Recent FDA News Release: Benzodiazepines Boxed Warning to Be Updated to Include Serious Risks

On September 23rd, the U.S. Food and Drug Administration (FDA) announced that it would be requiring “class-wide labeling changes” for psychoactive drugs that fall under the class of Benzodiazepines. The label change to the Boxed Warning will include benzos’ risks of abuse, dependence, misuse, addiction and potential withdrawal symptoms. 

The labeling update is a reaction to the common abuse of benzos that lead to addiction and withdrawal for many patients who misuse them. Here, the pharmaceutical liability attorneys at Peter Angelos P.C. share insights from the recent FDA press announcement to spread awareness of the potential dangers of misusing benzos and why it is important for potentially addictive substances to exhibit proper warning labels. To view the full press release, click here.

 

Psychoactive Drug Class Benzodiazepine is Comprised of Mild Tranquilizers Used to Sedate Patients

Benzodiazepines are used to treat a variety of conditions such as anxiety, panic disorders, spasms, epilepsy, insomnia and more. As tranquilizers, effective benzos typically calm or sedate individuals who suffer from mental or physical disorders associated with nervousness or anxiety. They work by increasing the levels of GABA, an inhibitory neurotransmitter, in the brain to calm and relax the individual experiencing anxiety, sleeping problems or another condition that may require sedation. Common types of benzos include Xanax, Valium and Librium. Benzos are often prescribed for short-term use, such as for patients who may suffer anxiety regarding airplanes and may benefit from mild sedation during their flight. Others may use benzos for a short to intermediate-term use if they suffer from regular insomnia or panic attacks. 

Benzodiazepine use is common; it is estimated that 92 million benzodiazepine prescriptions were filled and dispensed in the United States in 2019. While the dose and term of treatment vary on an individual basis, millions of patients have used benzos to treat stress, anxiety or panic disorders, many for a duration that exceeds several months.

 

Benzodiazepine Can Lead to Physical Dependency if Misused

According to the latest FDA press release, taking benzos regularly for several weeks to months can suffer withdrawal symptoms upon abruptly ceasing treatment. Physical dependency to benzos can develop after regular usage for several days or weeks. The FDA’s decision to update the Boxed Warning to include the risks of physical dependency, abuse, misuse, addiction and potential withdrawal reactions is a result of the prevalence of the misuse of benzos, often in conjunction with opioids. This action is also a part of the FDA’s effort to protect public health by “minimizing risks associated with inappropriate use of controlled substances,” as reported in the FDA news release.

 

The Baltimore Pharmaceutical Liability Attorneys at Peter Angelos P.C. is Actively Taking Cases

If you or a loved one was prescribed Benzodiazepines by your doctor to treat a mental or physical condition and now suffers physical dependency or even addiction to Benzodiazepines, you are acutely aware of the pain it can cause you and your family. The Baltimore pharmaceutical liability attorneys at Peter Angelos P.C. are prepared to help victims and their families who have been harmed by pharmaceutical companies seek the compensation they need and deserve. Contact us for a free consultation today: call 410.649.2000 or visit https://www.angeloslaw.com/contact/.