Efficacy of Budeprion XL vs. Wellbutrin XL in Depression

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February 17, 2008

Mike Leavitt, Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201


Dear Secretary Leavitt,


We, the undersigned, request that the efficacy of the generic form of Wellbutrin XL (bupropion), known as Budeprion XL, be investigated. Many patients have become depressed after switching from the brand name version of bupropion to the generic form. In general, unless a doctor specifically requests a brand name only, pharmacies will automatically fill prescriptions with generic drugs. Additionally, insurance companies will often only pay for brand name medications when a generic is not available. Utilizing a potentially ineffective generic medication for the treatment of depression puts patients' health and safety at risk. Patients and physicians must be warned of the possibility of a worsening of symptoms while taking Budeprion XL. We urge you to consider the consequences of poorly controlled depression, and ask that you mandate independent testing of Budeprion XL to accurately determine its efficacy in depression.


The following links suggest the nature and extent of the problem:

NPR Recording
http://www.npr.org/templates/story/story.php?storyId=15218354

The People's Pharmacy Reports of Generic Drug Problems
http://www.peoplespharmacy.com/archives/generic_drug_problems/report_generic_drug_problem.php

Results of Consumer Lab Study Comparing Wellbutrin XL and Budeprion XL
http://www.consumerlab.com/results/wellbutrin-bupropion.asp

MSNBC Health Article
http://www.nbc6.net/msnbchealth/14327700/detail.html

Interview with CNN's Dr. Sanjay Gupta
http://transcripts.cnn.com/TRANSCRIPTS/0710/19/ltm.01.html


The following link discusses the maker of brand name Wellbutrin XL's attempts to prevent sales of the generic drug by starting a petition "intended to protect the public against the potentially harmful effects of generic versions of Wellbutrin XL that may not be a bioequivalent to Biovail's branded product, or may be misleadingly labeled."

http://www.law.com/jsp/article.jsp?id=1183626388782


The following FDA site can be used to report adverse reactions to the generic form of Wellbutrin XL:

https://www.accessdata.fda.gov/scripts/medwatch/


ACTIONS REQUESTED

Conduct independent studies on the efficacy of Budeprion XL for depressive symptoms.

Require warning labels on dispensed prescriptions of Budeprion XL to indicate that Budeprion XL may not work as well for depression as the brand name Wellbutrin XL, and warn patients and physicians to monitor for a worsening of condition while on Budeprion XL.

