PHARMACY

Sutent studies show connection with heart failure

BY Diana Alickaj

WASHINGTON Pfizer’s Sutent (sunitinib), which is indicated for advanced Kidney cancer and a rare form of gastrointestinal cancer, is being further studied for possible connections to causing heart failure in patients.

According to published reports, the study assessed 48 patients who lived in a “real world” setting and consumed the drug for either advanced kidney cancer, or gastrointestinal Stromal Tumor and study its affects on the heart. The study was funded by Pfizer, and found that 15 percent of the patients—almost double the increase that was seen in clinical trials—had experienced worsened heart conditions. According to published reports, some that were noted were symptomatic left ventricular dysfunction or heart failure, which began between a reported 22 days and 435 days after the patients started on the drug.

Another two studies, one posted in the New England Journal of Medicine and the other done by The Lancet, noted that using Sutent also increased blood pressure in patients, which added to the risk of heart failure. Pfizer responded with a statement that the drugs did pose health risks bur that they were “medically manageable in most patients and underscore the importance of having a collaborative team of health-care professionals working together to appropriately manage patients who have limited available options” in treating their cancer.

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Cornelius elected to chairman of Bristol-Myers Squibb board

BY Adam Kraemer

NEW YORK Bristol-Myers Squibb Wednesday announced that the company’s board of directors has elected chief executive officer James Cornelius as chairman of the board. He will continue serving in his previous role as well.

The board also named Textron’s chairman, president and chief executive officer Lewis Campbell, chairman, president as lead independent director. James Robinson III, co-founder and general partner of RRE Ventures, resigned as non- executive chairman of the Board, a position he has held since June 2005. He will remain a director of the company until May 6, 2008, the date of the company’s annual meeting of stockholders, when he will retire pursuant to the Board’s mandatory age retirement policy.

Cornelius was named chief executive officer of Bristol-Myers Squibb on April 30, 2007, after serving as interim chief executive officer since September 12, 2006. He joined the Board in January 2005. “I am excited by this tremendous opportunity to serve as chairman of the Board of this great company,” he stated. “Over the past 18 months as chief executive officer, I have been deeply impressed by the commitment and dedication of our employees to our mission and goals, and the strong belief they share with me in the promise of Bristol-Myers Squibb as a BioPharma leader for the future.”

Cornelius was previously a member of the board of directors of Eli Lilly, a member of its executive committee and chief financial officer from 1983 to 1995.

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Duragesic pain patches getting recall

BY Adam Kraemer

WASHINGTON Ortho-McNeil-Janssen, a unit of drug and consumer giant Johnson & Johnson on Tuesday said it was recalling certain strengths of its Duragesic pain patches, which have the potential to expose patients to a dangerous gel inside.

All lots of Ortho-McNeil’s 25 microgram-per-hour strength patch of Duragesic are being recalled, in coordination with the Food and Drug Administration.

The recalled patches may have an opening which could result in release of the gel—made of the drug fentanyl—inside, Reuters reported. Exposure to fentanyl directly can cause serious harm, including breathing problems and overdose, which can be fatal, the company said.

All the recalled patches have an expiration date on or before December 2009.

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