 charting the potential negative effect of the results of the ENHANCE trial on physician prescribing habits of Vytorin. Although many physicians haven't decided to drop the cholesterol-lowering drug altogether as a treatment option, some prescribers are being cautious in prescribing Vytorin for first- and second-line use.

ENHANCE pitted Vytorin—which combines the statin simvastatin (the active ingredient of Zocor) with Zetia (ezetimibe), a drug that blocks absorption of cholesterol in the gut—against a statin alone. In the study, Vytorin performed no better than a statin alone at reducing arterial plaque in a group of patients with severe congenital hypercholesteremia.

Of the 150 internists, general practitioners, and cardiologists interviewed, general practitioners said that they were less likely to prescribe Vytorin as a first-line drug, with a net change of -20 percent of patients. Use of Vytorin as a second-line medication is expected to drop across all specialties by 8 to 14 percent of patients. In third-line treatment, however, Vytorin prescriptions received a boost from 20 to 30 percent.

"The report shows that while patients are asking about the drugs, the physicians are not indicating that they are likely to quickly switch their patients off the drug, but they are indicating that they will switch how they prescribe the drug," said Anna Marie Napolitano, GfK vice president and category business leader, cardiovascular.

Some of the doctors told GfK that they might consider switching their first-line prescriptions to a generic or to Crestor. Since there is no indication of a safety issue, many are choosing to wait for more information to be released.

"It doesn't seem like there is going to be long-term pain for this brand," Napolitano told 

 on Friday. "I think [prescribers] are just going to ride it out and see what happens in the future. In the near term, it looks like doctors will back off on first-line prescribing and switch [back to Vytorin] down the line."

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News Analysis

A new study shows that while doctors aren't in a rush to stop prescribing Vytorin, they are considering it less often as a first-line treatment option.

Possible Prescription-Tier Drop for Vytorin

Baxter Healthcare has temporarily suspended manufacture of multidose vials of the anticoagulant Heparin, after reports of severe allergic reactions and hypotension—including four deaths—after administration of large doses of the drug.

According to FDA, the number of adverse events involving the drug spiked from 100 in 2007 to nearly 350 since the beginning of 2008. Approximately 40 percent of the incidents are listed as serious.

Nine lots of the drug were voluntarily recalled in January; however, FDA has since tracked adverse reactions well beyond the recalled lots.

Side effects from the drug have ranged from difficulty breathing, nausea, vomiting, and excessive sweating to rapidly falling blood pressure.

FDA stated that the drug is often administered prior to coronary artery bypass graft surgery, and to kidney patients before they undergo dialysis. In some situations, Heparin treatment is initiated using a high-bolus dose intravenously over a short period of time, usually less than one hour. The reported adverse events occurred in patients who were given Heparin via this method.

"FDA concurs with Baxter's decision to halt manufacture of heparin sodium in multiple-dose vials," said Janet Woodcock, FDA deputy commissioner for scientific and medical programs. "FDA is vigorously investigating to determine the root cause of these serious reactions associated with the use of heparin made by Baxter. In the meantime, patients and healthcare professionals who cannot obtain alternative sources of heparin should use caution in administering any Baxter multiple-dose vials that remain."

 on Thursday reported that a Chinese plant that supplies Baxter with the active ingredient for the drug is under investigation. By Monday, Bloomberg was reporting that the failure to inspect was 

Baxter controls about 50 percent of the US heparin market, for about $30 million in revenue. Its principal competitor in the heparin business is APP Pharmaceuticals of Schaumburg, IL, which announced yesterday that it was working closely with FDA to 

 of its heparin product to help stave off a shortage.

Baxter blood thinner has been put on ice while the Feds examine the huge increase in adverse reactions.

Pharmaceutical Executive-02-20-2008

Possible Prescription-Tier Drop for Vytorin

Baxter Suspends Heparin Production