FDA Warns Tygacil Antibiotic Increases Risk of Death
By Robert J. Boumis
On September 27, the U.S. Food and Drug Administration (FDA) issued a statement warning that the drug Tygacil (tigecycline) was linked to a greatly increased risk of death. This followed up a 2010 Drug Safety Communication regarding reports of similar Tygacil side effects.
Tygacil was a relatively-recently approved antibiotic. It is designed to work against a wide variety of both gram-negative and gram-positive bacteria, an unusual capability for an antibiotic. The drug was designed to help combat antibiotic-resistant drugs, a growing concern as many common bacteria have evolved resistances to more common antibiotics.
The FDA’s statement came at the same time they updated the drug’s warning information to include a Black Box Warning. A Black Box Warning is the highest level of safety warning the FDA can require a drug manufacturer to issue, and signifies that the drug has a significant risk of serious or life-threatening side effects. These warnings are reserved for the most serious drug warnings the FDA issues, short of an actual drug recall.
The FDA’s statement indicated that an analysis found that patients who received Tygacil experienced an increased risk of death, even when other risk factors were considered. According to the FDA’s statement, the specifics usually included a worsening of infection of other medical underlying medical conditions. However, these complications arose more often with this drug than they did with other antibiotic treatments under similar conditions. Additionally, there have been reports of Tygacil side effects such as liver failure, Stevens Johnson Syndrome, pancreatitis and other serious complications.
Drug injury lawsuits have been filed against the manufacturers of Tygacil. These Tygacil lawsuits allege that the manufacturers were aware or reasonably should have been aware of the serious risks associated with their drug. The Tygacil injury lawsuits further allege that the manufacturers no only failed to act on the information in a timely manner, but may have actively concealed the risks, preventing patients and their prescribing physicians from having all of the information they needed to make an informed medical decision.
The FDA’s latest statement on the drug recommended that health care professionals only use Tygacil in situations where other treatments are not working or otherwise not suitable for patients.
Obtain a Free Tygacil Lawsuit Review
If you, or someone you care about, took Tygacil and went on to suffer from serious medical complications, you’ve probably found yourself facing a stressful situation. The loss of a loved one carries with it many challenges. Next of kin and other survivors often find themselves facing not only the financial burden of such a situation, but also financial strain, like medical expenses, final expenses, and lost income potential.
When facing challenges like this, it’s normal to feel overwhelmed. But you need to remember that you still have rights, and there are steps that you can take to regain a measure of control over your situation. You can start by visiting the Tygacil (Tigecycline) Class Action Lawsuit Investigation and obtaining a free evaluation of your case. You may qualify to seek compensation through a Tygacil lawsuit or class action lawsuit.
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