FDA Warns Public of Deadly Tygacil (Tigecycline) Side Effects
By Amanda Antell
Pfizer’s antibacterial drug Tygacil (tigecycline) is facing legal scrutiny following the FDA’s recent announcement that the company must place a Black Box Warning on the drug’s label. Black Box Warnings are reserved only for drugs whose side effects can lead to death. Additionally, the FDA said that Tygacil should only be used as an alternative treatment when other options are not available.
Tygacil is an intravenous drug approved to treat complicated skin infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia. It is also used off-label for the treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia. It has been linked to fatal liver damage, acute pancreatitis, Stevens Johnson Syndrome, and more.
The FDA said that the risk of death from Tygacil side effects is more likely in patients with hospital-acquired pneumonia and other types of infections. FDA investigations found that Tygacil has a higher risk of death compared to many similar skin antibacterial drugs in the United States, with a 2.5% greater risk compared to the standard 1.8% chance occurrence.
Pfizer Spokeswoman Kimberly Bencker issued a public statement regarding the FDA’s Tygacil Black Box Warning: “Due to the increase in antibiotic resistance worldwide, Tygacil continues to be an appropriate treatment option for its approved indications.”
At this time, Pfizer acknowledges the risks of Tygacil side effects and is willingly compliant with the FDA’s Black Box Warning requirement for the drug. While many are relieved that this intravenous drug now has the appropriate labeling, it came too little too late for some patients, who have allegedly suffered serious side effects such as acute pancreatitis, Stevens Johnson Syndrome and fatal liver damage.
At this time, Pfizer is facing a potential class action lawsuit as part of an investigation into claims the company committed negligence, false advertising, concealment of information, and misrepresentation of a product.
Overview of Tygacil Side Effects
Tygacil (tigecycline) is manufactured by Pfizer and was approved by the FDA in 2005 to treat complicated skin and abdominal infections, as well as community-acquired bacterial pneumonia. On September 23, 2013, the FDA required the company to place a Black Box Warning on the drug’s label, indicating that fatal side effects could occur from Tygacil.
Tygacil is the first drug available in the United States that is part of a new antibiotic family called glycylcyclines. These antibiotics inhibit bacterial growth rather than killing it, which eventually causes the invasive cells to die out because they cannot reproduce. Due to the unique chemical structure of Tygacil, it is effective against a broad spectrum bacteria, making it less vulnerable to resistant bacteria. Unfortunately, its Tygacil’s design and mechanism that have many medical experts suspecting that is causing death amongst patients.
While it is unknown as to what exactly is causing such reactions amongst some patients, the concern remains that Tygacil still may cause death to patients. Other side effects of Tygacil include but are not limited to:
- Liver failure
- Pancreatitis
- Stevens Johnson Syndrome (SJS)
- Toxic Epidermal Necrolysis (TEN)
Obtain a Free Tygacil Injury Lawsuit Review
If you believe that you or a loved one has been the victim of an injury from Tygacil side effects, you have legal options. Please visit the Tygacil (Tigecycline) Class Action Lawsuit Investigation. There, you can submit your claim for a free legal review and if it qualifies for legal action, a seasoned Tygacil lawyer will contact you for a free, no-obligation consultation. You will be guided through the litigation process at no out-of-pocket expenses or hidden fees. The Tygacil injury lawyers working this investigation do not get paid until you do.
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