A Food and Drug Administration panel of health experts unanimously voted for the approval of Optimer Pharmaceutical's antibiotic, which fights Clostridium difficile infections in patients, according to a Bloomberg Businessweek news report.
The FDA panel, in a 13-0 vote, agreed the drug fidaxomicin was safe and effective in treating C. diff. However, there was disagreement among the panelists over whether the drug was able to prevent infections in the future, according to the news report. The panelists also said the drug should include a warning label mentioning potential risks to patients who are pregnant or have weak immune systems, according to the news report.
Despite the panel's unanimous backing, the FDA is not obligated to fully approve the drug. The FDA is expected to make a decision about the drug's final clearance by May 30.
Read the news report about Optimer's drug fidaxomicin.
Read other coverage about C. diff.:
- Previous Health Facility Contact a Risk Factor for C. Diff Infection
- 6 Common Misconceptions About Surgery Center Sterilization
- Hines VA CDI Severity Score Index Shows Strongest Correlation for Predicting Severe C. Diff Cases
The FDA panel, in a 13-0 vote, agreed the drug fidaxomicin was safe and effective in treating C. diff. However, there was disagreement among the panelists over whether the drug was able to prevent infections in the future, according to the news report. The panelists also said the drug should include a warning label mentioning potential risks to patients who are pregnant or have weak immune systems, according to the news report.
Despite the panel's unanimous backing, the FDA is not obligated to fully approve the drug. The FDA is expected to make a decision about the drug's final clearance by May 30.
Read the news report about Optimer's drug fidaxomicin.
Read other coverage about C. diff.:
- Previous Health Facility Contact a Risk Factor for C. Diff Infection
- 6 Common Misconceptions About Surgery Center Sterilization
- Hines VA CDI Severity Score Index Shows Strongest Correlation for Predicting Severe C. Diff Cases
