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      National Mental Health Awareness Month, 2016   05/01/2016

      Proclamation 9433 of April 28, 2016 National Mental Health Awareness Month, 2016 A Proclamation Nearly 44 million American adults, and millions of children, experience mental health conditions each year, including depression, anxiety, bipolar disorder, schizophrenia, and post-traumatic stress. Although we have made progress expanding mental health coverage and elevating the conversation about mental health, too many people still do not get the help they need. Our Nation is founded on the belief that we must look out for one another—and whether it affects our family members, friends, co-workers, or those unknown to us—we do a service for each other when we reach out and help those struggling with mental health issues. This month, we renew our commitment to ridding our society of the stigma associated with mental illness, encourage those living with mental health conditions to get the help they need, and reaffirm our pledge to ensure those who need help have access to the support, acceptance, and resources they deserve. In the last 7 years, our country has made extraordinary progress in expanding mental health coverage for more people across America. The Affordable Care Act prohibits insurance companies from discriminating against people based on pre-existing conditions, requires coverage of mental health and substance use disorder services in individual and small group markets, and expands mental health and substance use disorder parity policies, which are estimated to help more than 60 million Americans. Nearly 15 million more Americans have gained Medicaid coverage since October 2013, significantly improving access to mental health care. And because of more than $100 million in funding from the Affordable Care Act, community health centers have expanded behavioral health services for nearly 900,000 people nationwide over the past 2 years. Still, far too few Americans experiencing mental illnesses do not receive the care and treatment they need. That is why my most recent Budget proposal includes a new half-billion dollar investment to improve access to mental health care, engage individuals with serious mental illness in care, and help ensure behavioral health care systems work for everyone. Our Nation has made strong advances in improving prevention, increasing early intervention, and expanding treatment of mental illnesses. Earlier this year, I established a Mental Health and Substance Use Disorder Parity Task Force, which aims to ensure that coverage for mental health benefits is comparable to coverage for medical and surgical care, improve understanding of the requirements of the law, and expand compliance with it. Mental health should be treated as part of a person's overall health, and we must ensure individuals living with mental health conditions can get the treatment they need. My Administration also continues to invest in science and research through the BRAIN initiative to enhance our understanding of the complexities of the human brain and to make it easier to diagnose and treat mental health disorders early. One of our most profound obligations as a Nation is to support the men and women in uniform who return home and continue fighting battles against mental illness. Last year, I signed the Clay Hunt SAV Act, which fills critical gaps in serving veterans with post-traumatic stress and other illnesses, increases peer support and outreach, and recruits more talented individuals to work on mental health issues at the Department of Veterans Affairs. This law will make it easier for veterans to get the care they need when they need it. All Americans, including service members, can get immediate assistance by calling the National Suicide Prevention Lifeline at 1-800-273-TALK or by calling 1-800-662-HELP. During National Mental Health Awareness Month, we recognize those Americans who live with mental illness and substance use disorders, and we pledge solidarity with their families who need our support as well. Let us strive to ensure people living with mental health conditions know that they are not alone, that hope exists, and that the possibility of healing and thriving is real. Together, we can help everyone get the support they need to recover as they continue along the journey to get well. NOW, THEREFORE, I, BARACK OBAMA, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim May 2016 as National Mental Health Awareness Month. I call upon citizens, government agencies, organizations, health care providers, and research institutions to raise mental health awareness and continue helping Americans live longer, healthier lives. IN WITNESS WHEREOF, I have hereunto set my hand this twenty-eighth day of April, in the year of our Lord two thousand sixteen, and of the Independence of the United States of America the two hundred and fortieth.  
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maintainin

Generic Wellbutrin Doesnt Work As Well As Name Brand

12 posts in this topic

Posted

This article seems to validate what folks taking generic wellbutrin have been saying for awhile. From MSNBC:

Report questions generic antidepressant

By Jacqueline Stenson

Contributing editor

MSNBC

For seven years Linda Douglas has been treating her depression with the antidepressant Wellbutrin, first with a twice-a-day version and then later with a more convenient once-a-day pill called Wellbutrin XL. The drug, she says, "renewed my joy for living."

