2013-09-28 - Tycacil LabelToday, the FDA issued a Drug Safety Communication and approved a new Black Box Warning for Tygacil (tigecycline), warning that the IV antibacterial increases deaths in instances of approved as well as non-approved uses.  A Black Box Warning is the strongest warning given to a drug.  The FDA reiterated that Tygacil should only be used as a last resort, especially in patients with severe infections.

Tygacil, manufactured by Wyeth/Pfizer is a drug used to treat pneumonia, Staph infections, MRSA, and complicated intra-abdominal infections—serious infections requiring “source control,” or invasive procedures that “attack” the affected organ or area as the source of infection.  Source control may be accomplished by draining, device removal, or debridement.  This speeds treatment before antibiotics can be administered.

Tygacil is used in these cases because it is a glycylcycline, which, unlike other antibiotics, inhibits the growth of bacteria rather than killing it directly to reduce instances of drug-resistant bacteriaTygacil is also effective against a wide spectrum of bacteria.

Tygacil was first approved by the FDA in 2005, where it was fast-tracked through the 505(b) process because it was effective at treating Staph infections and MRSA. However, in September 2010, the FDA issued a warning that Tygacil may increase rates of death and should only be used as a last resort.  In pooled studies, Tygacil was shown to increase mortality—particularly in cases where Tygacil was used to treat ventilator-associated pneumonia and diabetic foot infection, both unapproved uses of Tygacil.

Although it may be difficult to show that Tygacil was the actual cause of death, clinical pools consistently showed higher rates of mortality than other antibiotic medications.

We encourage patients and loved ones who have been affected by the approved or unapproved use of Tygacil to treat MRSA, pneumonia, ventilator-associated pneumonia, diabetic infection, Staph infection, or another microbial infection to contact us for a free case evaluation at www.andrewsthornton.com or toll free at 1-800-644-1734.

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