PHARMACY

Study on mice suggests Avandia may lead to bone loss

BY Adam Kraemer

LA JOLLA, Calif. In addition to the recently added black box warning regarding heart problems, Avandia may have another warning to add, as a study raises questions about the drug’s contribution to bone loss, according to published reports.

Based on a study conducted on mice, researchers are concerned that over the long term, Avandia (rosiglitazone) may speed osteoporosis, the thinning of the bones that can lead to dangerous and even fatal fractures. The findings appear in the Dec. 2 online issue of Nature Medicine.

“Our study suggests that long-term rosiglitazone usage in the treatment of type II diabetes may cause osteoporosis due to both increased bone resorption and decreased bone formation,” said study senior author Ron Evans, a professor at the Salk Institute for Biological Studies in La Jolla, Calif. “Because Avandia is effective in controlling glucose and restoring the body’s sensitivity to insulin, we do not recommend that people stop their treatment. You must balance the benefits against the complications.”

An estimated 3.5 million or more patients in the U.S. take Avandia. The drug affects a key cellular protein called the peroxisome proliferator-activated receptor. In their study, the California team discovered that, in mice, activating this receptor also stimulates the production of osteoclasts, cells whose key function is to degrade bone.

“Anyone who is already at risk for osteoporotic fractures should consider an alternative anti-diabetic drug,” added Paul Brandt, an associate professor of neuroscience and experimental therapeutics at Texas A&M Health Science Center College of Medicine. “There are many alternatives, “ he said, adding that “It may be possible to blunt some of Avandia’s effects with anti-osteoporosis drugs such as bisphosphonates, raloxifene, vitamin D and calcium.”

Avandia is produced by GlaxoSmithKine. Sales of the drug have fallen drastically since May, when the Food and Drug Administration issued a safety alert regarding the potential cardiovascular issues.

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Mylan’s nebivolol receives approvable letter from FDA, efficacy not at issue

BY Allison Cerra

NEW YORK Mylan’s new anti-hypertension drug has received a nearly green light from the Food and Drug Administration.

While an approvable letter from the FDA did not raise any questions related to safety or efficacy of nebivol, a novel beta blocker, Mylan and its licensing partner, Forest Laboratories, did report that final marketing approval would depend on the duo’s ability to resolve deficiencies in its manufacturing facility in Belgium, issues which the letter addressed.

At this time, the companies and the FDA have agreed upon product labeling text and the proposed brand name is currently Bystolic.

The companies anticipate an expeditious resolution to this issue, and Forest continues to plan for a Jan 2008 launch meeting for Bystolic.

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Caraco receives tentative FDA approval for generic Lexapro

BY Allison Cerra

WASHINGTON The FDA has granted tentative approval for Caraco’s abbreviated new drug application for escitalopram oxalate tablets (escitalopram), 5 mg, 10 mg and 20 mg.

Escitalopram is indicated for the treatment of major depressive disorder and is the generic bioequivalent of Forest Laboratories’ Lexapro.

Caraco and Forest Laboratories have been involved in a patent litigation over the generic Lexapro since July. Lexapro tablets had U.S. sales of approximately $2.5 billion for the 12-month period ending Sept. 30, Caraco said.

“We are extremely pleased to receive this tentative approval,” said Caraco’s chief executive officer, Daniel Movens. “The ANDA was filed with a Paragraph IV certification that we do not infringe Forest’s Lexapro patents or that they are invalid. As previously disclosed, we are currently involved in litigation with Forest Laboratories that will determine whether we may launch our generic product prior to the expiration of these patents. Though the outcome of this litigation is uncertain, we remain confident in our position and continue to expect a favorable conclusion.”

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