US Pharm. 2007;32(5)62.
FDA Moves to Stop Marketing of Nausea and Vomiting Drug
The FDA announced that companies must cease manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride. Drugs in suppository form containing trimethobenzamide, marketed under such brand names as Tigan, Tebamide, T-Glen, Trimazide, and Trimethobenz, says FDA, do not show evidence of effectiveness.
The agency recommends that patients using suppositories with trimethobenzamide or who have questions or concerns contact their health care provider. Many approved drugs, FDA points out, available in a variety of forms, effectively treat nausea and vomiting.
FDA Requests Stronger Warnings for Sleep Disorder Drugs
The FDA requested that makers of sedative-hypnotic sleep disorder drugs strengthen their product labeling to include strong language of potential risks. These include severe allergic reactions and sleep driving, characterized by driving while not fully awake, as well as other complex behaviors such as eating and making phone calls while not fully awake.
In addition to the warnings, the FDA requested that manufacturers of sleep disorder drugs develop Patient Medication Guides-- handouts given to patients, families, and caregivers when the drugs are dispensed. The FDA also asked the manufacturers to send letters to health care providers notifying them of the new warnings. Also, to learn how often sleep driving and other complex behaviors occur with sleep disorder drug use, FDA recommended that manufacturers carry out clinical trials.
Joint Report Out on Spinach Outbreak
Following an inquiry into the Fall 2006 E coli outbreak, the FDA and California's Department of Health Services jointly released a report on the incident. The contamination of the Dole brand Baby Spinach, sold in bags, caused 205 illnesses and three deaths.
Using product codes and employing DNA fingerprinting from the bags, investigators pinpointed the source of the outbreak to a single field. They cited the presence of wild pigs, proximity to irrigation wells, and surface waterways exposed feces from cattle and wildlife as potential environmental risk factors for E coli contamination.
FDA pointed out that although washing would not have prevented the outbreak, the practice does reduce the risk from other contaminants.
Agreement on Stronger Anemia Drug Warnings
Following clinical study results, FDA and drug makers agreed on strengthened safety information for erythropoiesis-stimulating agents (ESAs) used for anemia treatment. Changes to the labels include updated warnings, a new boxed warning, and dosing instruction modifications. In studies, ESAs administered at higher-than-recommended doses indicated an increased risk of death, blood clots, strokes, and heart attacks in chronic kidney failure patients. At recommended doses, the trials reported an increased risk of death in cancer patients who were not receiving chemotherapy and a greater risk of blood clots in postorthopedic surgery patients.
The drugs affected by the safety update are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). FDA said that more label revisions to ESA drugs were possible following a meeting this month.
To comment on this article, contact firstname.lastname@example.org.