Generic Name: Plavix
What is Plavix?
The Cmax of the active metabolite is twice as high following a single 300 mg clopidogrel loading dose as it is after four days of 75 mg maintenance dose. In the 75 to 300 mg dose range, the pharmacokinetics of the active metabolite deviates from dose proportionality: increasing the dose by a factor of four results in 2.
After a single, oral dose of 75 mg, clopidogrel has a half-life of approximately 6 hours. The clinical evidence of the efficacy of Plavix is derived from three double-blind trials involving 77,599 patients. The CAPRIE study Clopidogrel vs. Aspirin in Patients at Risk of Ischemic Events was a comparison of Plavix to aspirin. The CURE study included 12,562 patients with ACS without ST-elevation UA or NSTEMI and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischemia.
Patients were required to have either ECG changes compatible with new ischemia without ST-elevation or elevated cardiac enzymes or troponin I or T to at least twice the upper limit of normal. Patients were randomized to receive Plavix 300-mg loading dose followed by 75 mg once daily or placebo, and were treated for up to one year. Patients also received aspirin 75-325 mg once daily and other standard therapies such as heparin. The number of patients experiencing the primary outcome CV death, MI, or stroke was 582 9.
Most of the benefit of Plavix occurred in the first two months, but the difference from placebo was maintained throughout the course of the trial up to 12 months see Figure 1.
In this case, Dr. Starfield's husband personally brought the findings of the autopsy to her doctor's attention, who subsequently submitted an adverse event report to the FDA, stating that she was receiving Plavix, which may have contributed to her cerebral hemorrhage and subsequent death. Starfield's points of contention with the current medical system was the lack of systematic recording and studying of adverse events, and her death highlights this situation, as it is quite possible that it was the Plavix-aspirin combination that killed her, yet if it hadn't been for an autopsy and her husband insisting on an adverse event report, no one would ever have been the wiser about such a connection.
Starfield herself pointed out that her statistics were likely far lower than the real count, as they only included people who died in the hospital. They did not include as there's no data people who suddenly die outside a hospital setting, due to a drug side effect. What if a sufficient number of adverse event reports had been filed prior to her taking a combination therapy of Plavix and aspirin - would her life have been spared. It's impossible to speculate of course, but what is clear is that someone's life would eventually be spared if adverse event reporting is taken seriously.
Starfield's there are out there, who suddenly collapse and die, and no one is ever made the wiser about their true cause of death. When a specific adverse event is expected eg, bleeding with clopidogreladverse event reporting to FDA should be mandatory, and the manufacturer should be obliged to conduct postmarket surveillance. When a harmful effect is confirmed, the FDA should issue a warning to physicians and require a warning in the package insert.
How should I take Plavix?
A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Get StartedMy MedicineSave your medicine, check interactions, sign up for FDA alerts, create family profiles and more. Get StartedDrug NewsMobile Drug Information AppDrug, supplement, and vitamin information on the go.
DownloadFeatured ContentImprove Your ConcentrationThese Foods and Drinks Can HelpAllergy AppFight allergies with daily forecasts, local alerts, and personalized tips. How to use PlavixRead the Medication Guide provided by your pharmacist before you start taking clopidogrel and each time you get a refill.
What conditions does Plavix treat.
What should I avoid while taking Plavix?
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Attorneys Nancy Hersh and Mark Burton are providing strategy for litigation involving thousands of injured victims with their work in the group that is handling litigations in both state and federal courts. Plavix is a drug that is supposed to help to avoid cardiac events, such as heart attack and stroke.
The Food and Drug Administration issued a boxed label warnings for patients who are what they deem "poor metabolizers" since for these patients the drug is not effective.
Plavix side effects
Is it safe to still breastfeed. I am also a pediatric nurse practitioner, this can be helpful information for my patients as well. Comment Post Cancel admin 8 03-20-2014, 10:40 AM Dear Hgrossklaus, Clopidogrel Plavix selectively inhibits platelet adenosine diphosphate-induced platelet aggregation,thus it reduces the initiating factor in clotting.
Hale thinks this is unlikely to happen, but we have no data on it yet. We are currently enrolling breastfeeding mums for a Plavix study, contact the InfantRisk Center at 806-352-2519, if you would like to participate. Aspirin on the other hand is certainly implicated in Reye syndrome, but most often in older children not infants who have a viral illness such as flu or chickenpox. Even when present at small plasma levels in these children, it was implicated in Reye syndrome.
However, the amount in breastmilk is incredibly low even following large therapeutic doses.
Common Plavix ide effects may include:
Clopidogrel is an anti-platelet medicine.
However, we do not yet know if it is useful or safe when given as a loading dose of 600 mg before cardiac catheterization for outpatients with stable symptoms and who are not thought to be in the midst of a heart attack.
For more specific information based on your specific condition and current medications, consult with your health care provider, particularly before taking any action.
You should not do both without talking to your doctor.
Where can I get more information?
Sermo Report Indicates that Ticagrelor is Likely to Affect the Standard of Care for ACS PatientsEx Bristol-Myers Exec Pleads Guilty in Plavix Case.
Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses of Plavix.