AUA Update - Generic Meds Not As Effective

[icnmgrjill]

I can intepret this study in two ways. #1.. that generics simply aren't as complete and effective as the original medication which the FDA says is impossible. Why? Because a generic is supposed to be identical in active ingredients than the original approved med. or #2.. are drug companies worried that they are losing marketshare... thus trying to discourage the use of generics?? Who knows. - Jill

GENERIC SUBSTITUTES LESS EFFECTIVE/SAFE THAN BRANDED MEDICATIONS IN TREATING LOWER URINARY TRACT SYMPTOMS

Men taking generic drugs may be more likely to have less effective results and more adverse events than if they were using branded medications, according to new data from researchers in New York. Researchers presented a study at the 104th Annual Scientific Meeting of the American Urological Association (AUA) showing that generic substitutes for alpha blockers and 5-alpha reductase inhibitors (5-ARIs), two classes of medications used to treat lower urinary tract symptoms (LUTS) in men, are less effective than their branded counterparts.

Over eight weeks, the study tested 212 men taking branded alpha blockers or 5ARIs with an average age of 64, who were switched to generic alternatives by their primary care physician or due to insurance coverage. The researchers measured the efficacy of the medications using several parameters, including the International Prostate Symptom Score (IPSS), peak flow rate (Qmax), post-void residual urine (PVR), voiding diary information, International Index of Erectile Function (IIEF), ejaculatory function and the prevalence of adverse events.

In the men who were switched to generic medications, the IPSS and PVR rates increased and Qmax decreased. In addition, the men experienced several new side effects, including dizziness (4.6 percent), nasal congestion (3.2 percent) and ejaculatory dysfunction (3.6 percent) for those switching alpha blockers, and ejaculatory dysfunction (4.7 percent) and erectile dysfunction (5.8 percent) for those switching to generic 5-ARIs.

“This preliminary study shows that some generics are not as effective as their branded counterparts and that men should consult a physician if a generic alternative is not providing results. Given that this is an early study, interpretation should be cautious as patients were not blinded as to which medication they were receiving and there may be a bias against generic medications on the part of patients,” said Kevin McVary, MD, an AUA spokesman. “Often, men switch because of cost or insurance company regulations; but, it is important to ensure efficacy and consider potential side effects prior to switching medications. A physician should be able to monitor the patient and may recommend switching back to the branded medication if efficacy decreases or side effects increase while taking a generic medication.”


Kaplan, S; Chung, D; Sandhu, J; Te, A. Generic substitutes are neither as safe nor effective as branded medications: experience in men treated for lower urinary tract symptoms (LUTS). J Urol, suppl. 2009: 181, 4, abstract 1799

[Sally939]

I had heard that generics have to have the same type of active ingredient but that the amount could vary. I could not remember the range so I looked it up and below is what I found. I think below is true but it will not stop me from taking/trying generics.

Bioequivalence

In bioequivalence studies, the goal of testing is to determine if the drugs are functionally equivalent. The FDA requires that any approved drug be effective within a 20% range of the original patented or brand name drug. This means that the effectiveness may be 20% greater or 20% less effective than the brand name so that two generic drugs could contain as much as a 40% difference from each other. Therefore, a drug may be legally chemically equivalent but not at the same time clinically equivalent.

[darlene]

This is very disturbing. Most insurance plans, mine included, really push the use of generics.

[Laura78]

Originally Posted by darlene

This is very disturbing. Most insurance plans, mine included, really push the use of generics.

I agree & my insurance co. is the same way. UHC - no real surprise there.

[Trishann]

So true Jill. Also blood pressure medicine should not be switch, but due to insurance coverage, you sometimes don't have a choice. Our medical health almost don't belong to the doctors, it belongs to the insurance. I do believe people's life is being played with by the insurance.

Doctors spend many years in school to learn but yet the insurance makes the decision in what you can or can not do. God help us!

Trish

[MommaWuzzi]

Believe it or not (I learned this when I worked at a biotech company), the order in which all the active ingredients are added to the mill (an overgrown mortar and pestle, basically) and combined, and the amount of time they spend there actually changes the activity and effectiveness. You could have an IDENTICAL generic that has a completely different effectiveness profile, just because the ingredients are combined in a different order. It is pretty much impossible to have a generic be perfectly equal to the name-brand, unless the generic is manufactured by the same company...

[MommaWuzzi]

The urologist I saw yesterday said that the generics for ditropan, etc., do not work, and will prescribe only name-brands of those drugs... wanted to share that.