if you question my summary here, please correct me.