PILs are meant to protect patients from harm, to provide us with information about ‘side effects’, adverse reactions of pharmaceutical drugs. The UK’s drug regulator has admitted they do not do so.
Pharmaceutical medicine works within the confines of a code of ethical conduct that (should) recognise the possible dangers of drugs and vaccines, and thereby seek to protect patients from harm.
One central concept is that if pharmaceutical medicine can cause serious patient harm, patients should at least be informed about that possibility, not least to enable them to make an ‘informed’ choice about whether or not to take the drugs/vaccines/treatment.
That is why we have Drug Regulatory bodies - to ensure that we are all informed about the potential dangers of pharmaceutical drugs and vaccines.
That is why drug companies are obliged to test their vaccines and drugs for both (i) safety and (ii) efficacy - and to put this information on PILs.
That is why doctors have a reporting system (Yellow Card system in UK) that obliges doctors to report any adverse drug effects suffered by their patients to the drug regulator.
And that is why all vaccines and drugs prescribed to patients are accompanied by a PIL, or Package Insert, to inform patients about the potential harm each drug are known to cause.
The problem is that (i) Drug Regulators are now controlled and staffed by people with close links to the Pharmaceutical industry, whose main concern seems to be the best interests of the industry rather than the safety of patients. Another problem is that (ii) Big Pharma companies are the main funders of the ‘medical science’, and have demonstrably corrupted the ‘science’ that is supposed to underlay conventional medicine. And further, (iii) most adverse drug reactions are not routinely fed to drug regulators, those that are reported are increasingly ignored, and so many adverse drug reactions do not make their way on to PILs'.
These long-standing ‘faults’ in drug regulation, all meant to protect patients from harm, have been discussed on this forum many times. But hitherto I have paid less attention to the inadequacies of PILs.
The medical journal, MIMS reported in October 2026 that the UK’s drug regulator, the MHRA, is to undertake a major review “to improve communication of key risks associated with antidepressants, including suicide and sexual dysfunction..…” The article says that this action follows a major review that recognised most patients are NOT being sufficiently warned about the adverse reactions to antidepressant drugs.
“The review came after patients and families raised concerns regarding the adequacy of existing PILs in communicating antidepressant risks”
What this means, in effect, is that antidepressant drugs, prescribed by thousands of doctors to millions of patients for over 70 years (antidepressant drugs were developed in the 1950’s) have not been accompanied by PILs that adequately warn about the risks of taking them! So, it says, doctors must now to impart this to their patients.
“Clinicians are advised to discuss the risks of suicidal thoughts and behaviours, and the potential for persistent sexual dysfunction with patients when starting or changing an antidepressant dose, or at their next review. They should also advise patients to seek urgent medical attention if they experience new or worsening suicidal thoughts, particularly early in treatment or following dose changes.”
After 70 years this is seriously belated advice! Both suicide and sexual dysfunction resulting from antidepressant use has been in PILs for decades! And these are just two serious side effects that have been known about antidepressant use for decades. The Drugs.com website, for instance, reports many more serious side effects, including drowsiness and fatigue, gastrointestinal problems, and weight gain and much more. So it should be asked:
How many depressed people have committed suicide (and self harm) not because of their depression but because of the drugs they were taking to ‘treat’ their depression?
How many people with problems during sexual activity, such as lack of libido, arousal, orgasm, pain, should now be blaming pharmaceutivcal drugs rather than personal inadequacy? (And perhaps the relationship between antidepressant drugs and gender dysphoria should be more closely investigated, something I have already written about, here.
Gastrointestinal problems and weight gain are also growing health problems. How many patients have these problems because they have been taking antidepressants, without realising that they are well-known adverse reaction? And how many patients now taking the new, much lauded weight-loss injection drugs are doing so as a result of the havoc that has been caused by taking another pharmaceutical drug?
Violence is another known ‘side effect’ of taking antidepressant drugs. This is also in conventional medical literature. The question is, to what extent has this serious social issue, that has increased enormously in recent years, the result of taking antidepressant drugs? Dare I say that social violence has grown “in line with the increased consumption of antidepressant drugs”? And that there are many other pharma drugs that are known to cause violence. I have read many cogent, well researched articles suggesting that most mass shootings in the USA were carried out by people with ‘mental health’ problems, and who were taking antidepressant and antipsychotic drugs. I have no evidence to suggest that this is any different in the UK!
All this indicates that PILs do not, and have not worked. It is not just about antidepressants and sexual dysfunction/suicide. Most patients, taking most drugs, remain oblivious to the possibility of drug harm. The information contained in PILs have just not reached patients.
So what measures are the MHRA bringing about, what are the “new safeguards to strengthen antidepressant safety information”? They are breathtakingly simple. But unfortunately there is no explanation about how they will be more “visible” to patients than they have been hitherto.
“A new boxed warning in the PILs aims to highlight information on suicidal thoughts and behaviours and signpost patients to sources of help. The term post SSRI sexual dysfunction (PSSD) is being added to the PILs of antidepressants associated with a risk of sexual dysfunction which may persist after treatment discontinuation, including certain SSRIs, SNRIs and tricyclic antidepressants.
“A new patient card, to be included in or on medication packaging, will reinforce key safety messages and help patients and carers understand how and when to seek further support. It will initially be available electronically, and may be given to the patient by dispensers as an interim measure ahead of cards becoming available. Hard copies are expected to be credit card-sized and easy to carry.”
Yes, but the crucial question is this. How will patients be any more likely to see these new methods of communication, especially if there is no-one who is going to draw their attention to them.
“An ancillary safety leaflet is being developed in collaboration with other healthcare system partners to provide more detailed information on the benefits and risks of antidepressants, as well as alternative treatment options. It is intended for use during the first consultation for new patients or at the next consultation for existing patients, and is expected to become available in 2027.
Yes, but will doctors avail themselves of the opportunity to do this during the first, or next consultation? They could/should do so now but rarely do!. So will they be any more likely to do so under this new jurisdiction?
Finally, MIMS quotes Dr Alison Cave, MHRA Chief Safety Officer, as saying that “these measures will help ensure patients, carers and healthcare professionals can have more informed conversations about the benefits and risks associated with antidepressant medicines, and better support people throughout their treatment’.
Unfortunately she does not say how this will happen! She fails to address the historical unwillingness of the Conventional Medical Establishment to inform patients about serious adverse drug reactions. From pharmaceutical companies, to medical science, to medical journals, to doctors and nurses, dismissive mantras, and throw away comments, are commonplace. “They are well tolerated” patients are routinely told. They are meant to reassure. They are meant to persuade patients to take the drugs. They are not honest!
I, for one, will certainly NOT be ‘tolerating’ any vaccine or drug.
And I patiently await the time when the Conventional Medical Establishment demonstrates that it is prepared to be honest and transparent with their patients about the serious adverse drug effects their medications can, and do cause.
