The U.S. Food and Drug Administration (FDA) is warning the public that the antibiotic doripenem—sold under the brand name Doribax—might increase the risk of death compared to other, similar drugs.
What Is Doribax and What Is It Prescribed For?
Doribax is a member of the carbapenem class of antibiotics. It interferes with certain bacterias’ cell wall formation processes. The Japanese pharmaceutical company, Shionogi, Inc., makes Doribax. The FDA approved it in October 2007 in the form of an intravenous injection. It can be used to treat complicated intra-abdominal infections (like pneumonia) and complicated urinary tract infections, including pyelonephritis (kidney inflammation).
According to the FDA’s drug safety communication, which was issued on March 6, 2013, a clinical trial showed that Doribax carried an increased likelihood of death and lower cure rates compared to other drugs when used in patients on ventilators who develop pneumonia. The three-year clinical trial was stopped in 2011 when researchers determined that two other antibiotics, imipenem and cilastatin, were safer and more effective. The agency approved changes to Doribax’s label explaining these risks and advised that Doribax is not approved to treat pneumonia to patients on ventilators. It is still considered safe for its on-label treatments, though.
The label-change also included a new entry in the “warnings and precautions” section advising that patients with preexisting central nervous system disorders were at a higher risk of developing seizures than previously known.
How Can a Lawsuit Help Me?
If you or a loved one took Doribax while on a ventilator, and you believe it caused a deadly injury or seizure, then a lawsuit can help you hold the manufacturer accountable. The amount of compensation from a Doribax lawsuit can include damages for full medical expenses, lost earnings, pain and suffering, and other damages. For a free, confidential legal consultation with a lawyer from the Rottenstein Law Group, click on this link or call 1 (888) 976-8529. RLG will keep you up to date on any Doribax class action lawsuits, additional FDA Doribax warnings, and Doribax FDA recall announcements. If you or a loved one has taken Doribax, and you believe it caused an injury, contact RLG today.