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While the US and the world is convulsed by COVID-19, a dramatic admission has been made by the US Food and Drugs Administration about dangerous benzodiazepine drugs, acknowledging patients have suffered severe withdrawal side effects that have “lasted from weeks to years.”

Their study reports that patients can be made “physically dependent” after taking benzodiazepines for as little as “several days.”

They have also said stopping benzodiazepines abruptly or reducing the dosage too quickly can cause severe withdrawal reactions “including seizures which can be life threatening.” Their study reports that patients can be made “physically dependent” after taking benzodiazepines for as little as “several days.”

Patients Campaign for Change

The FDA has not produced a report on the hundreds of thousands of complaints that have been made to them about benzodiazepines, but just 104 “focused case series,” in the FDA’s own Adverse Event Reporting System (FAERS) to which citizens can make a complaint about prescribed drugs. Benzodiazepine Information Coalition (BIC) almost certainly had an input to this FDA awakened awareness of the dangers of BZs through its campaign since 2017 to get those injured by the drugs to report their cases to the FDA’s MedWatch, with guidance on their site to demonstrate how to make a complaint, and assurance of its confidentiality.

Credit: © Jhvephotos | Dreamstime.com

This campaign in the US was also recommended to patient support groups around the world using W-BAD, World Benzodiazepine Awareness Day website, and direct approaches to other groups, like BenzoBuddies. This apparent success in the US informing realism within the FDA about how huge numbers of patients taking benzodiazepines as prescribed have had their lives destroyed, will make an international follow-up with patients informing their governments and their health agencies directly about this medical disaster more urgent and important.

The FDA’s hard-hitting statement says: “Physical dependence can occur when benzodiazepines are taken steadily for several days to weeks, even as prescribed. Stopping them abruptly or reducing the dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening.”

The statement continues: “The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately.”

The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately.

This is an historic and welcome U-turn by the FDA. Up till now they had been rejecting these injuries and dangers. It more resembles the golden age of the FDA when they refused to license Thalidomide in the sixties and saved the US from the terrible widespread birth deformities caused the drug. Benzodiazepines arrived in the late 1950s. The FDA are going to require a new box warning of the dangers on the drugs.

The FDA was first formally asked a decade ago to accept these real dangers of the drugs in a US Citizens’ Petition in 2010 signed by thousands of those injured by prescribed benzodiazepines, as well as concerned professionals, led by the late Professor Heather Ashton, a renowned world expert who died last year.

The Petition called for a black box warning – there was none – on the packaging of benzodiazepines. But that, and the suggested changes in the information leaflet, were ruled out in a breathtakingly complete denial and refusal of the entire Citizens’ Petition in 2015. Then, in 2017 the FDA rowed back, but very narrowly, conceding a request from just two doctors for a box warning – but only saying not to take benzodiazepines with opioids.

The Reports

It’s worth putting in context the FDA use of 104 FAERS cases to decide their new approach to benzodiazepines. Up to 2018 there had been 300,000 cases of reported complaints to FAERS about benzodiazepines and the so-called Z drugs (mainly sleeping pills, not strictly classified as benzodiazepines, but which have the same actions). That number of complaints outstripped opioids until that year.

Up to 2018 there had been 300,000 cases of reported complaints to FAERS about benzodiazepines and the so-called Z drugs. That number of complaints outstripped opioids until that year.

“Approximately 80% of the FAERS cases described benzodiazepine withdrawal, including CNS effects (e.g., insomnia, increased anxiety or panic attacks, memory impairment, depression), cardiovascular effects (e.g., heart rate or rhythm fluctuations), and gastrointestinal effects (e.g., abdominal pain, nausea, diarrhea). These cases reported a wide range of time to dependence, with some describing the onset as early as days to weeks after the start of a benzodiazepine. Similarly, there were variations in the duration of the withdrawal symptoms that lasted from weeks to years,” the FDA says.

“While this is a small subset of FAERS cases received for benzodiazepines as a whole, we selected a focused case series to identify the most descriptive reports of dependence or withdrawal. Most patients reported that dependence and subsequent withdrawal symptoms developed even when the benzodiazepine (clonazepam, alprazolam, lorazepam, diazepam, triazolam, or oxazepam) was prescribed for therapeutic use.”

Most patients reported that side effect injuries happened when they were taking therapeutic doses of prescribed benzodiazepines, and they suffered “withdrawal symptoms that lasted from weeks to years.”

This is very clear. Most patients reported that side effect injuries happened when they were taking therapeutic doses of prescribed benzodiazepines, and they suffered “withdrawal symptoms that lasted from weeks to years.” The FDA acknowledges that some patients suffer injury indefinitely after stopping the use of these drugs. Unfortunately for an uncounted multitude made severely ill by these drugs, this protracted injury after ceasing benzodiazepines was publicly revealed in medical studies by two leading international experts on the drugs, Professors Heather Ashton and Malcolm Lader, during the 1980s. However, their research was ignored by governments, the industry and the medical profession. In fact, it was frequently dismissed by medics, who told patients it was “all in their heads,” or the emergence of pre-existing conditions, anything but admit it was the benzodiazepine.

Too Little, Too Late

In my documentary launched in 2016, The Benzodiazepine Medical Disaster long term injury and illness caused by the drugs was a major theme. Professors Ashton and Lader spoke in the documentary about their decades old discovery of long-term injury caused by these widely prescribed drugs, the risks of severe withdrawal illness and life-threatening seizures. Both described the prescription misuse of the drugs as a “medical disaster.” Thankfully the video stands as a record of their great work since both have died in the past year. It has been voluntarily translated and then subtitled in Japanese, French and Spanish and English at the request of many whose languages are not widely spoken.

