Oral antibiotic withdrawn for safety reasons

By Alison Hsiao  /  Staff reporter

Tue, Feb 25, 2014 - Page 3

Oral forms of chloramphenicol, an antibiotic, were formally withdrawn from Taiwan’s market starting yesterday, the Food and Drug Administration (FDA) said.

The agency said that compared with oral forms of chloramphenicol, which carries the risk of causing bone marrow suppression, safer substitutes now exist.

In addition, orally administered chloramphenicol is considered redundant because chloramphenicol injections, are now used for patients with serious infections, the agency said.

There are 66 approved drugs containing chloramphenicol, 36 of which were administered orally, the agency said.

Chloramphenicol is a broad-spectrum antibiotic, which means it is effective against infections caused by a wide variety of bacteria, and it inhibits bacterial protein synthesis, the agency said.

The agency’s anulment of the antibiotic’s permit comes after recent study results showed that the antibiotic is associated with the risks of hematologic toxicity and bone marrow suppression.

However, the benefits of the chloramphenicol injection for people who suffer drug-resistant bacterial infections still outweigh its risks, the agency said, and its continued clinical use has been approved.

It also works better at penetrating the central nervous system (CNS), an attribute that is needed for treating CNS infections.

Other forms of the antibiotic, such as eye drops, ear drops and suppositories, have also been permitted to be used clinically, said the health authority, as their therapeutic effects outweigh their relatively low health risks.

The US removed the oral form of chloramphenicol from its market in July 2012, the agency said.