Generics less effective/safe than branded medications in treating LUTS

LINTHICUM, MD, April 26, 2009–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."

NOTE TO REPORTERS: Experts are available to discuss this study outside normal briefing times. To arrange an interview with an expert, please contact the AUA Communications Office at the number above or e-mail Lacey Dean at LDean@AUAnet.org.

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

About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 16,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs for members and their patients.