FDA Says New Tygacil Antibiotic Has Increased Risk of Death
By Robert J. Boumis
Antibiotic resistance is a major concern in modern medicine. In this phenomenon, bacteria rapidly adapt to the presence of antibiotics, evolving coping mechanisms that can render our miracle drugs worthless. The increase of antibiotic-resistant bacteria has spurred the development of new antibiotics like Tygacil, which is manufactured by Pfizer Inc. However, Tygacil does carry risks of its own, even when compared against existing antibiotics.
Tygacil is a newer antibiotic specifically developed to give healthcare professionals a new weapon against drug-resistant bacteria. It belongs to an entirely new class of antibiotics, structurally and functionally different from existing drugs. However, it does have some structural similarities with tetracycline antibiotics like minocycline. Tygacil works by interfering with protein synthesis by acting on cellular machinery bacteria use to produce proteins. Tygacil is different enough from existing antibiotics that bacteria resistant to other drugs can still be treated with Tygacil.
In early September 2013, the U.S. Food & Drug Administration (FDA) took several steps to warn consumers about an increased risk of death associated with Tygacil. First, the FDA issued a Drug Safety Communication, directed to critical care medical personnel and pharmacists. This communication explained that analysis suggested patients taking Tygacil had an increased risk of death compared to patients on other antibiotics. The analysis controlled for other factors, including how sick the patient was prior to treatment. Despite controlling for certain factors, researchers still found an increased risk of death associated with the new antibiotic.
Later that month, the FDA mandated changes in the drug’s labeling to reflect an increased risk of death in patients using Tygacil. The updated labeling advised physicians to reserve the drug for situations when alternative treatments are not suitable.
A class action lawsuit investigation has been launched against Pfizer Inc. A Tygacil lawsuit could allege that the manufacturers were aware – or reasonably should have been aware – of the risk of serious health risks linked to this drug. Drug manufacturers are legally obligated to thoroughly test their drugs for safety and monitor postmarket reports and journal articles for signs of problems. Additionally, a Tygacil lawsuit could further allege that manufacturers were aware of these risks and deliberately downplayed or concealed them, preventing patients and healthcare professionals from having the information they needed to make informed medical decisions.
If someone you love died after using Tygacil, you have almost certainly been through a trying ordeal. The sudden loss of a loved one can take an enormous emotional toll. In addition to the emotional strain, surviving family members often face substantial financial challenges, including medical bills, final expenses and lost income potential. Under these circumstances, it’s normal to feel depressed and overwhelmed. But you need to remember that regardless of the situation you’ve found yourself facing, 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. Here, you can enter information bout your situation for a legal review by a trained expert with a background in this type of litigation. The initial consultation is completely free of charge and from here, you can receive additional guidance on the best steps to take in your exact situation.
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