Dec. 2, 2020 – The FDA has not produced a report on the hundreds of thousands of complaints that have been made to them about BZDs, but just 104 “focused case series,” in the FDA Adverse Event Reporting System (FAERS).
Critically, the FDA now acknowledges a serious problem for those prescribed BZDs:
“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 goes on to say: “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 U-turn for the FDA, a return to form for an agency which garnered national and international fame for refusing to licence Thalidomide in the 1960s, saving the US from the widespread devastating birth deformities the drug caused.
The FDA was first formally asked a decade ago to accept the real dangers of BZDs and do what they are now doing. This came in a Citizens’ Petition in 2010 signed by thousands of those injured by prescribed BZDs, as well as concerned professionals, led by the late Professor Heather Ashton, a renowned world expert on BZDs who died last year.
The Petition called for a black box warning on the packaging of BZDs, but that was ruled out in a breathtaking 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 black box warning not to take BZDs with opioids while the controversy about opioid deaths was raging.
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