Patients are struggling amid a shortage of a common anti-anxiety medication – with no sign of when it will be restocked.
Buprisone is regarded as one of the safest treatments for anxiety because it is less addictive, less lethal, and with fewer side effects than benzodiazepines like Valium. It is also cheaper.
However, a third of the country’s supply has been cut off after an FDA inspection of a Mylan factory in West Virginia, which produces the drug, found it to be dirty and failing in quality.
The factory was forced to cease all production until the FDA is satisfied that changes have been made – and there is no date set for restarting.
Psychiatrists warn the ramifications can be severe for people struck by the shortage.
Those who go a few days without buprisone may experience a sudden return of the symptoms that drove them to take medication. Many have described suffering withdrawal symptoms, including the notoriously painful ‘brain zaps’ – jolts of white light and buzzing.
A third of the country’s buprisone supply has been cut off after an FDA inspection of a Mylan factory in West Virginia, which produces the drug, found it to be dirty and failing in quality
Beth Salcedo, MD, board president of the Anxiety and Depression Association of America said she is concerned that, when it comes to medications for mental disorders, there is often a lack of urgency to resume production.
‘Anxiety is associated with suicide so this drug is as important as anything else when it comes to life-saving,’ Salcedo told DailyMail.com.
‘The FDA needs to look at it that way. When you see the suicide rate going up, we need to be careful about keeping our risk factors in check.’
Paul Crosby, MD, chief medical officer at the Lindner Center of Hope in Mason, Ohio, concurred.
‘Sometimes it’s easy to look at this and say “this isn’t life-threatening, it’s anxiety,”‘ he told DailyMail.com.
‘But somewhere between 20 and 25 percent of the US population experiences a diagnosable anxiety disorder every year. And when you consider depression, that’s the leading cause of disability.
‘This isn’t a minor issue, this is a pretty big deal, and there’s real suffering and morbidity when people experience shortages.’
In 2017, there were 13.5 million buprisone prescriptions filled, up from 10.2 million in 2015.
Buprisone, once sold as Buspar but is now only sold as a generic, tends to be a treatment that patients are prescribed after other anti-anxiety medications fail.
That’s partly because the clinical trials for buprisone took a general scope, using it for people with various anxiety symptoms.
For a patient’s first anti-anxiety prescription, doctors are more likely to put them on an SSRI (Selective serotonin reuptake inhibitors) like Prozac or Zoloft, because there are many of them and each may target more specific things.
Anecdotally, Dr Crosby said, some physicians have said they feel SSRIs are more effective, and ‘there’s some debate about the effectiveness of Buspar.’
But as the US grapples with various addictions, buprisone is a nice low-risk alternative for doctors: it is less addictive with fewer side effects, and it rarely interacts badly with other drugs (unlike SSRIs).
In fact, it is even prescribed in tandem with many antidepressants to balance out and treat the side effects.
The problem is that there aren’t really any other low-risk alternatives, warns Anna Lembke, MD, a Stanford professor of medicine and author of Drug Dealer, MD – a book which warns addiction to anxiety medicines is being ignored.
Dr Lembke has only heard of one case of Buspar addiction. Compared to ‘benzos’ it is a much more comforting pill to recommend.
‘We have a lot of high-risk drugs that people over-prescribe for various reasons, but we don’t have a wide range of low-risk drugs’ – making its shortage more of an issue.
What’s more, buprisone is mainly used by patients who have run out of other options. And switching to another drug is not only stressful, but often won’t work.
Buprisone is in a class of its own, there aren’t any drugs like it.
A different drug will likely have a different effect, and may not work. Even for drugs that do have similar alternatives, switching between from one to the other can prove futile or painful.
That leaves patients forced to ration their doses.
‘At the least it’s highly frustrating and at the worst it can case the to have significant and potentially life-threatening symptoms,’ Dr Lembke said.
The FDA has been fairly quiet about the shortage. None of the doctors DailyMail.com spoke to had heard of any of their patients being affected by the shortage, which has lasted a couple of weeks. But often, it’s not clear how long these shortages can last, especially for generic drugs (as opposed to brand-name drugs).
Dr Crosby said shortages are becoming more common.
In shortages that he’s seen before (usually ADHD medications like Adderall which are very tightly controlled), it has lasted days, weeks or even months, with rarely any notice from the FDA about a timeline.
A spokesman for the FDA said in an email: ‘I can confirm that FDA is continuing to work with Mylan and the other manufactures on availability.’
Myland said in an emailed statement: ‘As part of the ongoing restructuring and remediation activities at our site in Morgantown, Mylan has experienced supply interruptions affecting a number of products, including some psychiatric medications. We understand the burden this puts on our customers and the patients we serve. We encourage patients to check the FDA drug shortage database to confirm the latest supply status and the availability of comparable products made by other manufacturers. For instance, in the case of buspirone, we believe there are at least four other suppliers actively selling that product. In addition, we encourage patients to consult with their physician regarding alternate therapies.’