All that changed earlier this year when she switched to a generic version of Wellbutrin XL 300 milligrams to save money. Instead of paying $250 for a three-month supply of the brand drug, she was paying just $53. The cost savings were welcome, but Douglas, 48, a telecommunications project manager in Columbia, Md., says the depression returned during the six months she took the generic antidepressant.

"I was questioning, did I take my medication today? Something's not right," she remembers. Occasionally she'd experience symptoms of a panic attack, or worse. "The suicidal thoughts came back," she says. At that point, Douglas started to suspect there was something wrong with her medication, and in August asked her doctor to switch her back to the brand-name version. She says she felt better within days.

New test findings by ConsumerLab.com that were released to MSNBC.com showed that one of a few generic versions of Wellbutrin XL 300 mg, sold as Budeprion XL 300 mg, didn't perform the same as the brand-name pill in the lab. The results offer a possible explanation for the experience of Douglas and reportedly hundreds of other people who wrote to a syndicated newspaper column called The People's Pharmacy with related complaints, says Dr. Tod Cooperman, president of ConsumerLab.com, a Westchester, N.Y.-based provider of independent evaluations of health and nutrition products.

Though experts agree the majority of generic drugs perform the same as their pricier brands, some say the results raise questions about whether that is always the case.

"When we saw the results we were shocked," says Cooperman.

Marc Goshko, executive director of legal affairs at Teva Pharmaceutical Industries, which sells Budeprion XL 300 mg, says the drug met all requirements of the Food and Drug Administration, including showing that the drug performed similarly to the brand in the lab and also was released into the bloodstream of healthy volunteers at the same rate. He did not cite specifics of that research.

In an e-mail response, FDA spokesperson Sandy Walsh said, "We are investigating the complaints regarding generic Wellbutrin, but cannot offer specifics at this time."

The FDA does not require generic drugmakers seeking approval to do clinical trials of their drugs on hundreds or thousands of people as is required for brand drugs. Instead, the agency requires lab data and "bioequivalence" testing in about 24 to 36 healthy volunteers showing that the drug appears in the bloodstream in a similar manner to the brand, says Walsh.

Dr. Sidney Weissman, a member of the board of trustees of the American Psychiatric Association and a professor of psychiatry at Northwestern University in Chicago, says that while he hasn't heard complaints about generic Wellbutrin XL himself, the findings are cause for additional investigation. "Is the FDA method for approving these different methodologies adequate?" he says.

"I, for one, am concerned," Weissman adds. "This raises questions for me on the reliability of FDA testing for these types of drugs."

Consumer complaints

ConsumerLab.com began investigating after Joe and Terry Graedon, authors of The People's Pharmacy column, approached them with the consumer complaints. "In almost all cases people were saying their depression returned," says Joe Graedon, a pharmacologist. While the Graedons had received complaints from readers about generic drugs before, "we had never received this volume of response," he says.

For the testing, ConsumerLab.com purchased both the original Wellbutrin XL 300 mg sold by GlaxoSmithKline and the generic version sold by Teva, the same one that Douglas took and that many other readers complained about, and had six samples of each drug analyzed. While both drugs contained the stated amount of the active ingredient, bupropion, "dissolution testing" showed that the generic drug, which has a different time-release mechanism, released the active ingredient into a solution at a quicker rate.

"The Teva product released nearly half of its ingredients in the first four hours," says Cooperman. "The original Wellbutrin released 25 percent."

Within the first two hours, 8 percent of the original Wellbutrin had dissolved, compared with 34 percent of the Teva product, according to Cooperman. By 16 hours, both drugs had released all the medicine.

If the active ingredient is released more quickly into a patient's bloodstream, that could mean there is less medication available to the patient later, which may explain why people like Douglas experienced a return of their depression, Cooperman says. It also may explain why some readers who wrote in complained of more side effects, such as headache, irritability and nausea, given they may have received a higher dosage of the medicine upfront, he says. "Too much Wellbutrin can cause side effects, even the potential for seizure," he says.

