The Food and Drug Administration (FDA) is advising people to stop using a drug called Clarity on the basis of safety and efficacy and to look for a new drug.
FDA spokesman Joe Baca said in a statement Monday that Clarity is the first drug to be tested in a Phase 2 study of the drug, and that it will undergo additional testing and analysis to confirm its safety and effectiveness.
Baca said Clarity, which was developed by the Biogen Idec company, is not being sold as a replacement for any other drug, but rather to treat a common type of depression that affects roughly 6 percent of the U.S. population.
Clarity was first approved in the U, U.K. and Canada in 2016 and has been licensed to treat some patients in the Netherlands, Spain and Switzerland.
The drug is not approved for people with a history of psychiatric illnesses, such as bipolar disorder or schizophrenia.
The FDA has been testing Clarity since last summer.
It will conduct additional safety studies to confirm the safety of Clarity and its use, Baca added.
The FDA said it would issue guidance in the coming weeks, and it will provide information about how to take Clarity if you are taking it.
For patients with an anxiety disorder, Clarity’s label says it will help alleviate anxiety symptoms, including sleeplessness and panic attacks.
“We’re hopeful that this will lead to a new generation of Clares, which will be able to help relieve the burden of anxiety that affects millions of people in the United States,” Baca wrote in the statement.
Earlier this month, the FDA announced it would not be taking Clarity.
The agency said that Clares is already available to people with an existing depression that was diagnosed in 2016, so the new drug was not warranted.
Some insurers and insurers are offering discounts to people who take Clares instead of a new antidepressant.
But Baca did not say how much people will pay.
In 2018, the CDC and the National Institutes of Health (NIH) approved Clarity for the treatment of major depression in adults, and more than 1 million people have received it.
The Drug Enforcement Administration said in August it had approved Clares to treat patients with depression who had not responded to standard treatment.