The late Professor Lader said he had spent forty years trying to convince the medical profession that exactly this was happening – people were being injured on prescribed therapeutic doses of benzodiazepines, and additionally, they were not escalating the dosage.

It is also worth noting that, ironically, the danger of seizures from abruptly ceasing the drugs was first reported in the US in a 1961 study carried out by Dr. Leo Hollister on the first Roche benzodiazepine, Librium, even before Valium was launched.

The FDA laments the lack of epidemiological research on the drugs, launched in the late fifties and sixties, when proper testing did not exist. It begs the question as to why the FDA does not commission detailed research into the huge number of complaints that it has available to it; or why it does not specifically recommend to the health agencies in the US that such epidemiological, and indeed long-term injury research should be carried out?

In the documentary Professor Lader called on Roche, the drug company that discovered benzodiazepines and made a fortune with Valium from the 1960s onwards, to fund such research “from past profits.” 

While it is progress for the FDA in recognition of the dangers, it is far too late and far too limited in listing the severe long lasting side effects that can injure patients, many of whom suffer multiple symptoms. It is also worth noting that, ironically, the danger of seizures from abruptly ceasing the drugs was first reported in the US in a 1961 study carried out by Dr. Leo Hollister on the first Roche benzodiazepine, Librium, even before Valium was launched. Hollister’s study of a group of patients taking and stopping Librium was ignored by governments and the industry. We have no knowledge of the number of patients who have died because of this as the deaths would never have been attributed to the drugs.

Bernie Silvernail, founder and director of the US Alliance for Benzodiazepine Best Practices, said that “more than 20 voluntary organizations with over a hundred thousand members worldwide have been dedicated for years to informing the world of the dangers of benzodiazepines. Some 30 years after Ashton and Lader warned us, it is good to see that the FDA has finally reviewed the data it collects and agrees with the need to change benzodiazepine prescriptive practice.” 

There is still an issue of concern about the FDA statement, mixing misuse, abuse, and addiction with the distinctly separate and more insidious issue of continuing harm and injury that is caused through medical prescriptions to patients. The FDA conflation of these categories in relation to prescribed benzodiazepine drugs has done almost as much harm as the drugs themselves. Its approach is still flawed, acknowledging the therapeutic prescription dangers, but then turning immediately to words facilitating patient blaming. So, when a patient is prescribed the drug and takes it as prescribed, and is injured, the patient can be accused of misuse, abuse and addiction. That unfortunately is what has been happening for more than half a century.

Its approach is still flawed, acknowledging the therapeutic prescription dangers, but then turning immediately to words facilitating patient blaming. So, when a patient is prescribed the drug and takes it as prescribed, and is injured, the patient can be accused of misuse, abuse and addiction.

This has contributed to a reticence among patients to insist on attributing bizarre and extremely painful symptoms to the drugs. In my opinion it is worth investigating the occurrence of the diagnosis of Fibromyalgia alongside the prescription of benzodiazepines. The severe neurological pain caused by benzodiazepines is remarkably similar to that associated with Fibromyalgia. This investigation should be done, even if it is just to rule out a link with the mysterious condition, so long as the study is carried out honestly. Unfortunately, again, many studies of the drugs have often been motivated by career advancement, contain nothing of value, and frequently have been misleading or inaccurate. (See also Can Medicine be Cured by Professor Seamus O’ Mahony and the work of Robert Whitaker in the USA)

Campaigners are hopeful that the newly aware FDA realises that this complex situation requires an approach stressing the harms and injuries particularly the disabling long lasting side effects. That would have a hugely beneficial effect on the health of people worldwide prescribed benzodiazepines, making doctors and patients much more careful. If it had been done in the US decades ago many among the 300,000 FDA complainants could likely have avoided their suffering. I suggest these box warnings:

DO NOT TAKE FOR MORE THAN 2-4 WEEKS – RISK OF SERIOUS LONG-TERM DISABLING INJURY. IN WITHDRAWAL DO NOT STOP ABRUPTLY – RISK OF SEIZURE AND DEATH.

The use of such warnings in a black box worldwide, could save many from disabling illness and potential death. Ashton called the scourge of prescription induced benzodiazepine illness “a pandemic all over the world,” words that resonate now. Today we have the means to finally eradicate this prescription plague after half a century.

If it had been done in the US decades ago many among the 300,000 FDA complainants could likely have avoided their suffering.

Ashton ran a clinic in the UK for 12 years treating victims of benzodiazepine injury and reported that side effects/withdrawal symptoms could start while patients are taking benzodiazepines, as prescribed, at normal therapeutic doses. Everything acknowledged and proposed by the FDA was indicated in her studies of the 1980s and her legendary Manual on benzodiazepines, published on the internet in the early 1990s. When I interviewed her, she stressed that her understanding of the harms caused by BZs grew because she listened to her patients: They were the experts on the symptoms they were suffering. With its review of complaints, the FDA is now finally using this ‘best practise’. 

Ashton with her Manual was the friend, consultant and advocate for patients, doing the job of governments, medical bodies and consumer protection agencies worldwide for decades when patients got no succour from those responsible for caring for and protecting them.

The FDA now has an opportunity to change that story. Let’s hope they continue to advance beyond the important Rubicon they have already crossed with their new warnings of the dangers of benzodiazepines. In this matter the US has already finally shown some honourable medical leadership.

* Italics are the author’s emphasis.

The Benzodiazepine Medical Disaster can be viewed freely on Vimeo or YouTube.

Vimeo link: https://vimeo.com/188181193

YouTube link: https://www.youtube.com/watch?v=MVoFlGR7Lhs

 

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