173 Signatures

  • Lisa Sievers
  • Aaron Jason Eisenberg
    • Comments
    • Look at http://www.consumerlab.com/news/news_101107_Wellbutrin-Bupropion.asp
  • Dawn Turek
    • Comments
    • Generic drugs, in general, should be held to the same standards as brand name drugs. I find it deeply disconcerting and troublesome that people who are taking this specific generic drug, as many do with generic drugs--in an attempt to save money or as advised by their doctor, are finding it ineffective or worse, experiencing detrimental effects as a result of the medication.
  • Rachel M. Israel Wise
  • Eric S. Shoup
  • Yoko Kusunose
  • Jeanne Chang
  • Amy McKibben R.N.
  • Brad Wilson
    • Address
    • Somerset, KY
  • Karen Weihs
  • jon gantert
  • Julie Litzke
    • Phone Number
    • 610-873-9255
  • Dianne Fudala
  • Kristen Kite
    • Comments
    • I tried the generic on two seperate occassions for 2 months, i really wanted it to work b/c it was cheaper. i found my depression worsening and physical symptoms of pain in my stomach. Once I switched back to the generic I felt better w/in a few days. Something is seriously wrong the generic version - please do something about it. This is wrong and in the end I had higher health care costs b/c of the gastrointestinal issues which garnered another rx and other wrong diagnoses. Please pull the generic from the market.
    • Address
    • 1557 Tonopah Drive, Cincinnati, OH 45255
    • Phone Number
    • 513-474-0828
  • JILL CABANISS
  • Jacqueline Banks
  • Lynette Carter
    • Comments
    • I was switched to Budeprion when it became available, and I have had to have my dosage adjusted to make the generic more effective (but still not as effective as Wellbutrin). Because of the way my insurance company charges for name brand drugs when a generic is available, I am forced to stay with budeprion.
  • Mallory
    • Comments
    • Please look into it! They are NOT the same.
  • cynthia grimes
  • Danielle Galvin
  • Leanne Fisk
  • Diane Drott
    • Comments
    • I suffer from depression and have had 7 years of success using Wellbutrin 300XL since 09/30/2000. Insurance switched me to generic budeprion XL beginning 05/16/2007. By06/03/2007, I started having hallucinations of blacking out (or actual blacking out) for short periods of time. Dizziness, extreme anxiety, fatigue, and depression followed. While driving, I jumped the curb of a very familar turn in my neighborhood and blew out my car's tire. On 07/02/2007 Dr. J decided to put me back on Wellbutrin 300 XL. Within days, I returned to normal. A recent article in Newsweek (Oct 13, 2008) by Mary Carmichael about generics mentioned that the FDA is investigating the generic Wellbutrin and prompted me to add my name to the petition.
    • Address
    • Brookhaven, PA
  • Erika Harrison
    • Comments
    • I'm being forced to take a generic that doesn't work as well as the Brand name because of insurance issues. I should be able to choose, since the two are clearly different.
  • Maria Antonietta Gutierrez
    • Comments
    • Have personal experience with this effect.
  • joni johnson
  • Erin S. Field
  • Wendy Sparks
  • Kamilah Offutt
    • Comments
    • Symptoms grew worse (scary) when my pharmacy/Insurance switched to the generic (Teva). Improvements shown only after returning to Wellbutrin XL.
    • Address
    • Albuquerque, NM
  • Angela Skogen
  • Abigail Diaz
  • Maria Miner
  • Brandy Freund
    • Comments
    • I have personally experienced increased side effects and a worsening of condition (chronic recurring major depression disorder) after switching from Wellbutrin XL (300 mg) to Budeprion XL (300 mg). My insurance company does not take into consideration a doctor's requirement for namebrand medication when determining copayable limits. The plan my company has contracted through UHC charges the difference between full price and the highest tier copay for my prescription plan ($134) plus the copay itself ($50). I request that the FDA further evaluate the efficacy of Budeprion XL vs. Wellbuthrin XL. If the FDA then considers the difference in the release rate between the two drugs to be within tolerable limits, even though a lesser efficacy has been documented for the generic, then insurance companies should be directed to recognize the doctor's requirement for namebrand medication when determining the copay.
    • Address
    • 860 Lenmore Court Orlando, FL 32812
  • Chris Talmage
  • Joyce Zach
  • Marilyn Bialek
    • Address
    • 9403 Bristol Lane
    • Phone Number
    • 2245692846
  • David Queen
  • GJ Schoonbrood
    • Comments
    • Adverse reactions to Budeprion XL 150 mg. I have stopped as of this day due to severe anxiety symptoms and painful headaches. The brand Wellbutrin XL 150 mg was the answer for me after many years trying medications. I have no answers for the future, but it cannot include this TEVA abomination.
  • Sandy Miller
    • Comments
    • bad reaction to generic very angry and nervous
  • Sandra Edwards
    • Comments
    • I had what I call "break through depression" which means that it was under control until my Rx was changed to budeprion XL. I asked my PA about the difference and of course she told me there was no difference. But there is!!!
  • Stacy Thomas
    • Address
    • Dallas, TX 75218
  • Dmitri Podolsky
  • Monica Berninghaus
    • Comments
    • The generic is not working for me at all
  • Kerry Adams
    • Comments
    • My pharmacy switched me to budeprion without my knowledge and within 2 weeks I was not feeling well. I had trouble sleeping, headaches, anxiety, depression, very tired. I just didn't feel like myself. I was having trouble thinking and speaking. Tomorrow I am back on wellbutrin XL. I have taken this drug for about 8 years and I love it...
  • Teresa Worley
    • Comments
    • horrible drug, very depressed again
    • Phone Number
    • 703-615-3415
  • Holly Smith
    • Comments
    • I am outraged that this has not been studied further yet.
  • Len Weller
    • Comments
    • AETNA insurance will only cover generic even with the Doctor demands for the original
  • Kerry Kravitz
    • Comments
    • My clinical experience indicates that efficacy of Budeprion is inferior to Wellbutrin
    • Address
    • 4370 Alpine Road, #210, Portola Valley, CA 94028
  • Michael Connery
    • Comments
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    • Address
    • В
    • Phone Number
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  • Mary Beth Carlson
    • Comments
    • I had been doing well on Wellbutrin XL when my pharmacist filled my prescription with Budeprion XL. As a registered nurse for 15 years, there were only a few instances that I was aware of where the efficacy of generics were substandard to that of the name brand drug. My depression had worsened and I was about to be prescribed a second antidepressant and an antipsychotic by a psychiatrist I had only spoken to for literally five minutes. A huge red flag went off in my mind as I was about to be taken down a pharmacological slippery slope of being overmedicated. Thank God I didn't start taking the other drugs. It's been over a year that I have been having difficulty concentrating, cannot finish tasks, wake several times during the night, take little pleasure in anything and have difficulty formulating sentences when speaking. I was conviced I was taking a placebo. This must be investigated. Do not let pharmaceutical and insurance companies dictate the health of Americans based on corporate greed.
  • Lisa Hazen