MedWatch Alert Issued for Trecator-SC Reformulation
Wyeth Pharmacueticals has reformulated and renamed its tuberculosis treatment, Trecator-SC, the FDA said in a recent MedWatch alert.
The drug, which is now named Trecator (ethionamide tablets, USP), has been reformulated to include a film coating rather than a sugarcoating, the FDA said.
In a letter sent to healthcare providers and pharmacists, Wyeth warned that patients' bodies will absorb the new film-coated tablet more rapidly than the previous sugarcoated tablet, resulting in higher peak concentrations of ethionamide. As a result, some patients might become intolerant when the same initial dose is used as with the old sugarcoated tablet.
Trecator is indicated as a combination treatment with other antituberculous drugs for the treatment of patients with active M. tuberculosis that is resistant to isoniazid or rifampin, or when the patients show intolerance to other drugs.
To view the MedWatch alert, go to http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Trecator (http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Trecator).