Is generic Plavix as safe and as effective as the name brand?
On May 17, the US Food and Drug Administration (FDA) approved the blood thinner Plavix (clopidogrel bisulfate). The medication decreases the likelihood that platelets will clump and produce clots in the arteries; thus, risking a heart attack or stroke. It is FDA-approved to treat individuals who have suffered a recent heart attack or stroke or those that have partial or total blockage of an artery.
“For people who must manage chronic health conditions, having effective and affordable treatment options is important,” noted Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research. “The generic products approved today will expand those options for patients.”
Generic products become available when the patent of a medication expires. As Dr. Webber noted, the generic version is less expensive. As anyone who has recently filled a prescription and does not have a health insurance plan to cover all or a portion of the cost, filling a prescription can be a budget buster. In the past, many physicians were reluctant to prescribe a generic drug for fear that it might not be equivalent to the name brand. Even today, many physicians prefer not to prescribe generics. The reasoning is that the generic may vary in potency from a name brand. Every medication has a therapeutic range where it is effective. Below that range, it is less effective or non-effective. Above that range, untoward side-effects are more likely to occur. In the case of Plavix, internal bleeding can occur. The therapeutic range of pharmaceuticals varies between individuals. Weight, metabolism, and genetics influence the effectiveness. That is the reason that different dosages of medications are on the market.
In the past, some generic products were not equivalent to the name brand. For example a 500 mg generic might be comparable to a 400 mg or 600 mg name brand. Even today, some generics may not be equivalent. The good news, however, is that if a generic is FDA-approved it is equivalent to the name brand. The agency notes: “Generic drugs approved by FDA are of the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those for brand-name drugs.”
As noted above, Plavix has a boxed warning to alert healthcare professionals and patients that the drug may not be as effective for individuals with certain genetic factors that affect how the body metabolizes the drug. However, tests for these genetic factors are available to ensure that the medication is the right choice for them. In addition, certain medications, such as proton pump inhibitors (i.e., Prilosec (omeprazole) and Nexium (esomeprazole)), reduce the effect of Plavix, placing a person at greater risk for heart attack and stroke.
Plavix may cause bleeding, which can be serious and sometimes lead to death. While taking the drug, individuals may bruise and bleed more easily, experience nose bleeds, and it may take longer for all bleeding to stop. The drug is dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information.
Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals have gained FDA approval for 300 mg clopidogrel. Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals have received approval for 75 mg clopidogrel.