Black Box Warning Added to Xanax, Other Benzodiazepines

The FDA announced this week that it is requiring an updated Boxed Warning for all benzodiazepine medications, including Xanax and Valium, to include the risk of abuse, addiction, physical dependence and withdrawal reactions. Benzodiazepines are some of the most widely prescribed medications on the market in the United States, and they have qualities that can effectively reduce anxiety, induce sleep and relax the muscles, which makes them useful in treating a variety of conditions. However, even at recommended doses, benzodiazepine use can cause addiction, physical dependence and withdrawal reactions, and misuse can result in overdose or death. If you or someone you love has been adversely affected by alleged benzodiazepine side effects, contact us as soon as possible to find out how we can help.

Potential Side Effects of Benzodiazepines

Xanax and other benzodiazepine medications are frequently prescribed to treat anxiety, insomnia, seizures and panic disorder. Unfortunately, the FDA warns that regular benzodiazepine use can lead to abuse, dependence and addiction, which can result in overdose or death, especially when the drugs are used in combination with alcohol, illicit drugs or opioid pain relievers. “The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately,” the FDA warns in a new drug safety communication, released on September 23. “This increases these serious risks, especially when benzodiazepines are used with some other medicines and substances.”

According to the FDA, a person taking benzodiazepines can develop a physical dependence after using the drugs steadily for several days or weeks, even when using them as prescribed. Stopping the use of benzodiazepines abruptly or reducing the dose too quickly can also cause withdrawal symptoms, such as seizures, which can be life-threatening. In order to provide patients and healthcare providers with more accurate information about the serious risks associated with the benzodiazepine class of medications, the FDA is requiring an update to the Boxed Warning – the FDA’s most prominent warning – for all benzodiazepine drugs, including Xanax and Valium. The agency is also requiring changes to the prescribing information for the benzodiazepine class of medications, describing the risk of benzodiazepine abuse, misuse, addiction, dependence and withdrawal across all drugs in the class.

What are Benzodiazepines?

Benzodiazepines, known colloquially as “benzos,” act as sedatives. The drugs are designed to reduce brain activity by binding to gamma-aminobutyric acid (GABA) receptors in the brain, thereby causing drowsiness, reduced anxiety and muscle relaxation. The first benzodiazepine drug to be approved by the FDA was chlordiazepoxide (Librium), approved in 1960, and in the years that followed, many other well-known medications in this class entered the market in the United States, including alprazolam (Xanax), diazepam (Valium), lorazepam (Ativan) and clonazepam (Klonopin). In 2019 alone, approximately 92 million benzodiazepine prescriptions were dispensed by U.S. pharmacies, the most common being alprazolam (38%), clonazepam (24%) and lorazepam (20%).

FDA Warnings About Benzodiazepine Health Risks

In reviewing adverse events reports submitted to the FDA, postmarketing databases and published literature on benzodiazepines abuse, withdrawal and addiction, federal regulators found that benzodiazepines are widely prescribed in the U.S. and are also widely abused and misused, which poses serious health risks. “While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol and illicit drugs,” said FDA Commissioner Stephen M. Hahn, M.D. “We are taking measures and requiring new labeling information to help health care professionals and patients better understand that while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction and dependence.”

This is not the first time the FDA has warned that misusing benzodiazepines can pose serious health risks for users, especially when the drugs are taken in combination with other drugs, like opioids, which are used to treat pain. Back in 2016, the agency issued a drug safety communication warning patients and healthcare providers about the potential for combined use of benzodiazepines and opioid medications to cause severe side effects, including slowed or difficult breathing and death. In an effort to limit the combined use of benzodiazepines and opioids, or opioids and other drugs that depress the central nervous system, the FDA added Boxed Warnings to the drug labels of benzodiazepine drugs, prescription opioid painkillers and prescription opioid cough medicines.

Contact an Experienced Drug Injury Lawyer Today

Benzodiazepine dependence can occur after just a few days or weeks of regular use, and patients who take a benzodiazepine medication for several weeks or months may experience withdrawal symptoms if they suddenly stop using the drug or try to wean themselves off with lower dosages. If you have experienced a serious side effect like benzodiazepine addiction or dependence, or if a loved one died from a benzodiazepine overdose, do not hesitate to speak to a knowledgeable drug injury attorney about your legal options. Contact us today to find out if you are eligible to file an injury or wrongful death claim against the drug manufacturing company.