Generics less effective/safe than branded medications in treating LUTS

April 26, 2009

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."
-end-
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.

American Urological Association

Related Medication Articles from Brightsurf:

New medication may treat underlying causes of hypertrophic cardiomyopathy
Mavacamten, a new investigational cardiac medication, may improve heart function for people with thickened heart muscle leading to obstructed blood flow through the heart, a condition known as obstructive hypertrophic cardiomyopathy.

Therapy plus medication better than medication alone in bipolar disorder
A review of 39 randomized clinical trials by scientists from UCLA and their colleagues from other institutions has found that combining the use medication with psychoeducational therapy is more effective at preventing a recurrence of illness in people with bipolar disorder than medication alone.

Kids diagnosed with ADHD often don't take medication regularly
Children diagnosed with ADHD inconsistently take their prescribed medication, going without treatment 40 per cent of the time, a new study has found.

Long-term medication for schizophrenia is safe
Researchers at Karolinska Institutet in Sweden and their colleagues in Germany, the USA and Finland have studied the safety of very long-term antipsychotic therapy for schizophrenia.

Which is more effective for treating PTSD: Medication, or psychotherapy?
A systematic review and meta-analysis led by Jeffrey Sonis, MD, MPH, of the University of North Carolina School of Medicine, finds there is insufficient evidence at present to answer that question.

ADHD medication: How much is too much for a hyperactive child?
When children with ADHD don't respond well to Methylphenidate (MPH, also known as Ritalin) doctors often increase the dose.

Pain medication use by children after common surgeries
About 400 caregivers reported pain medication use by children after common surgeries such as hernia, elbow fracture, appendectomy or adenoid removal in this study.

Bringing cancer medication safely to its destination
Treating cancer more selectively and more effectively -- this could be achieved with an innovative technology developed by teams of researchers at the Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP) and the Ludwig-Maximilians-Universität München (LMU).

Bullying linked to student's pain medication use
In a school-based survey study of all students in grades 6, 8, and 10 in Iceland, the use of pain medications was significantly higher among bullied students even when controlling for the amount of pain they felt, as well as age, gender, and socioeconomic status.

New medication gives mice bigger muscles
Researchers from Aarhus University, Denmark, have studied a new group of medicinal products which increase the muscle- and bone mass of mice over a few weeks.

Read More: Medication News and Medication Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.