FDA asks Baxter Healthcare to recall, destroy volumetric infusion pumps
SILVER SPRING, Md. The Food and Drug Administration is ordering medical supply manufacturer Baxter Healthcare to recall and destroy all of its Colleague volumetric infusion pumps, citing various safety issues, the agency said Monday.
The FDA said the order was based on a “longstanding failure to correct many serious problems” with the Colleague pumps and said the Deerfield, Ill.-based company would have to replace the recalled pumps at no cost to customers. The pumps are widely used in hospitals, clinics and in home health care, and the agency thinks there may be as many as 200,000 currently in use.
The agency said it has been working with Baxter since 1999 on “numerous” device flaws and since then, Colleague pumps have been subject to numerous recalls due to battery swelling, inadvertent power off, service data errors and other issues. In June 2006, the FDA obtained a consent decree of permanent injunction that forbade Baxter to manufacture or distribute the pumps until it corrected the manufacturing problems and brought the pumps into compliance. In April of this year, Baxter told the FDA that it did not plan to begin correcting the pumps until May 2012, with completion accepted in 2013, a proposal the FDA called “unacceptable.”
Baxter issued a statement Monday saying that it would comply with the recall, which it estimated would cost between $400 million and $600 million.
“Baxter will work with the FDA to ensure that the recall process provides customers appropriate alternatives for supporting patients’ needs,” the company statement read.
BioSante to re-initiate prostate cancer vaccine program
LINCOLNSHIRE, Ill. Drug maker BioSante Pharmaceuticals has restarted a development program for a prostate cancer vaccine, the company said Monday.
The company announced plans to begin treating prostate cancer patients using the GVAX Prostate vaccine in a phase 2 clinical trial at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center beginning in fourth quarter 2010.
“We have worked with GVAX Prostate Cancer Vaccine for several years and believe there is a great potential to develop a treatment regimen that will be a significant benefit to men who suffer with prostate cancer,” Johns Hopkins associate professor Charles Drake said in a statement on behalf of BioSante.
The news comes days after the Food and Drug Administration approved Dendreon Corp.’s prostate cancer vaccine Provenge (sipuleucel-T), which works by modifying the patient’s own immune cells.
Stater Bros. announces prenatal vitamin offering for mothers-to-be
SAN BERNARDINO, Calif. A Southern California supermarket chain is offering free prenatal vitamins to expectant mothers this month.
In line with Pregnancy Awareness Month, Stater Bros.’ said its Super Rx Pharmacy will offer prenatal vitamins to those with a doctor’s prescription. Quantities must be written for a thirty-day supply and not to exceed 30 tablets. The free prenatal vitamin program will feature the generic version of these well-known brands:
- Advanced Natal Care
- Natal Care Glosstabs
- Nata Tab Rx
- Natal Care Plus
- Ultra Natal Care
This initiative is one of several Stater Bros. has offered its customers. The supermarket chain also offers a free antibiotic program and $4 generic prescription drug program.
“Stater Bros. remains committed to the health and well-being of our valued customers,” stated Jack Brown, Stater Bros. chairman and CEO. “As the only supermarket chain in Southern California to offer this program free of charge, Stater Bros. is proud to promote the health of mothers-to-be while easing some of the economic burden that many of our valued customers are facing.”