“Black Box” Warning Added to Popular Antibiotic

Dangerous drug lawyers at Pintas & Mullins Law Firm know through extensive experience that a black box warning clearly indicates that a medication is inherently and excessively dangerous. Black box warnings are added to drug labels by the FDA when there is clear, scientific evidence that the drug poses a significant health risk or can cause life-threatening side effects. Black box labels are the most severe type of warning medications can have, and are named as such because of the black border that surrounds the text of the warning.

Tygacil (tigecycline) is one of the most recent drugs to have a black box warning added to its labels. This medication enters the body through and IV, and is used to treat bacterial infections, such as commonly-acquired pneumonia and skin infections. The issues surrounding this drug are particularly severe: recent studies have suggested that there is a significantly elevated risk of death in patients prescribed to Tygacil.

Increased Mortality Risk

In September 2010, the FDA was made aware of the problems with Tygacil and immediately issued a Drug Safety Communication, which can be viewed here. This announcement confirmed that, according to a group of clinical trials, Tygacil actually progressed infections in certain patients, resulting in excessive deaths.

The increased risk of death was most pronounced in patients being treated for hospital-acquired pneumonia and particularly ventilator-associated pneumonia. Excessive deaths were also seen in patients being treated for diabetic foot infections, however, Tygacil is not approved for any of these three ailments (it is only approved to treat commonly-acquired pneumonia), which begs the question of why physicians were prescribing it in the first place.

There were 13 separate clinical trials from which these results were taken. Mortality rates in patients treated with Tygacil were numerically higher for every infection, sometimes significantly higher. The FDA notes that Tygacil may be at some disadvantage compared to other antibiotics, particularly for infections like hospital-acquired pneumonia.

The Decline of Antibiotics

Antibiotics are one of the most important discoveries in medical history, however, bacteria have increasingly adapted to resist the medicines and progress in the body. This is a recent phenomenon, and one that has many medical experts concerned that antibiotics may soon be rendered ineffective. FRONTLINE recently spoke to an associate director at the Centers for Disease Control and Prevention (CDC) about the problems of antibacterial resistance and how to combat it.

The CDC director affirmed that bacterial resistance is in fact inevitable as a naturally-occurring phenomenon. He further noted that the overuse and misuse of antibiotics has fueled the resistance, leading to excessive deaths from progressed infection. As a result, physicians are running out of medicines to treat illnesses that were previously easy to cure, which perhaps explains why doctors were prescribing Tygacil for strains of pneumonia and foot infections it was not approved for.

Using any pharmaceutical or medical device for uses not approved by the FDA can be grounds for a medical malpractice lawsuit if it seriously injures or kills the patient. The CDC director stated that many physicians are now forced to use antibiotics, such as Tygacil or Colistin, despite knowing they are excessively dangerous, because the patient demonstrates resistance to other, safer antibacterial drugs.

If you or a loved one passed away after taking Tygacil you may be entitled to compensation through a wrongful death lawsuit. Drug injury attorneys at Pintas & Mullins Law Firm understand how difficult it can be to make this decision while mourning the loss of a loved one, and are here to guide you through each step of the process. We have been working with victims of dangerous pharmaceuticals for over two decades, and always offer free legal consultations.


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