When medications pose serious or life-threatening risks, the U.S. Food and Drug Administration (FDA) requires manufacturers to display warnings enclosed in a bold black border on their packaging and prescribing information. These alerts, known as FDA black-box warnings, are the strongest safety precaution the agency can mandate while still allowing a drug to remain on the market.
Why Does the FDA Issue Black-Box Warnings?
The FDA oversees a rigorous drug evaluation process, which includes initial laboratory studies through clinical trials and ongoing monitoring after the medication is released to market. Black-box warnings emerge when the evidence reveals severe adverse reactions that could result in death or serious injury. The FDA has the authority to add these warnings at any point in a medication’s lifecycle, even years after initial approval. Ozempic is an example of a drug that currently has a black box warning. Ozempic injury lawsuits allege that the medication has caused a number of injuries, ranging from kidney failure to vision loss.
Examples of Medications with FDA Black Box Warnings
Over 400 medications currently carry black-box warnings, spanning a range of drug classes and medical conditions. These include:
- Benzodiazepines: These anti-anxiety medications, including popular drugs like Xanax, Klonopin, and Valium, carry black-box warnings due to their serious risks of addiction, abuse, and life-threatening withdrawal symptoms. The label also warns about dangerous interactions when combined with opioids that can lead to severe respiratory depression.
- Antidepressants: Selective Serotonin Reuptake Inhibitors (SSRIs) like Prozac, Zoloft, and Lexapro display black-box warnings because they can increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults, especially during the first few months of treatment or when dosages are adjusted.
- Opioids: Prescription pain medications such as OxyContin, Vicodin, and fentanyl carry black-box warnings for their high potential for addiction, abuse, and fatal overdose, as well as the risk of opioid withdrawal syndrome in newborns when mothers use these drugs during pregnancy.
- Medroxyprogesterone: The injectable contraceptive Depo-Provera carries a black-box warning because long-term use can lead to significant loss of bone mineral density, potentially increasing the risk of osteoporosis and bone fractures. This risk is especially high for adolescent and young adult women.
- JAK Inhibitors: Certain medications used to treat autoimmune conditions, including Xeljanz, Olumiant, and Rinvoq, display black-box warnings for increased risks of serious cardiovascular events, blood clots, certain cancers, and death.
Your Rights When Prescribed Drugs with Black Box Warnings
When you take a medication, you deserve to know all of the potential risks and side effects before beginning your treatment. Healthcare providers must discuss these topics with you, including black-box warnings. You can then make an informed decision on whether to take the drug based on this information.
However, not all drug manufacturers disclose known risks on medication labels. If you develop a medical condition or suffer injuries that were not covered by the manufacturer’s information, you have the right to pursue legal action and recover compensation to help pay for the losses that you experienced as a result. These lawsuits can cover everything from additional medical expenses to the pain and suffering that you endured.
Trust Shapiro Legal Group, PLLC with Your Medication Injury Claims
If you or a loved one has suffered harm from a prescription medication, Shapiro Legal Group, PLLC can help you pursue a claim and secure the settlement that you deserve. For years, we have held large manufacturers accountable for their dangerous drugs and know what it takes to recover maximum compensation for patients. Contact us today at (800) 220-0984 for a free consultation and discuss your case with a defective drug lawsuit attorney.