ABBOTT WITHDRAWS TEMAFLOXACIN

Abbott Laboratories has said that it will voluntarily withdraw its new quinolone antibiotic temafloxacin from all its world markets because of an "unexpected profile and incidence of adverse reactions." The product was recently approved by the US Food and Drug Administration for the treatment of respiratory, skin, prostate and urinary tract infections, and is also marketed in Italy, the UK, Germany, Ireland, Sweden and Argentina.

Although Abbott is to carry out the withdrawal voluntarily, it appears that the FDA had already notified regulatory authorities in Europe of its concerns about the safety of the drug, after coming to a decision itself that the drug should be withdrawn. The decision stemmed from some 50 cases of adverse reactions, including three deaths, that occurred in patients who received temafloxacin.

According to the FDA, these reactions included cases of severe low blood sugar, especially in the elderly. There were also a number of cases of an unusual complex involving hemolytic anemia and other blood cell abnormalities, as well as cases of respiratory distress and hepatic and renal dysfunctions. Some of the reactions were reported from outside the USA. Of these side effects, only renal impairment is mentioned in the labeling for the drug.