Health officials in the US have announced a crackdown on a growing number of new drugs, warning they will not be allowed on the market until they prove to be safe and effective.
The US Food and Drug Administration (FDA) on Monday decided to tighten the rules for new drugs to ensure they have “sufficient safety, efficacy and tolerability to warrant approval”.
The move comes after the US Senate passed a bill on Wednesday which would prevent the use of the highly toxic and controversial ketamine for treating the mentally ill, with some doctors expressing concern about its potential side effects.
However, the drug is already being used by patients in several countries, including in Europe.
Many US states have also enacted restrictions on the drug, with Florida and Ohio among those states now banning its use for mental illness.
The move to limit the use for the mentally and the elderly comes at a time when the number of US patients using ketamine to treat depression has skyrocketed.
The drug is also increasingly being used in Europe, where the number has risen to nearly 30,000 people a month.
In 2015, it was sold in the UK for an average price of $100 per tablet, while in the USA, it is sold for about $250.
Ketamine is a serotonin agonist and it can cause a spike in blood pressure, panic attacks, anxiety and confusion.
The new rules, however, will not prevent the drug from being used for psychiatric conditions such as schizophrenia or bipolar disorder.
They also apply to all drugs that contain serotonin or serotonin derivatives, and they will only apply to those approved by the FDA.
However the US Drug Enforcement Agency (DEA) said that ketamine is not currently classified as a drug that poses a “high” or “high-risk” to the public.
“The FDA has already issued a warning letter to several companies warning them of possible serious adverse effects of this drug, including respiratory depression, tachycardia, agitation, confusion, hallucinations, confusion and incoherence,” the agency said.
“This drug should not be used for treating anyone with mental illness and the FDA has issued no warnings or restrictions for its use.”