Dr. Oz featured an alarming post on his website this week. Apparently, generic drugs aren’t always as they seem. Dr. Tod Cooperman, President of ConsumerLab.com, claims that lax and loose FDA guidelines for drug content and quality control means you aren’t always getting what you expect. See what you think:
What You Need to Know About Generic Drugs
By Tod Cooperman, MD, President, ConsumerLab.com
ConsumerLab.com is offering a 24-hour free pass to Dr. Oz viewers. Visit ConsumerLab.com/DoctorOz now and get immediate access to ConsumerLab.com’s unbiased evaluations of certain generic drugs, multivitamins and more.
More than 80% of the drugs we take in the US are now generic versions of brand name medications. You may think that these drugs are equivalent to their branded counterparts, but that’s not always the case. Here are some important facts and tips to stay safe with generic drugs.
Fact: You may get more or less active drug from a generic.
The FDA only requires that you get 80% to 125% of the drug from a generic medication compared to the original drug. What’s even more concerning is that there are often many different generic versions of the same drug, and each of these may be different as well. Consider this: If you take a generic which only meets the minimum requirement and refill that prescription with one that’s at the maximum limit, you’ve just increased your effective dose by 45% percentage points – and you would have no way of knowing this from the labels, but it could certainly affect you. The opposite could also happen, and you would be getting a lot less drug than you were previously – which could also affect you.
This is particularly troubling for medications for which blood levels must be kept in a narrow range in order to be effective and/or to avoid toxicity. These can include:
- Thyroid medication
- Anti-seizure medication
- Blood thinners
- Asthma medications
Fact: Other than the active ingredient, a generic may contain very different other binders and fillers.
Most of the ingredients in a pill are not the active ingredient but other ingredients needed to hold the pill together, coat it, and control the way the pill delivers its drug in your body. These other ingredients can be different in a generic version of a drug. It is possible to have an allergic reaction or sensitivity to one of these ingredients. With some extended-release products, the brand name formula is still patented, so the generics may be completely different in their formulation. This can affect how fast or slow they release their drug and how this is affected by things like whether you take the pills with food or not.
Fact: Generics are not tested like brand name medication.
While brand name medication is tested for safety and efficacy before being approved, generics are not. The only human test in people that is required is a bioequivalence test, conducted by the manufacturer in a small number of healthy individuals. This test must show that the product delivers approximately the same amount of drug into your blood stream and approximately the same rate.
Fact: Labels on most generic drugs are incorrect.
The FDA requires that the package inserts for generic drugs show the data (the “pharmacokinetic” data) from the brand name medication as if it is were based on the performance of the generic drug. In actuality, the data for the generic is typically different, but the FDA does not release this information.
Interesting. The reader that forwarded me this link, Steve, is a fellow multiple myeloma (bone marrow cancer) survivor. We shared experiences of dealing with generic oxycodone from different manufacturers having different strenght and effectiveness. I knew immediately when things changed; thinner 5 mg pill didn’t seem to be doing the job. I asked my pharmacist about it and he told me CVS couldn’t get their preferred type and had to substitute that month. Steve had a similar experience. He even did some research and discovered the names of two different manufacturers of generic oxycodone. He now requests the one that works best for him.
So this story seems to have some credibility from personal experience.
Feel good and keep smiling! Pat