Texas Tygacil Lawyer

June 6, 2012 — Public Citizen, a Washington D.C.-based consumer advocacy group, has updated their petition from October of 2011 which called for a “Black Box” warning on the label of the antibiotic drug Tygacil (tigecycline). The group wants the FDA to place stronger warnings that the drug is associated with a higher risk of death than some other antibiotics. The updated petition includes the result of a new clinical study that adds more evidence to support the link between Tygacil and a higher risk of death.

 

Public Citizen has been calling for a “Black Box” warning since October of 2011. The Black Box is the strongest warning that the FDA can place on a drug label, and it is usually reserved for life-threatening side effects. Since then, a new scientific study has been published linking Tygacil to an increased risk of death.

The study compared Tygacil to other antibiotics, and found Tygacil increased the risk of mortality by 0.7%, and increased the non-cure rate by 2.9%. In real numbers, Public Citizen says that this means one extra person dies per 143 patients, and one extra patient is not cured for every 34 patients who are treated with Tygacil instead of a different type of antibiotic.

The group is concerned that doctors will prescribe Tygacil instead of safer, equally effective alternative antibiotics. Therefore, they are calling on doctors to only use Tygacil when other antibiotics have failed. Furthermore, it may be best to prescribe it in combination with other antibiotics.

According to Public Citizen, there is not enough awareness about the risks of Tygacil. In addition to the Black Box, they want manufacturers of Tygacil to send a “Dear Doctor” letter, which is a standard way that drug companies communicate drug risks to physicians.

The FDA has already warned about the higher mortality rate associated with Tygacil, and they have specifically warned against using Tygacil off-label in patients with ventilator-acquired pneumonia. In one study, 20% of these patients died, compared to 12% of patients who were given other antibiotics.

Tygacil (tigecycline) is an antibiotic that was approved by the FDA in 2005 for the treatment of complex skin infections, abdominal infections, and community-acquired pneumonia. It was invented by the drug company Wyeth, which is now a subsidiary company of Pfizer, Inc.

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