CardioExchange Archive

July 4th, 2013

FDA: Olmesartan Can Cause Sprue-Like Enteropathy

Larry Husten, PHD

The FDA is warning that the angiotensin II receptor blocker olmesartan (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) may cause severe diarrhea. According to an FDA safety announcement, olmesartan “can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss.” The warning is being added […]

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June 28th, 2013

FDA Turns Back New Indication for Rivaroxaban to Prevent Stent Thrombosis in ACS Patients

Larry Husten, PHD

Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the  general use of […]

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June 27th, 2013

Novel Heart Failure Drug from Novartis Gains ‘Breakthrough Therapy’ Designation from FDA

Larry Husten, PHD

Serelaxin, the novel therapy under development for the treatment of acute heart failure, has received a “breakthrough therapy” designation from the FDA, according to Novartis, the company developing the drug. The designation, the FDA explains, “is intended to expedite the development and review of drugs for serious or life-threatening conditions” and requires “preliminary clinical evidence that demonstrates the […]

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June 24th, 2013

Roller Coaster Path to Approval for Eliquis Uncovered by FDA Documents

Larry Husten, PHD

After the presentation and publication of the pivotal ARISTOTLE trial,  the novel anticoagulant apixaban (Eliquis, Pfizer and Bristol-Myers Squibb) was widely expected to be  a blockbuster. But then it got bogged down at the FDA where initial hopes for a speedy approval were dashed after highly critical reviews. Approval of the drug was delayed for 9 months […]

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June 7th, 2013

FDA Advisory Panel Backs Looser Restrictions on Avandia

Larry Husten, PHD

After two days of deliberation an FDA advisory panel has recommended that the severe restrictions (REMS) placed on rosiglitazone (Avandia, GlaxoSmithKline [GSK]) be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker after many years of controversy and bad news. Only 5 panel members voted to continue the current severe restrictions. […]

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June 4th, 2013

With One Big Exception FDA Reviewers Back More Benign View of Avandia Trial

Larry Husten, PHD

The FDA has released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed by […]

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May 31st, 2013

Two FDA Officials Quarrel Over Safety of Angiotensin-Receptor Blockers

Larry Husten, PHD

Two FDA officials are quarreling in public about their different views about the safety of angiotensin-receptor blockers (ARBs), according to a story by Thomas Burton in Friday’s Wall Street Journal. One official, Thomas Marciniak, contends that ARBs may increase the risk for cancer. Marciniak has been a vocal critic of FDA’s efforts to assess drug  safety. In the […]

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May 29th, 2013

Report on the RECORD Trial Released

Larry Husten, PHD

An independent re-adjudication of the RECORD trial has confirmed the trial’s original finding that rosiglitazone does not increase cardiovascular risk. But critics of the trial and the drug are unlikely to be appeased by the new result. The re-adjudication of RECORD will be the subject of an extraordinary 2-day FDA advisory committee meeting next week on […]

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May 24th, 2013

Spinning RECORD: Battle Over Rosiglitazone Heats up Two Weeks Before Crucial FDA Meeting

Larry Husten, PHD

Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline [GSK]). This will be the second time an FDA panel has wrestled with the fate of the drug and expectations have been that the discussion will once again be heated. But at […]

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May 21st, 2013

European Medicines Agency Starts Review of Combined Use of Drugs that Block the Renin-Angiotensin System

Larry Husten, PHD

The European Medicines Agency (EMA) said last week that it was initiating a review of the combined use of agents that block the renin-angiotensin system (RAS). The three classes of RAS-blocking drugs (ACE inhibitors, ARBs, and direct renin inhibitors) are used to treat hypertension and congestive heart failure. The EMA said that the review was being performed to […]

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