https://link.springer.com/article/10.1007/s00101-012-1999-z I m posting here as local laws in my country requires any safety issue to not be public and since this is documented in reasearch under other drug names, my safety reports were denied escalation. So this is about a safety issue with Buccolam 10 mg, which is under-documented in psychiatry and the drug used mainly by caregivers of people with epilepsy without the relevant precautions. The legal issue is neither the package leaflet nor the Summary of Product Characteristics (SmPC) mentions it, thus making it an issue equivalent to the Depakine/Sodium valproate case. Anaesthetists know that the drug's active substance (midazolam) can, in rare cases, alter memories into memories of sexual assault. One dose of Buccolam roughly corresponds to the dose that can produce a false memory of sexual assault in the operating theatre (sodomy in men), and it is slightly higher in women because of the difference in body weight. The url is a review cited several times, published in a peer-reviewed Springer Nature journal. In Germany, the review recommends that patients should never be anaesthetised or sedated without qualified healthcare staff present as an independent witness or filmed. This matters because the risk of a prison sentence is particularly high when a memory of sexual assault is involved: innocence is particularly difficult to prove, and the use of midazolam is not proof that no sexual assault took place. There is also a case similar to mine involving another drug used for the same purpose: Jodin Froeber, in Wisconsin, who did not, however, make the connection. The Europpean Union Buccolam package leaflet and SmPC only mention hallucinations, but in psychiatry, where patients with epilepsy are concerned, people think of things like pink elephants, not of a legal risk, or of having to kill oneself or be killed in order to protect your familly who now dislike you. I acknowledge, however, that I do not have the means to survey psychiatrists to assess what proportion of them are aware of this: if the number is high, then this is medical school knowlwedge and the problem only concerns caregivers of people with epilepsy. Consequences: For the patient: post-traumatic stress. Suicidal thoughts, or even suicide. Breaking off relations with the family or the relative concerned, while ultimately being glad to have made that decision, in the sense that the false memory leads to a false or genuine realisation of how terrible such a person is in reality. For the accused: a sentence of decades in prison for sexual assault of a vulnerable person, and/or a vendetta, or even, in the most extreme cases, gjakmarrja. Since the latter cannot be stopped by the police or the courts, the only way to escape it remains to emigrate or to pay for a squad of round-the-clock bodyguards for each of the family members who need protecting. The problem is within countries under the EMA authority from the Europpean Union. The Canadian SmPC do mention the risk.   submitted by   /u/AbbreviationsGreen90 [link]   [comments]