The FDA required a Black Box Warning to be added to the Tygacil® label to inform doctors and consumers of the increased risk of death associated with use of the IV antibiotic drug.
St. Louis, Missouri (PRWEB) October 11, 2013
The Pharmaceuticals and Medical Litigation Department at Schlichter, Bogard & Denton, LLP are investigating the new FDA-released safety concerns surrounding Pfizer’s antibiotic drug Tygacil® and providing free legal consultations to victims of Tygacil® induced injury cases in all 50 states. If your loved one used the IV antibacterial Tygacil® and suffered death as a result, please contact the law firm of Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 or visit our website for your free, confidential and no-obligation consultation.
On September 27, 2013, the FDA issued a Drug Safety Announcement warning that “an additional analysis shows an increased risk of death when intravenous (IV) Tygacil® (tigecycline) is used for FDA-approved uses as well as non-approved uses.” As a result, the FDA required a Black Box Warning to be added to the Tygacil® label to inform doctors and consumers of the increased risk of death associated with use of the drug. The FDA noted that a Black Box Warning is the strongest and most serious type of warning within any drug’s label.
Tygacil® is an intravenous (IV) antibiotic drug manufactured by Pfizer, Inc and introduced to the United States market in June 2005. The IV antibacterial Tygacil® was approved as a treatment for skin complications and infections, as well as community-acquired bacterial pneumonia. On September 27, 2013, NBC News reported that Pfizer reported $335 million in Tygacil® revenue last year, including $152 million in sales within the United States.
History of Safety Concerns
In September 2010, the FDA issued a similar Drug Safety Announcement regarding the increased risk of death associated with Tygacil®. The Drug Safety Communication was issued based on the fact that a meta-analysis of 13 Phase 3 and 4 trials concluded that patients receiving Tygacil® have an increased risk of death in comparison to patients receiving other antibacterial drugs. In particular, death occurred in 4% of the patients receiving Tygacil®, in comparison to 3% of the patients receiving other antibacterial drugs. The increased risk of death was highest in patients treated with Tygacil® for ventilator-associated pneumonia – a use that is not FDA approved.
On October 26, 2011, Public Citizen (a national, nonprofit consumer advocacy organization) petitioned the FDA to require the addition of a Black Box Warning to the label for Tygacil® indicating that the antibiotic “has an increased risk of death in comparison to many other antibiotics when used to treat a variety of serious infections and should be used only as a last-resort antibiotic in the treatment of serious infections, and then only in combination with one or more bactericidal antibiotics.” On May 15, 2012, Public Citizen submitted additional data to the FDA in support of its October 2011 petition for the FDA to immediately require the addition of a Black Box Warning.
Black Box Warning of IV Antibiotic Tygacil®
Although the FDA is not clear why the IV antibacterial Tygacil® is associated with a higher risk of death in comparison to other antibiotic drugs, the FDA required the addition of a Black Box Warning regarding the increased mortality risk of IV Tygacil® on September 23, 2013. In particular, the decision to add the Black Box Warning to the Tygacil® label was based on additional analyses performed after the FDA’s issuance of the September 2010 Drug Safety Announcement. In particular, the FDA analyzed data from 10 clinical trials conducted only for FDA-approved uses of Tygacil®, which included trials conducted after the approval of Tygacil®. The FDA concluded that the data demonstrated an increased risk of death among patients receiving Tygacil® in comparison to patients receiving other antibacterial drugs. Specifically, death occurred in 2.5% of patients receiving Tygacil®, in comparison to 1.8% of patients receiving other antibacterial drugs.
The FDA now warns that “[h]ealth care professionals should reserve Tygacil® for use in situations when alternative treatments are not suitable. Tygacil® is FDA-approved to treat complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia. Tygacil® is not indicated for treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia.”
The new Black Box Warning contained within the Tygacil® label provides as follows: “All-cause mortality was higher in patients treated with TYGACIL® than comparators in a meta-analysis of clinical trials. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. TYGACIL® should be reserved for use in situations when alternative treatments are not suitable.…”
About Schlichter, Bogard & Denton, LLP
Schlichter, Bogard & Denton, LLP is a unique law firm that aggressively represents victims of dangerous pharmaceutical medications and unsafe medical devices. With hard work, creative thinking, and strong trial skills, we have earned an outstanding nationwide reputation by representing thousands of individuals who have suffered serious injuries or death as a result of dangerous pharmaceutical drugs and medical devices. If your loved one died after using the IV antibacterial Tygacil®, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.
The choice of a lawyer is an important decision and should not be based solely on advertisements.