What ABOUT Generics???
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What ABOUT Generics???
| Mon, 04-26-2004 - 6:44pm |
So what are your opinions of generics? I know OTC recently came out with a generic, and so did Cyclessa (I am on that right now, a triphasic pill).
So here's the thing - the pharmacists said that it contains the same amount of active ingredients... I always heard that generics had to have at least 80% of the active ingred. I would hope it would be 100% for the active ingredients, but when my friend went on OTC's generic she totally broke out and had weird side effects she never had before.
Anyone else experienced different symptoms switching to generic? It's super cheap, but I just started the pill a little under 2 months ago and want to let my body get used to it.
Thoughts ladies?
Are generics as effective too? I have heard conflicting arguments on this one...

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More specifically (quoted from the article):
"FDA Requirements for Generics
Following the patent expiration of a branded product, generic manufacturers may submit an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA). The requirements for approval of an ANDA are less stringent than those mandated for an innovator drug. The generic manufacturer need only demonstrate that the product is therapeutically equivalent to the brand-name drug, which requires evidence that the two drugs are pharmaceutically equivalent and bioequivalent. Two products are considered pharmaceutically equivalent if they contain the same active ingredient(s) and are identical in strength, dosage form, and route of administration. Bioequivalence is achieved if the generic product demonstrates no substantial difference in rate or extent of absorption when compared to the reference drug.3
The FDA does not specify a minimum number of participants for studies demonstrating bioequivalence. According to the agency, "The total number of subjects in the study should provide adequate power for BE demonstration, but it is not expected that there will be sufficient power to draw conclusions for each subgroup."4 Consequently, bioequivalence testing for generic drugs typically involves a small cross-over study of 20 to 30 individuals.3
Bioequivalence studies compare the rate and extent of absorption of the active ingredient(s) following administration of the generic and brand-name product in the same individuals under similar conditions. Outcome measures evaluated include the area under the drug concentration time curve (AUC), which indicates the extent of absorption, and the maximum concentration (Cmax) and the time of maximum concentration (Tmax), which indicate the absorption rate.5
The FDA definition of therapeutic equivalence allows differences in bioequivalence parameters between products. The AUC values for the generic and reference drug may differ by as much as 20% to 25% and still fall within the acceptable range for bioequivalence. Typically, the FDA considers two drugs to be bioequivalent if the 90% confidence interval limits for the mean AUC of the generic drug fall within the range of 80% to 125% of the value for the reference product (Figure 1).4 In general, these results must be demonstrated for at least 75% of the individuals studied.6 A less-stringent standard is applied to differences in Cmax and Tmax values, which are considered less crucial for demonstrating therapeutic equivalence than AUC. The minimum circulating levels at the end of the dosing period are not specified.
Specific Concerns with OCs
Some have questioned whether the FDA standards for bioequivalence are stringent enough for certain classes of drugs, including oral contraceptives.3,6-9 If the FDA guidelines are applied to an OC formulation containing 20 µg EE, the hormone dose in a therapeutically equivalent generic product could be as low as 16 µg EE (80% of 20 µg) (Figure 2). According to some analyses, the difference may even be greater: Given the acceptable potency variation of ±10% between lots of a reference product, the difference in AUC between a generic and a brand-name product could theoretically be as much as 28% (80% of 90%), potentially resulting in a dose of 14.4 µg EE.3 Progestin doses could be similarly affected.
"Today's oral contraceptives have extremely small amounts of active ingredients," says Rudi Ansbacher, MD, Professor in the Division of Reproductive Endocrinology at the University of Michigan. "The potential problem is that when you use these small microgram doses and you're allowed to have just 72% of what's in the brand-name pill, you actually may be giving only about 14.4 µg of ethinyl estradiol." "
The issue that some people may have is with the possible difference in bioequivalence--yes, they contain the same active ingredients, but how available the ingredients are to the body doesn't have to be identical between the two formulations.
The pills are formulated with a "buffer", in a sense, as each women has a different requirement for how much progestin it will take to stop ovulation and how much of each hormone she needs to control bleeding, and this varies from day to day and definitely from woman to woman. The pills are effective for the majority of women regardless, because there is a higher dose than what is actually needed for most women. The differences are most likely to be seen in the side effects, not the effectiveness. When I took a generic, I definitely had more nuisance side effects than with the name brand, which was and is my preference.
The author of the article is not in favor of generic oral contraceptives considering the FDA's current definition of bioequivalence (due to the very small doses) and the size of the study group (20-30 women) used to prove it. If you (anybody) are concerned about whether generic is right for you, talk about it with your doctor, talk about it with your pharmacist, and if you're not comfortable with it, you can take the name brand. Yes it costs more, but what's your peace of mind and quality of life worth to you?
Judie
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