Generic Brands: Are they really Equivalent?

When we are prescribed steroids, we sometimes choose to use the generic brand because it is cheaper. Why spend tons of money on the brand name if you can get the same cream for a lower price?

Well, we may need to rethink our bargain.

A study done in 1991 showed that not all off-brand topical steroid products hold up to their supposed counterpart.

From the abstract: “Six generic formulations of 5 topical steroids were compared for bioequivalence with their trade name counterparts using an in vivo vasoconstriction assay. Two of the six generic forms were found to show significantly less vasoconstriction then the respective trade-name topical steroids.”

Without even meaning to, you could be using a topical steroid that is less potent than the prescribed objective. I have not been able to find evidence that this has been rectified since the 1990’s. This is extremely troubling, something that needs attention if it is still an ongoing occurrence.

What is more discouraging is the fact that this relates to ALL generic drugs, not just to topical steroids.

In 2011, a Supreme court decision was made: If there is a side effect seen in a brand name drug, the company must place it on the label. However, the generic company is not under such law and does not have to share those findings on the label.

As explained by Dr. Roger Steinert in his article, Generic vs Brand-Name Drugs: An Ongoing Debate, he describes the fatal flaw of how generic drugs work. The FDA says that the generic brand must 1) use the same concentration of active ingredient as the brand name and 2) same route of administration as the brand name. However, they are not reviewed and are not as monitored as their brand name “counterpart”. This leaves an immense room for error.

So, next time you pick up that generic brand, remember what you are paying for. What a backwards world we live in…

 

Study From: A Double-Blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay. Arch Dermatol. 1991;127(2):197-201. Olsen EA.

Not Just A Dermatology Subject

Dermatologists are not the only ones allowed to prescribe topical steroids. Other persons whom prescribe these drugs are general practitioners, our family doctor. However, they are not specialized in this area. We already know some dermatologists push past the guidelines, but GPs are even less educated on steroids and all of their adverse effects if overprescribed or prescribed incorrectly.

In the FDA Evaluation and Research paper, they point out how our GPs can be truly hurting us. “… family physicians frequently prescribed betamethasone dipropionate and clotrimazole to children younger than 5 years of age and for use on genital skin disorders.”

Not only should this super potent steroid be prescribed with utmost caution to adults, but then add an anti-fungal (clotrimazole) into the mix, and you’ve got mega trouble. NEVER mix antifungals with topical steroids, and never use a steroid on a fungal infection. It is also stated in topical steroid inserts to never use these topical steroids on the genitals since it is extremely sensitive and most likely under occlusion (diaper).

This paper also talks heavily about research they constructed from 202 cases. The median age was 7 years old, a mix of both genders, and drum roll…. A median of topical steroid use for 169.3 days. That comes out to a little over 5.5 months of consecutive use. The shortest time was 1 day, and the longest was 7 years. This is why people have steroid phobia from this type of disregard for topical steroid guidelines.

If doctors wish to have the trust of their patient, then patients need to see that doctors can be trusted. We are the ones who have to endure the consequences. We are the ones who will have to suffer. There has to be open and honest communication on a level playing field. So many lives can be saved from needless pain if topical steroids were not only used strictly by a guideline (NOT by someone’s discretion), but also to know that the guideline set is correct and appropriate.