New TB drug gets approval amid side effect concerns
A new TB (tuberculosis) drug has been approved by the Food and Drug Administration, but there are concerns about side effects. A study published in the Lancet reveals that some medical experts would prefer to see more research before the new TB medication is widely used. The Community Research Advisors Group (CRAG) mentions that bedaquiline must be tested on more people.
Bedaquiline offers promise for treating TB
TB often requires a long and difficult treatment process, and multi-drug resistant tuberculosis (MDR-TB) has made finding an effective drug for the condition a challenge. However, bedaquiline has shown promise as a possible treatment for MDR-TB, and the FDA appears to be pleased with the progress of the previous clinical trials.
Side effects that must be considered
The Community Research Advisors Group is concerned about the FDA’s decision to fast-track the new TB drug and would prefer more clinical trials. The group points out that there are several side effects that must be considered and studied in more depth before using the medication on patients. The risks include liver damage and heart rhythm problems.
CRAG mentions a disturbing clinical trial that the group would prefer to have more information about and a better explanation of the risks involved with the drug. In one trial, the bedaquiline group was more likely to die than the placebo group. Although the trial had ended before researchers could determine their exact cause of death, it raises important issues that must be explored before putting the drug on the market.
It is estimated that TB kills 1.5 million people a year with an estimated 8 million new cases a year. A new medication to treat this disease would be a powerful addition to the current options, but experts recommend that side effects be explored in depth before lives are put at risk.
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