Skip to main content

Injectable Boniva in Short Supply, FDA Says


WASHINGTON (Reuters) Jun 07 - Clinicians seeking to replenish their supply of injectable ibandronate (Boniva) in the next few weeks may be out of luck because the company did not accurately forecast demand, federal officials said.
A mismatch between company forecasts and actual demand is one of the many reasons medicines can go into shortage, especially when there is only one company making them.
The number of cancer, anesthetic and other drugs in short supply in the United States hit a record high last year with 250 medicines, largely due to manufacturing problems.
The Boniva shortage does not affect the more widely used oral version of the drug which became available generically earlier this year.
Genentech, the Roche unit that makes Boniva, used to prevent and treat osteoporosis, could not immediately say why demand forecasts for injectable Boniva were not accurate.
"Patient safety is of the utmost importance to Genentech, and we are working as fast as we can to address the temporary stock out of Boniva injection," said Christopher Vancheri, Genentech spokesman. He said the company expects to resume shipments of the single-use syringes in mid to late June.
The U.S. Food and Drug Administration announced the shortage of Boniva vials on its website late on Wednesday.
At least five companies recently got FDA permission to sell generic versions of Boniva tablets, including Mylan Pharmaceuticals Inc, Watson Pharmaceuticals Inc and Indian drugmaker Dr Reddy's Laboratories.
An estimated 10 million Americans over the age of 50 have osteoporosis, and another 34 million have low bone mass, according to the National Osteoporosis Foundation.

Comments

Post a Comment

Popular posts from this blog

Contact Precautions May Have Unintended Consequences

Contact precautions, including gloves, gowns, and isolated rooms, have helped stem the transmission of hospital pathogens but have also had some negative consequences, according to findings from a new study. Healthcare worker (HCWs) visited patients on contact precautions less frequently than other patients and spent less time with those patients when they did visit, report Daniel J. Morgan, MD, from the University of Maryland School of Medicine and the Veterans Affairs (VA) Maryland Health Care System, Baltimore, and colleagues. Moreover, patients on contact precautions also received fewer outside visitors. "Less contact with HCWs suggests that other unintended consequences of contact precautions still exist," Dr. Morgan and coauthors write. "The resulting decrease in HCW contact may lead to increased adverse events and a lower quality of patient care due to less consistent patient monitoring and poorer adherence to standard adverse event prevention methods (such...
Post a Comment
Read more

CareFusion Issues Update on Infant Breathing Product Recall

July 5, 2012 — Medical device maker CareFusion has issued an update reminding healthcare providers of its voluntary recall of its Air Life ™ Infant Breathing Circuit, initiated back in May. The US Food and Drug Administration (FDA) has classified this action as a class 1 recall, meaning there is a reasonable probability of serious adverse health consequences or death associated with use of the defective units. The update was posted July 2 on the FDA  Website. On May 29, 2012, CareFusion sent an  Urgent Recall Notice  to customers and distributors stating that the company had identified potential risks associated with the Air Life  Infant Breathing Circuit. The action was initiated after the company received complaints of the Y adapter within the breathing circuit developing cracks during patient use. "If a crack develops in the Y adapter, this could potentially result in a leak in the closed ventilation system, leading to a loss in the intended tidal volum...
Post a Comment
Read more

FDA Approvals: Pazopanib for Advanced Soft Tissue Sarcoma

CLINICAL CONTEXT Pazopanib was first approved by the US Food and Drug Administration (FDA) in 2009 when it became the sixth drug approved to treat advanced renal cell carcinoma. It is a small molecule with a mechanism of action as a tyrosine kinase inhibitor, specifically targeting receptors involved in angiogenesis and tumor cell proliferation. These include vascular endothelial growth-factor receptors 1, 2, and 3; platelet-derived growth-factor receptors α and β; fibroblast growth-factor receptors 1 and 3; stem cell factor receptors; interleukin-2-inducible T-cell kinase; leukocyte-specific protein tyrosine kinase; and transmembrane glycoprotein-receptor tyrosine kinase. STUDY SYNOPSIS AND PERSPECTIVE The FDA has approved pazopanib ( Votrient ) for the treatment of advanced soft tissue sarcoma in patients who have received previous chemotherapy. Pazopanib is already marketed for the treatment of advanced renal cell carcinoma; when it was approved in 2009, it became the six...
Post a Comment
Read more