The Food and Drug Administration is cracking down on labeling requirements to help to put an end to the increasing drug epidemic plaguing the U.S.
The FDA announced on Tuesday that immediate-release opioid prescription pain medications, which are the drugs that are supposed to be taken every four to six hours, will now have to come with a label that warns against the risk of abuse, addiction, overdose and even death.
The new warning labels will be added to over 200 types of opioids, including OxyContin and Vicodin, two drugs that are commonly abused. According to the Centers for Disease Control and Prevention (CDC), more than 28,000 people have died from reported opioid overdoses in 2014. This includes both prescription opioids and its street version heroin.
The update to the drug labels would include even clearer instructions for the patient when it comes to taking their prescriptions, such as the initial dosage and changes to the dosage during therapy. However, it will also advise not to stop treatment for patients that become physically dependent. Instead, opioids like Methadone and Buprenorphine are often used to help the patient wean themselves off the immediate-release (IR) opioids.
Changes to the labels on IR opioids will also warn pregnant women that continuous use can result in their babies suffering from Neonatal Opioid Withdrawal Syndrome, where their child can be born hooked on the drug. This syndrome could be life-threatening if not recognized and treated.
The agency will also now require IR opioids and extended-release/long-acting medications (prescriptions taken once or twice a day) to feature safety information on its labels that would advise patients of potentially harmful effects caused by interactions with other drugs. The labels will also inform against the drugs' effect on the endocrine system, which includes a rare disorder of the adrenal glands, as well as a decrease in sex hormone levels.
"Today's actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic," Robert Califf, M.D., FDA commissioner, said in a press release.
However, some critics believe that adding abuse and overdose warning labels on the drugs will not actually prevent addiction and possible death — especially since it's widely known that people can grow dependent on these types of drugs.
This is not the first time the FDA has taken an active role in fighting back against drug addiction. In 2013, the FDA cracked down on the labeling of extended-release opioids, requiring that their labels better explain the risks, as well as highlight that these medications should only be used when the patient is in severe pain.
The new FDA label requirements come just one week after the CDC issued national guidelines for physicians on the use of opioids. These guidelines, which are the first of their kind, advise doctors to use serious discretion before prescribing medication that is extremely addictive.
Source: FDA
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