Andrea Hofelich, a spokesperson for the Generic Pharmaceutical Association in Arlington, Va., called into question the validity of the ConsumerLab.com findings, saying the company's testing was "inadequate" compared to what the FDA requires for a generic drug to hit the market.

"The FDA is the world's gold standard for reviewing brand and generic medicines," she says.

Teva's Goshko also took issue with ConsumerLab.com's conclusions: "How the product dissolves in you is really the correct question here, not how it dissolves in a test tube."

But Mark Boesen, a pharmacist in Phoenix and a spokesperson for the American Pharmacists Association, says the findings offer "a reason for pause." Since the research was only done in the lab, not in real patients, the findings aren't conclusive, he says. Still, "the combination of anecdotal evidence and the conclusions of the in vitro study would lead one to believe that patients might receive a different therapeutic outcome from the two medications."

ConsumerLab.com also tested two generic versions of a twice-a-day Wellbutrin SR and found that variations were within FDA limits of acceptability.

Cooperman says he could not determine what the FDA variation limits are for the once-a-day extended release products. "We haven't seen anything published stating what's acceptable," he says. The FDA declined to comment specifically on the ConsumerLab.com report.

But given that the generic drug was approved by the FDA, "it appears that they are giving a lot of leeway in how the drugs are released," Cooperman says. "It would seem very difficult to imagine that the results we saw would be acceptable results."

The FDA's Walsh says the agency "cannot offer any examples where generics have been shown to not perform as expected" and that "health professionals and consumers can be assured that FDA-approved generic drugs have met the same rigid standards as the pioneer (brand name) drug."

Call for monitoring

But as the FDA plans to speed up approval of generic drugs, Cooperman and Graedon say they're concerned about safety. Graedon says the FDA should do more monitoring of generic drugs once they hit the market and are taken by thousands of people.

Other experts interviewed for this story say that in the majority of cases, switching from a brand drug to a generic poses no problem and offers an important cost savings. But some have concerns about certain medications, especially those used to treat heart conditions and epilepsy, where being properly medicated is critical.

While generics are required to have the same active ingredients as the brand drugs, the FDA allows for some variability in the amount of the active drug. Usually that variability is no big deal, says Boesen. However, "there is a small number of medications that we do worry about switching back and forth," he says.

Doctors and pharmacists refer to these drugs as having a "narrow therapeutic index." Translation: "If you get too much you can get sick. If you get too little you don't get any benefit," says Boesen.

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Posted

Thanks a lot for the info!!

I take Buproprion (generic Wellb) I have no problem with it. Did they mean what they typed Budiprion or was that a misspell?

Gentle Sun

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Posted

Budiprion is Teva's brand name for their generic wellbutrin. If that makes sense. Why they cant call it bupropion, which is wellbutrins ACTUAL generic name is beyond me. I'm sure alot of folks dont have problems, BUT alot of folks DO It needs to be changed. A 25% difference in release rate seems huge to me and if this still falls within FDA limits then I would be shocked. Well........actually I wouldnt. As more time goes on, the more faith I lose in the FDA. I wonder sometimes wether the publics health and welfare is really their top priority. Bottom line is people are different and as we all know different AD's affect people differently. Why wouldnt release rates? Teva needs to fix it.

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Posted (edited)

Just to clarify. the article isnt talking about all generic wellbutrin. There are few different companies out there making generic wellbutrin. The problem seems to be coming from the one made by Teva. If your bottle just says "bupropion" its probably not made by Teva. They are calling it Budiprion. If you go to MSNBC and read the article they do have a picture of the wellbutrin made my Teva. Of course I cant link it, but the pill does have "682" stamped into one side of it.

