Are generic medications as safe and effective as brand name medications?
The term generic, when applied to foods or household products, is used to describe a less expensive, sometimes less effective or lower quality copycat version of a brand name product. However, most generic drugs, although usually less expensive, are generally as effective and of the same quality as the brand-name drug.
According to the FDA, all drugs, including brand name drugs and generic drugs, must work well and be safe. The FDA applies the same standards for all drug manufacturing facilities, and many companies manufacture both brand-name and generic drugs.
In fact, the FDA estimates that 50% of generic drug production is by brand-name companies. They may make copies of their own medications or another other company’s brand name drugs and then sell them without the brand name.
Despite the fact that the active ingredient in a generic medication is the same as in the brand name counterpart, small differences could effect how the generic medication works in your body. For some people, these slight differences may cause the drug to be less effective or lead to side effects.
Several health-related organizations, including the Epilepsy Foundation of America and the American Thyroid Association, have raised concerns about the mandatory use of generic medications proposed by some states or required by health plans to save money. An example of the controversy about generic versus brand name medication is the drug levothyroxine, used to treat people with hypothyroidism. Since many people with low thyroid are sensitive to very small changes in the dose of their medication, switching between brand name and generic versions of levothyroxine can cause symptoms of too little thyroid medication or side effects from too much medication.
If brand-name drugs and generic drugs are equivalent, why do they act and look different?
Although FDA requires that generic drugs have the same risks and benefits as their brand-name counterparts, the fact is many types of blood pressure medications, heart medications, hormones, antiepileptic drugs, antidepressants, many liquid form medications and some antibiotics are just not as effective as the brand.
The following differences explain why the generics may cause some different effects:
1. Bioavailability
Bioavailability is the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action. Bioequivalence is a comparison of products with respect to their bioavailability. Bioequivalency means that the same amount of active ingredient is delivered to the body by the generic medication as by the brand-name drug.
The FDA requires that the generic medicine have a comparable bioavailability to that of the brand-name drug, but NOT the exact bioavailability. Legally, bioequivalence of different versions of a drug can vary by up to 20%, because for most drugs, such variation does not noticeably alter effectiveness or safety. This means that one generic may have achieved values that lie between 80% and 100% and another values that lie between 100% and 125%.
Although generic drug approval requires demonstration of chemical equivalence and bioequivalence, these equivalencies do not guarantee therapeutic equivalence (the same clinical effect and the same safety profile). And actually several generic psychoactive medications are less effective than their brand-name counterparts. For drugs where there is a very narrow therapeutic band, for example, where a patient gets antiseizure medication, plus-or-minus twenty percent may not be appropriate.
Remember, there are “parameters” for bioavailability that must be met, not an exact number.
2. Inactive ingredients
Other common problem is that the inactive ingredients are different. Inactive ingredients such as binders, fillers, coloring and flavoring, are allowed to differ but must occur in a ratio to the active compound similar to that of the reference drug. It is assumed that these inactive ingredients will not alter the performance of the product. However, since these ingredients may contain lactose or gluten products, they could change gut motility and drug absorption in sensitive patients.
3. Manufacturing processes, Technology
Wellbutrin XL is a well-documented case where many people react to the generic differently. This is not because the drug itself is less effective, but because XL is the Extended Release version, and the generics use a slightly different release technology.
Does every brand name drug have a generic drug?
Not all off-patent drugs have generic versions. Sometimes a drug is too hard to duplicate, or adequate tests are not available to prove that the generic drug acts the same as the brand name drug. Sometimes the market for the drug is too small that producing another version does not make business sense.
The term generic, when applied to foods or household products, is used to describe a less expensive, sometimes less effective or lower quality copycat version of a brand name product. However, most generic drugs, although usually less expensive, are generally as effective and of the same quality as the brand-name drug.
According to the FDA, all drugs, including brand name drugs and generic drugs, must work well and be safe. The FDA applies the same standards for all drug manufacturing facilities, and many companies manufacture both brand-name and generic drugs.
In fact, the FDA estimates that 50% of generic drug production is by brand-name companies. They may make copies of their own medications or another other company’s brand name drugs and then sell them without the brand name.
Despite the fact that the active ingredient in a generic medication is the same as in the brand name counterpart, small differences could effect how the generic medication works in your body. For some people, these slight differences may cause the drug to be less effective or lead to side effects.
Several health-related organizations, including the Epilepsy Foundation of America and the American Thyroid Association, have raised concerns about the mandatory use of generic medications proposed by some states or required by health plans to save money. An example of the controversy about generic versus brand name medication is the drug levothyroxine, used to treat people with hypothyroidism. Since many people with low thyroid are sensitive to very small changes in the dose of their medication, switching between brand name and generic versions of levothyroxine can cause symptoms of too little thyroid medication or side effects from too much medication.
If brand-name drugs and generic drugs are equivalent, why do they act and look different?
Although FDA requires that generic drugs have the same risks and benefits as their brand-name counterparts, the fact is many types of blood pressure medications, heart medications, hormones, antiepileptic drugs, antidepressants, many liquid form medications and some antibiotics are just not as effective as the brand.
The following differences explain why the generics may cause some different effects:
1. Bioavailability
Bioavailability is the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action. Bioequivalence is a comparison of products with respect to their bioavailability. Bioequivalency means that the same amount of active ingredient is delivered to the body by the generic medication as by the brand-name drug.
The FDA requires that the generic medicine have a comparable bioavailability to that of the brand-name drug, but NOT the exact bioavailability. Legally, bioequivalence of different versions of a drug can vary by up to 20%, because for most drugs, such variation does not noticeably alter effectiveness or safety. This means that one generic may have achieved values that lie between 80% and 100% and another values that lie between 100% and 125%.
Although generic drug approval requires demonstration of chemical equivalence and bioequivalence, these equivalencies do not guarantee therapeutic equivalence (the same clinical effect and the same safety profile). And actually several generic psychoactive medications are less effective than their brand-name counterparts. For drugs where there is a very narrow therapeutic band, for example, where a patient gets antiseizure medication, plus-or-minus twenty percent may not be appropriate.
Remember, there are “parameters” for bioavailability that must be met, not an exact number.
2. Inactive ingredients
Other common problem is that the inactive ingredients are different. Inactive ingredients such as binders, fillers, coloring and flavoring, are allowed to differ but must occur in a ratio to the active compound similar to that of the reference drug. It is assumed that these inactive ingredients will not alter the performance of the product. However, since these ingredients may contain lactose or gluten products, they could change gut motility and drug absorption in sensitive patients.
3. Manufacturing processes, Technology
Wellbutrin XL is a well-documented case where many people react to the generic differently. This is not because the drug itself is less effective, but because XL is the Extended Release version, and the generics use a slightly different release technology.
Does every brand name drug have a generic drug?
Not all off-patent drugs have generic versions. Sometimes a drug is too hard to duplicate, or adequate tests are not available to prove that the generic drug acts the same as the brand name drug. Sometimes the market for the drug is too small that producing another version does not make business sense.
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