Wyeth Receives Approvable Letter from FDA for TYGACIL for the Treatment of Patients with Community-Acquired...(GACIL is contraindicated in patients wit...),Health

tigecycline

-- TYGACIL should be administered with caution in patients with known

hypersensitivity to tetracycline class antibiotics

-- Glycylcycline class antibiotics are structurally similar to

tetracycline class antibiotics and may have similar adverse effects.

Such effects may include: photosensitivity, pseudotumor cerebri, and

anti-anabolic action (which has led to increased BUN, azotemia,

acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis

has been reported with the use of TYGACIL

-- The safety and efficacy of TYGACIL in patients with hospital-acquired

pneumonia have not been established

-- In clinical trials, the most common treatment-emergent adverse events

in patients treated with TYGACIL were nausea (26.4%) and vomiting

(18.1%)

-- TYGACIL may cause fetal harm when administered to a pregnant

woman

-- The safety and effectiveness of TYGACIL in patients below age 18 and

lactating women have not been established

-- Clostridium difficile-associated diarrhea (CDAD) has been reported with

use of nearly all antibacterial agents, including TYGACIL, and may

range in severity from mild diarrhea to fatal colitis

-- Concurrent use of antibacterial drugs with oral contraceptives may

render oral contraceptives less effective

-- The use of TYGACIL during tooth development may cause permanent

discoloration of the teeth. TYGACIL should not be used during tooth

development unless other drugs are not likely to be effective or are

contraindicated

-- Prothrombin time or other suitable anticoagulant test should be

monitored if TYGACIL is administered with warfarin

-- Monotherapy should be used with caution in patients with clinically

apparent intestinal
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