CardioExchange Archive

November 15th, 2010

Let’s Bring CLOSURE to This Debate About PFO Treatment

Richard A. Lange, MD, MBA

In this blog, Rick Lange tells us how he would answer FAQs about PFO closure to prevent stroke. The controversy: Based on retrospective and nonrandomized studies, many physicians are convinced that percutaneous patent foramen ovale closure can reduce rates of cryptogenic stroke and transient ischemic attack. Although PFO closure devices are approved for stroke prevention in Europe […]

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October 19th, 2010

FDA Advisors Recommend No Changes for Aranesp

Larry Husten, PHD

The FDA Cardiovascular and Renal Advisory Committee has endorsed the status quo for Aranesp (darbepoetin alfa). The committee met on Monday to discuss the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) and voted 15-1-1 against withdrawal of the indication for chronic kidney disease (CKD) patients not on dialysis. The committee also voted against adoption […]

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October 8th, 2010

Abbott Withdraws Sibutramine from U.S. Market

Larry Husten, PHD

Abbott has pulled its weight-loss drug sibutramine (Meridia) from the U.S. market. A safety communication from the FDA said the “drug may pose unnecessary cardiovascular risks to patients.” Earlier this year the drug was withdrawn in Europe. Sibutramine was approved by the FDA in 1997. The FDA recommendation is based upon a recent analysis of data […]

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September 26th, 2010

Avandia: Lessons Learned and Unanswered Questions

Harlan M. Krumholz, MD, SM

The following is republished from Pharmalot, a widely read site that provides commentary on the pharmaceutical industry and related litigation. What should we make of the decisions on Avandia yesterday? There remains some controversy about the risk, but the concerns were sufficient, given the therapeutic alternatives, to bring about action. The Europeans decided to suspend sales […]

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September 23rd, 2010

FDA and EMA Split on Fate of Avandia

Larry Husten, PHD

The FDA and the European Medicines Agency announced separate and divergent decisions on the fate of rosiglitazone (Avandia) today. On the one hand, the FDA announced that it would allow rosiglitazone to remain on the market, though only with severe restrictions on its use. Additionally, the FDA said it would require the drug’s manufacturer “to convene […]

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September 20th, 2010

FDA Panel Unanimously Recommends Approval for Dabigatran

Larry Husten, PHD

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approval of  dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The panel was split on whether both dosages (150 mg bid and 110 mg bid) used in the RE-LY trial should gain approval, although in an informal straw […]

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September 17th, 2010

FDA Announces Safety Review of Pioglitazone

Larry Husten, PHD

The FDA announced today that it was undertaking a safety review of pioglitazone (Actos). The review was initiated after the FDA received data from Takeda, the drug’s manufacturer, suggesting a possible increase in bladder cancer in patients taking the drug for more than 2 years. The data are taken from a planned 5-year analysis of […]

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September 17th, 2010

FDA Grants Expanded Indication to CRT-D Devices

Larry Husten, PHD

The FDA has expanded the indication for CRT-D devices made by Boston Scientific. Previously, the devices had been approved only in NYHA Class III and IV patients. The expanded indication now includes Class I and II patients who have left bundle branch block. The expanded indication is based on data from the MADIT-CRT trial. “This approval […]

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September 16th, 2010

FDA: Dabigatran Gains, Lorcaserin Loses

Larry Husten, PHD

An alternative to warfarin is one step closer to reality. On Thursday, The FDA released briefing documents for next Monday’s meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the new drug application for dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The FDA reviewers agreed that dabigatran was at […]

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September 15th, 2010

FDA: Ticagrelor Deadline Extended; No Clear Signal on Sibutramine

Larry Husten, PHD

FDA watchers require patience. AstraZeneca announced that the FDA had extended its review of ticagrelor (Brilinta) until December 16. The previous deadline had been September 16. In July, the FDA Cardiovascular and Renal Advisory Committee voted 7-1 in favor of approving ticagrelor for the indication of STEMI and NSTEMI patients, but the committee and the FDA […]

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