�鶹Ů��

The Food and Drug Administration announced on Wednesday that it would require its toughest warning labels to caution patients against taking opioid painkillers together with benzodiazepines, like Xanax and Valium. The combination makes an overdose more likely and the warning is aimed at making sure people understand that. Benzodiazepines are prescribed for anxiety, insomnia and seizures, and opioids for pain. The drugs work by depressing the central nervous system. Increasingly, doctors have been prescribing them together. The number of patients who were prescribed both drugs rose by 41 percent — about 2.5 million people — from 2002 to 2014, the agency said. (Tavernise, 8/31)

The Food and Drug Administration said it will add a boxed warning — the strongest type — to nearly 400 medications about the interaction, including opioid painkillers, opioid-containing cough medicines and benzodiazepines, which are used to treat anxiety, insomnia and seizure disorders. (Perrone, 8/31)

In a call with reporters, FDA Commissioner Robert Califf implored doctors “to heed these new warnings” and to carefully evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines together outweigh the serious risks involved. Current labels on the drugs warn of potentially dangerous interactions. But FDA officials said the tougher warnings, sometimes called “black box warnings,” are designed to catch the attention of physicians and patients and to underscore the seriousness of the threat. (McGinley, 8/31)

The move comes after an extensive review of scientific evidence by the FDA showing that physicians have been increasingly prescribing these drugs together. There was also a request for action in February, when health officials in cities and states across the country petitioned the agency for the change to the drug labels, citing an increase in overdoses from simultaneous use of the drugs. (Neel, 8/31)

The new FDA order calls for some 400 products to carry one of several “black box warnings.” Those aim to alert physicians and patients to the dangers of mixing opioids with benzodiazepines and other drugs — including insomnia medications, muscle relaxants, antipsychotic drugs and alcohol — that depress the central nervous system. The new warnings tell physicians and patients that the combined use of drugs that reduce the reflexive urge to breathe can cause dizziness, extreme sleepiness, slowed or difficult breathing, and unresponsiveness. (Healy, 8/31)

Dr. Leana Wen, Baltimore’s city health commissioner and one of the public health officials who pushed the FDA to require stronger warnings, told reporters that prescribing the two drugs together had become routine clinical practice, despite there being “no scientific reason” to do so. (Scott, 8/31)

“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,” FDA Commissioner Robert Califf said in a statement. (Wheeler, 8/31)

The FDA has been heavily criticized for doing too little to stop overuse and abuse of opioids such as OxyContin, Vicodin and Percocet. The drugs, which are similar to morphine and heroin, are highly addictive and are easy to overdose on. (Fox, 8/31)