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FDA Calls for Boxed Warning on Two Drug Classes

Posted 31 August 2016 | By Michael Mezher 

FDA Calls for Boxed Warning on Two Drug Classes

The US Food and Drug Administration (FDA) says it is requiring two classes of drugs, opioids and benzodiazepines, to bear a boxed warning over serious and sometimes fatal risks when the two drugs are used in combination.

"It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together," said FDA Commissioner Robert Califf. "We implore health care professionals to heed these new warnings more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or CNS depressants more generally – together outweigh these serious risks."

FDA says the boxed warning, the agency's strongest, will be added to the label of 389 branded and generic drugs containing either product. In addition to the boxed warning, FDA has issued a new safety advisory on the combination to patients and healthcare providers and is requiring companies that market the drugs to issue new "patient-focused" medication guides.

The announcement comes in the midst of a nation-wide opioid epidemic which claims the lives of tens of thousands of Americans each year. According to FDA, the combination of the two drugs, both of which are central nervous system depressants, can cause serious adverse effects, including extreme sleepiness, respiratory depression, coma and death.

According to FDA, the number of prescriptions for the two drugs increased significantly between 2004 and 2011, with the number of deaths involving both drugs nearly tripling during that time.

Prior to today's announcement, both opioids and benzodiazepines warned against combining the drugs with other central nervous system depressants; however, FDA says the boxed warning will raise awareness of the risks by being more specific and visible.

In February, a coalition of 41 officials representing city, state and US territories health departments filed a citizen petition calling on FDA to add the boxed warning to the two drugs in response to increasing overdoses and deaths linked to the combination.

One of the leaders of the effort behind the citizen petition praised the move by FDA, calling the black box warning "a powerful educational tool."

FDA, Safety Advisory


Categories: Regulatory News

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