The Food and Drug Administration now require stronger warnings on their labels certain painkillers and drugs for anxiety, alert doctors and patients about the risk of combination of drugs .
The new requirements for opioid analgesics (including oxycodone and hydrocodone) and benzodiazepines follow an increase of 41 percent in the number of patients prescribe both classes of drugs in the last decade and the consequent increase in overdose deaths in which they are used together. According to the FDA, this type of overdose deaths tripled between 2004 and 2011.
The agency is now requiring boxed warnings on the labels of opioids, which explains the danger of using drugs in combination with benzodiazepines, and vice versa. It will also be required to cough prescription opiates to carry a warning about its use in combination with benzodiazepines.
“warning label highlight the need for change, the need for greater attention,” said Dr. Doug Throckmorton, deputy director of the FDA Center for Drug Evaluation and Research, in a call with reporters. “We believe that will restore conversation about using these products together.”
More than 80 million patients in the United States prescription opioids were dispensed in 2014, and 30 million benzodiazepines received, which are used to treat anxiety, insomnia and muscle spasms. According to the agency, almost 1 in 3 deaths from unintentional overdoses involving these two classes of drugs used in combination. Throckmorton also said that at least half of opioid and benzodiazepine prescriptions received by the same person was prescribed the same day by the same doctor.
The risks in using these drugs together has been known for some time, FDA officials said, but the new data on the number of visits to the emergency room and deaths led the agency to Wednesday’s announcement. The requirements apply to 389 products, according to FDA Commissioner Dr. Robert Califf’s.
Dr. Leana Wen, Health Commissioner of Baltimore City and one of the public health officials who pushed the FDA to require stronger warnings, told reporters that prescribing the two drugs together he had become routine clinical practice, despite being “scientific no reason” to do so.
Someone who was in a car accident may be prescribed an opioid for pain and benzodiazepine to muscle spams. Or a patient taking a benzodiazepine for anxiety could then be prescribed an opioid and your doctor does not necessarily ask if they were taking medication anxiety, Wen said.
“There is no scientific reason why medical training in which I was taught to prescribe benzodiazepines and opiates together. Like many other things, doctors and doctors do things the way we do because it is routine care, “Wen said. “This is something that has happened in recent years because no malintent, not because of a desire to do something bad for the medical profession.”
The FDA is also issuing more detailed instructions for patients explaining the risks of the combination of opioids and benzodiazepines and a public notice to push that information to the public directory.