A sudden shortage of one of the safest anti-anxiety drugs on the market has spread alarm among people who rely on the medication, buspirone, to get through the day without debilitating anxiety and panic attacks. Physicians are also expressing concern, because there is no information about when the supply will resume, making it difficult to manage patients.
Shelby Vittek, a 27-year-old writer in New Jersey, fruitlessly called dozens of drugstores in New Jersey and Pennsylvania in an attempt to locate the medication after her pharmacist told her the drug was on back-order with no end in sight. She ended up weaning herself off the drug, spreading her last three pills over six days to avoid having to go “cold turkey” before starting a difficult transition to an antidepressant. “I pretty much lost over a month of work, and have just started to feel like myself again,” she said.
A 34-year-old New York woman who couldn’t get her buspirone refilled in January said she couldn’t sleep and had such severe panic attacks that she had to use Klonopin, a drug she dislikes because it is addictive. “I’m trying to take care of my anxiety, and it’s giving me a panic attack,” said the woman, a sexual assault survivor who asked not to be identified.
A Pennsylvania medical school student received her mail-order shipment of medication last week with no buspirone in it and no explanation, so she scrounged around the house and dug up old pills from missed doses. Last weekend, the student, who asked not to be identified, was so anxious she could not leave the house.
“This is potentially messing with people’s clinical stability,” said Dr. Dennis Glick, a psychiatrist in Greenbelt, Md. “When you have a patient with a complicated and balanced regimen, you really don’t want to just arbitrarily have someone come off the medicine.” Dr. Glick said he has been in practice for 34 years “and I honestly don’t recall issues like this interfering with care until maybe a couple of years ago.”
Persistent shortages have plagued hundreds of drugs in recent years, from morphine to intravenous fluids, and many psychiatric medications used to treat schizophrenia, as well as some stimulants used to treat attention deficit hyperactivity disorder, are in short supply. Some of the worst shortages are of generic, or non-brand-name, drugs like buspirone, whose prices have been driven so low that many manufacturers say they cannot turn a profit on them.
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One in five Americans has had an anxiety disorder in the past year, according to the National Institute of Mental Health, though relatively few use buspirone, and doctors are of mixed opinions about its effectiveness. But experts say it is a much safer drug than the benzodiazepine anti-anxiety drugs like Valium and Xanax and is unlikely to cause harm from an overdose or when combined with other medications like opioids. It is not addictive, has few side effects, does not cause sexual dysfunction and is remarkably inexpensive.
It can also be used to augment antidepressants and help to alleviate sexual dysfunction caused by antidepressants.
And it’s almost impossible to replace with an alternative drug because unlike the S.S.R.I. antidepressants, for example, where there are five or six options, there is no equivalent medication that works the same way. “Buspirone is in a class by itself. It occupies a unique niche,” said Dr. Elias Aboujaoude, a clinical professor and chief of the anxiety disorders section at Stanford University School of Medicine.
For a patient with anxiety and a history of depression, conditions that often overlap, “you may want to avoid a benzo because they can also be depressants, and buspirone can be a safer, more reasonable option,” he said.
Patients also do not have the choice of paying more to buy the brand-name version of buspirone, Buspar, because it is no longer made.
Buspirone prescriptions dispensed in the United States rose to 13.5 million in 2017 from 10.2 million in 2015, with the number estimated to reach nearly 15 million last year, according to IQVIA, a health care technology and data analytics provider. The reasons for the increase are unclear, though the opioid epidemic may have made some physicians more reluctant to prescribe highly addictive anti-anxiety medications that can be lethal when combined with opioids.
The main reason for the buspirone shortage appears to be interrupted production at a Mylan Pharmaceuticals plant in Morgantown, W.Va., which produced about a third of the country’s supply of the drug. The Food and Drug Administration had said the facility was dirty and that the company failed to follow quality control procedures.
Mylan has told the F.D.A. the date for resuming buspirone production is “T.B.D.”
“Companies don’t have to tell the F.D.A. how long the shortage is going to last or when they expect it to be back,” making planning difficult for doctors and patients to manage, said Erin Fox, senior pharmacy director at University of Utah Health and director of its Drug Information and Support Services.
Most drug manufacturing plants are already running at full capacity so “when one shuts down even for a short period of time, there is no resiliency in the supply chain for anyone else to make up the difference,” Dr. Fox said.
Rock bottom prices for some generic drugs are also contributing to the crisis. Consolidation among wholesalers has led to the creation of three buying consortium behemoths that purchase 90 percent of the generic pharmaceutical products in the United States, said Adam Fein, a consultant and chief executive of Drug Channels Institute. These “monster” buyers have squeezed manufacturers on prices, and “some of those generic manufacturers are deciding the profit is so low they can’t make money, and they’re exiting the category,” Dr. Fein said.
At least one relatively small buspirone manufacturer, Impax, has left the market.
“Drugs like buspirone are not considered critical or lifesaving drugs by the F.D.A.,” said Dr. Beth Salcedo, president of the Anxiety and Depression Association of America. “But the reality is that when you look at anxiety and depression, we lose a lot of people every year to these illnesses.”