Are Generic Prescription Drugs Safe?

Do you know why you should use extreme caution with generic prescriptions?
Because they are less expensive than branded medicines, the use of generic drugs in this country is growing.  In fact, roughly 75 percent of medications prescribed to American adults are purchased in generic form. 

Generic drugs are basically reproductions of brand name drugs with expired patents.  They can be up to 95 percent less expensive than branded versions because manufacturers don’t incur any advertising or development costs. While the price might sound appealing, due to certain safety issues, people should use extreme caution with generic prescriptions.

To obtain approval for public use, branded medicines are thoroughly tested for safety and effectiveness.  However, generic medications are not.  The only prerequisite for release of these medicines is a test for bioequivalence conducted on a small group of people by the manufacturer.  All this test needs to show is that the generic product delivers roughly the same amount of medicine to the bloodstream as the name brand product, at about the same rate. 

Essentially, according to the FDA, generic medications need to supply 80 percent to 125 percent of the medicine as compared to the brand name drug. Therefore, generic drugs may provide significantly less or a whole lot more of the medicine than is actually needed. 

Also, the bioequivalence test is only conducted on normal volunteers who have no other illnesses and are taking no other medications.  This makes the assumption that the generic medicine will have the same effect on people who have additional illnesses treated by additional drugs, and this may not be the case.  More detailed bioequivalence testing is needed over a wide range of populations in order to confirm safety and effectiveness of generic medications.

The switch from a brand name medication to a generic can be very dangerous for individuals with specific diseases and disorders due to possible drug failure.  For instance, a person with epilepsy cannot afford the risks of trying a generic medication if he or she has been free of seizures with a brand name medication. 

Dr. Michael Privitera, M. D., the Epilepsy Center Director at the UC Neuroscience Institute, has warned, "People need to be careful, and they need to talk with their doctor if a pharmacist suggests that they try a generic drug."  In terms of switching to generic he adds,  “It's an option if you have a medical disorder where the clinician and patient are able to monitor and detect a small change in drug response, but not an all-or-none problem such as epilepsy, heart arrhythmia or many other conditions."

Here are some added concerns when it comes to considering generic medications:
  • While generic drugs are required to contain the same active ingredient as a branded drug, they may contain different inactive ingredients.  While this doesn’t influence how a drug works, it can be harmful for individuals with certain sensitivities or allergies.  For instance, lactose and gluten may be used in generic medications as fillers or binders.  Ask your pharmacist to verify ingredients in the product before you purchase it.
  • Make sure to learn the generic and brand names of your prescription to avoid taking more than one version of the same medicine.
  • Lastly, always check with your doctor before considering a generic version of your medication.


Sources:
http://healthnews.uc.edu/publications/findings/?/8772/8776/
http://www.consumerreports.org/cro/2012/08/are-generic-drugs-safe/index.htm

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