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FDA Policy on Plavix and Stents: Catch-22 FDA expected to advise extended use of antiplatelet meds for stent patients, but few realize this is an “off-label” use of the drugs |
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December 4, 2006 -- Many drug-eluting stent patients and their physicians, increasingly worried about reports of rare but potentially fatal blood clots, are eagerly anticipating the FDA's public meeting on stent safety this week. The FDA has announced that a key focus of the panel will be on "appropriate duration of clopidogrel use in patients who receive DES." Clopidogrel, brand name Plavix, is the antiplatelet medication cardiologists rely on (coupled with aspirin) to prevent blood clots (stent thrombosis) a known risk of stenting. In fact, drug-eluting stents and clopidogrel are a package deal for patients: it would be irresponsible to implant a stent without also prescribing antiplatelet drugs. But there's a catch. In a recent written statement to patient advocacy website Angioplasty.Org, the FDA wrote:
Off-label use of clopidogrel means that the companies making and selling this drug have not conducted studies to demonstrate the safety and efficacy of the drug after stenting in patients who have not had heart attacks or other emergencies classified as Acute Coronary Syndrome (the vast majority of stent recipients do not have ACS). It also means that they are not legally permitted to communicate with these patients about proper clopidogrel use, because according to the FDA: The only requirement for the stent manufacturers is that they must include a line in their package insert, stating the recommended duration of antiplatelet therapy (3 months for the Cypher stent and 6 months for the Taxus). "Every study has shown that when stent thrombosis occurs, it is often the result of patients discontinuing Plavix too soon. I believe the FDA's handing of this issue has been a contributing factor," says Angioplasty.Org editor Burt Cohen. "As an off-label use, no one really looked at the implications for patients of having to commit to an expensive, serious and long-term medication when they opted for stenting. No one looked into how to ensure compliance. It’s fallen completely on the cardiologist," says Cohen. Dr. John Spertus of the Mid-America Heart Institute of Kansas City, Missouri, who has done research on drug compliance among heart patients, reports: Cohen adds, "We have been reporting to the industry and the FDA for over a year that Angioplasty.Org, which receives almost 90,000 visits monthly, hears from hundreds of stent patients who've had problems staying on Plavix; others have been incorrectly advised by non-cardiac physicians to discontinue Plavix. Our concerns about compliance have fallen on deaf ears. "We’ve tried to obtain funding from drug and device companies for patient and professional education to improve Plavix compliance among stent patients, but the FDA's stance has made it very difficult. The drug companies make billions of dollars on Plavix, but tell us they can't legally support public education. The device companies, not surprisingly, have been reticent to draw attention to the expensive drug regimens their devices require." The FDA has finally publicly acknowledged what leading cardiologists already know: their recent statement on DES asserts that the duration of clopidogrel therapy and patient compliance are factors in DES thrombosis, and that more clinical data are needed to determine “the optimal antiplatelet therapy regimen for DES patients." Physicians are already prescribing Plavix much longer (12 months, sometimes life) than the current 3-6 months that the FDA has endorsed. But whatever "optimal regimen" is decided upon, compliance will remain a problem. Cohen observes: "Compliance isn't automatic. If you expect patients to take medications, they need to understand why and participate in the decision to get these devices. You can't rely on package inserts and 5 minutes of in-office instructions. People write Angioplasty.Org every day with confusion about drugs they are prescribed and questions about the devices in their hearts." A heart patient, who recently sent Angioplasty.Org a donation, wrote: "Your (site) is comforting and rights towards balance the ongoing DES controversy.... I am abreast of the discussion and less than panicked...thank you and continue to be the voice of reason on this issue." Editor Cohen concludes, "If government and industry are really interested in safety, they will start listening to the public, and utilize existing resources like Angioplasty.Org to properly inform, learn from and respond to the patient community." For more information, see: “The Catch-22 of Plavix and the FDA: Not My Job” Angioplasty.Org, founded in 1997, is an award-winning, highly regarded independent health website used by both health care professionals and patients. The site has been recommended by the Department of Health and Human Services and over 800 other referrers, receives 90,000 monthly visits and has reached 5 million people. |
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