Fda plavix warning - wsj.com
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The Food and Drug Administration said Tuesday doctors should avoid using popular heartburn drugs such asPrilosec in combination with the anticlotting medicine Plavix, after studies showed the combination may bluntthe effect of Plavix and increase patients' risk of heart attacks.
The makers of Plavix, Bristol-Myers Squibb Co. and Sanofi-Aventis SA, updated Plavix's label to warn againstthe combination use.
Plavix, which has annual world-wide sales of more than $8 billion, is commonly used to prevent clots in patientswith artery-opening stents or those who have had a heart attack or stroke.
About half of patients taking Plavix also take Nexium, Prilosec or a similar medicine to prevent stomachbleeding and ulcers, frequent side effects of Plavix. Nexium is made by AstraZeneca PLC, while Procter &Gamble Co. sells an over-the-counter version of Prilosec called Prilosec OTC.
A spokesman for AstraZeneca said the company is examining the FDA warning and "believes that researchneeds to continue into the concomitant use of these types of medicines."
A Procter & Gamble spokeswoman said the company is evaluating whether a label change on Prilosec OTC isnecessary. Sanofi said it updated its label after conducting two studies with Bristol-Myers that underscored thepotential interactions among the drugs.
The FDA's Mary Ross Southworth said the data submitted by Sanofi at the FDA's request show drugs likePrilosec inhibit a specific enzyme that activates Plavix. The FDA said it doesn't appear to help patients to takethe drugs 12 hours apart.
The Plavix label lists a total of 11 drugs that can inhibit the enzyme, including the heartburn drug Tagamet andthe antidepressant Prozac.
The FDA said there is no evidence that certain other heartburn drugs such as Zantac and Pepcid, which workdifferently from Nexium, interfere with Plavix.
The FDA and Sanofi said both Prilosec and Plavix can provide significant benefits to patients, and advisedpeople taking the drugs to consult their doctor.
The official warning follows a similar action in May by a cardiology group, the Society for CardiovascularAngiography and Interventions. The society acted in response to a study by the pharmacy-benefits companyMedco Health Solutions Inc. showing four common heartburn drugs boosted the risk of heart attack and strokeby 50% in cardiac patients taking Plavix.
Elliott Antman, professor at Harvard Medical School, co-authored a study published in the Lancet in Septemberthat didn't find increased risk from the drug combination. He said the FDA has "taken a very conservativeposition in issuing this alert, and that may be appropriate."
The American Heart Association was set to announce new recommendations on the use of certain heartburndrugs Wednesday.
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