Edited by maintainin

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Posted (edited)

I take Teva's version of bupropion that they confusingly call Budeprion. I take 300 mg/day of the XL version. This article is interesting to me and confirms my experience when I switched from name brand to generic. I noticed more of a "kick", within just an hour, and I thought "this version must be releasing faster". I was a bit cranked up, like an amphetamine feeling. The next day, the energy spike was more mild, and the next day, milder, and so on. Within a week, I had adjusted and didn't feel any difference throughout the day. At this point, I've been on Budeprion 300 XL for several months, and I can hardly tell I'm on it, it's that smooth. The antidepressant effects are still going strong.

I guess I'm one of the lucky ones who can adjust to and tolerate a faster release version of bupropion. I can understand how people who are more sensitive to medication would get more side effects because of the faster release, and then come down and possibly crash later in the day, as the release tapers off. Maybe this has to do with liver metabolism. Maybe I have a slower liver, so the bupropion breaks down at a more consistent rate throughout the day. Maybe the ones who suffer from the faster release have faster livers. Or maybe I'm just a junkie. In any case, if you react badly to a switch to generic bupropion and don't adjust within a reasonable amount of time, your doctor can tell your insurance company that the name brand is "medically necessary" for you. This should lessen your copayment.

Edited by suburgatory

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Posted

Since I do so much research on these things, I came across the articles about generic WBXL and decided I was only going to take WB brand. Luckily I'm still on the WB150XL which has no generic yet and my doc has authorized me to take 2 pills if/when I increase to 300XL. If I stay with 300XL then I'll have to have my doc put "Name Brand required" in order to get my mail in pharmacy to provide it. I am pretty adamant about taking name brands in general. Usually my doc gives me samples of name brand meds and I'm NOT going to switch to something else once I start the name brand. It's likely all in my head that the name brands are better, but Hey, this is all about what's in our heads, isn't it? :hearts:

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Posted

Interesting article, thanks for posting it Brian. I have never taken the name brand, so I have nothing to compare to. I actually just switched from 150mg SR to 200 mg SR today. When I was on 75mg and then 150mg SR both were manufactured by TEVA; however, the 200mg SR I picked up today is manufactured by "Global". I haven't seen any info about them on here anywhere. I'm hoping that is good news?!

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Posted

Fellow Wellbutrinians,

I

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Posted

yeah my doc said brand name is better

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Posted

"Better" is a subjective term and can only be determined by your own body. I must say I was nervous about switching to generic, but my psychopharmacologist told me she only had one patient who had a negative reaction to generic, and that helped to ease my concern. When I actually gave generic a try, I liked it better than the name brand! It gave me more of a lift, which I really needed. And after about a week, it smoothed out to the point where I couldn't even tell I was on it anymore. Some people require a longer adjustment. Give generic a reasonable chance before you reject it. Just because some people had a bad reaction and put their story in the paper, that doesn't make them the experts.

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Posted

My boyfriend just pointed me to this article last week. My depression seems to come and go and had really been in full force that week. He was kind enough to help me recognize where my depression level was (I don't always recognize that I'm getting depressed). He mentioned that maybe my med wasn't working as well as I thought it was. It was then I started doing more research and that's why I'm here. I have a call into my therapist to talk to her about switching back to the name brand (if possible) to see if that will make a difference.

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Posted

AHH HA... ME AND BURGY WERE RIGHT.... THE DRUG DOES RELEASE FASTER IN YOUR SYSTEM! How funny that if you scroll down to the other Generic -verses- Brand posts that are pages long... you will find out that we performed this experiment for ourselves and on myself. (Me specifically for 3 months) and came to the same conclusion that the MSNBC article stated.

Fortunately, having the medicatioin release in my system faster does not affect its effectiveness. And the longer you are on the medication, you will reach what is called a "Steady State" and it wont matter much if you skip a day or take it at a different time in the day every now and then since the medication stays in your system for a while with a slow half life from what I understand.

ALTHOUGH, and as I stated before..... if after a month or 2 and you are still having problems with the generic, then it's probably worth it to go back to the brand or change medications. I believe our mental health is much more important than trying to save money. For some of us, continued depression/anxiety can cost us our jobs and then we'd have no money to buy any medication.

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