Health trends

Risperdal (risperidone) and Risperidone: Recall

Ortho-McNeil-Janssen Pharmaceuticals notified health-care professionals and the public of a recall of specific lots of Risperdal (risperidone) 3mg tablets and risperidone 2mg tablets. The recall stems from consumer reports of an uncharacteristic odour thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

The Risperdal lot 0GG904 - which includes approximately 16,000 bottles - was shipped between 8/27/2010 and 2/15/2011. The company believes there are approximately 1,600 bottles of Risperdal from this lot remaining in the marketplace. The risperidone lot OIG175 - which includes approximately 24,000 bottles - was shipped between 11/10/2010 and 1/01/2011. The company believes there are fewer than 1,200 bottles of risperidone from this lot remaining in the marketplace. Risperdal (risperidone) is used for the treatment of schizophrenia in adults and adolescents ages 13-17 years as well as bipolar mania and irritability associated with autistic disorder.

- Source: US Food and Drug Administration

Generic antibiotic approved

The US Food and Drug Administration recently approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people ages 18 and older. Generic tablet, oral solution, and injectable solution dosage forms of levofloxacin have been approved.

Levofloxacin is used to treat mild, moderate, or severe bacterial infections of the skin, sinuses, kidneys, bladder, and prostate caused by specific germs. It also is used to treat certain bacterial infections that cause bronchitis or pneumonia, and to treat those exposed to inhalational anthrax.

"Generic drugs are important options that allow greater access to health care for Americans," said Keith Webber, PhD, deputy director, Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research. "FDA-approved generic drugs must meet rigorous standards and are required to be of high quality so that people can be assured that their medications will act the same in the body as the brand-name product."

- Source: US Food and Drug Administration