The FDA is now proposing new guidelines for Benadrile and other antipsychotics, in response to a public outcry about the increased risk of autistic disorders and other disorders linked to the drug.
The agency’s proposed guidelines come a day after it announced that it had approved a drug called Lantus, the first drug to be approved by the FDA for the treatment of autism spectrum disorders.
The FDA said that Lantu, marketed as Benadril, is an antipsychotic that can reduce the risk of developing autism.
The announcement comes as lawmakers are considering new restrictions on the use of the antipsychos and the other drugs, which have been around for decades.
A number of the most widely used antipsychoses and the drugs that have been approved to treat them have been associated with autism and other neurodevelopmental disorders, including attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), and Tourette syndrome.
In a letter to the FDA last week, pediatricians, researchers and other experts urged the agency to change the guidelines and focus more on the safety of the drugs.
The new guidelines will be released by the end of April, and they should be updated annually, the agency said.
The FDA’s new guidelines, published in The New England Journal of Medicine, say that the new drugs have been shown to be safe for most children and adults, including those with autism.
The drugs work by targeting a specific gene, which is expressed by neurons in the brain.
The drug is called Lantsar and it was approved for the first time in the United States last October.
“The proposed guidelines would have us focus on the most important safety issues for children with ASD and other developmental disorders,” said Dr. Sarah J. Wolk, director of the University of Pennsylvania Center for the Study of Autism and Related Disorders.
As a precautionary measure, the FDA has asked drug makers to submit updated data on how well their products work in children.
The FDA also said that children with autism have been using antipsychics for years, so they should not be put off from taking them.
The proposed changes come as lawmakers and advocates are weighing a package of bills that would require manufacturers to include the names of children who have been diagnosed with autism in the label of any antipsycho or other drug.
Several states, including California and Connecticut, have passed laws that would have forced the FDA to include such information in the drug labels.
A spokesman for Rep. Tom Marino (R-Pa.), a sponsor of the bills, said that the congressman believes that labeling of children with the disease should include a child’s full name and that he would work with lawmakers to move forward on that issue.
In March, the Centers for Disease Control and Prevention (CDC) issued a statement saying that more research is needed into the safety and efficacy of these antipsychopics.
“These medications are not a panacea and the FDA does not endorse any specific medication,” CDC Director Dr. Anthony Fauci said.
“We must be sure that our drugs work as advertised, and that they are safe for children and the general population.”
The agency said that it does not consider any specific drug to cause autism, but that it is aware of studies that suggest it could.