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Subscribe to RSSWASHINGTON — Teva Pharmaceuticals is pulling its generic version of a popular antidepressant off the market after a federal analysis showed the pill does not work properly.
The Food and Drug Administration called on Teva to withdraw Budeprion XL 300 after chemical testing showed the drug releases its key ingredient faster than the original drug Wellbutrin, made by GlaxoSmithKline.
The action contradicts the FDA's previous update on the issue in 2008, when regulators said the drugs are essentially the same. That review came after hundreds of patients complained that Teva's drug did not work or caused side effects like headaches, anxiety and insomnia.
The agency said it completed its own study of the two pills in August, which showed Budeprion does not release into the blood at the appropriate rate.
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I took generic Effexor XR for 2 months when it first came out... I know firsthand that generic SSRIs are NOT the same as their name brand counterparts! Yeesh!
I have been taking generic Effexor XR and Seroquel XR since Express Scripts sent them to me. My shrink said if I had any side effect, and he said any at all to let him know and he would fax a script to get me back on the name brand.
I am lucky because I have tolerated both very well and I tend to have problems with any new med.
It's true generics are not the same. It's how your body processes the medication. The active ingredient in the generic can vary by a certain percentage (and I forget what that is) from the name brand.
When you are switched to the generic you need to be aware of any changes and let your doctor know right away. This way your doctor can take care of any problems as soon as they show up.
A good doctor or pharmacist knows that generics are not created equal. They can vary as much as 20% from the active ingredient in the trade name medication and the different fillers can change the absorption rates and qualities. This is especially important with drugs that affect blood sugar and epileptic conditions.
Just as I have argued with Express Scripts mailorder drug plan GENERICS ARE NOT THE SAME. All the drug plans push you into taking the generic form of so many drugs because they say they help with whatever health issue you have and they are cheaper. Express Scripts sent me the generic of Seroquel even though I had ordered Seroquel because that month the generic form came available. They did not notify me before sending me the drug and when I called they insisted there was nothing I could do unless I got a new prescription from my doctor for the real drug. The bottom line is the drug companies want to spend less money regardless of the patients safety. The generic may have the important parts of the medicine and also have added other fillers that you have no idea of until you break out in a rash, or any of many allergic reactions, or could cause your depression to get worse.
Believe it or not it even happened to my little dog with flea medicine. I bought generic, had the main ingredients but must of had something else in as a filler that made my dog break out in such an allergic rash over his whole body I had to rush him to the vets.
So listen carefully, GENERICS ARE NOT THE SAME. Do not let your drug supplier push them on you until you have really checked them out. To the Drug Companies you will be hearing from not only me but from my lawyer for the drug you pushed on my husband that now has shown to cause additional problems that have gotten worse and I understand the government states that these problems could last even after stopping the medication.
The people need to speak up about these issues with the drug and health insurance companies pushing products and lesser procedures on us. It is those companies that should be held accountable for the health issues today not the doctors, hospitals or other health workers.
Yep, generics are not the same. When I got a the generic for Lexapro, my depression returned. Now that I am back on the name brand, the depression has lifted. I don't trust doctors or drug companies anymore.
Same thing with birth control. The name brand birth control was the best I took, I lost weight, had no side effects and periods were normal.
Insurance and doctors keep insisting I take generic, and guess what? I gained weight, have spotting between periods (despite taking at at the EXACT same time every day) and I have cramping with periods.
So all these internet experts cry about Obamacare making insurance companies give free birth control when they could cheap generics elsewhere. They do not understand that if a woman get sick on birth control because it's the wrong kind for their body. If the cheap or free pills is incompatible, they won't stay on it for long, and will go without instead.
Inadaze, Obamacare doesn't give people free birth control. it just makes insurance companies cover it.
Shouldn't that be tested BEFORE it is on the market?
The drug companies do the drug trials and publish the results. Talk about the fox guarding the hen house... Unless the drug trial kills or harms enough people to warrant them not releasing it for fear of lawsuits, they cherry pick the results to show it as being effective with little or no side effects. When side effects are reported later, the drug companies can then claim to be shocked since that never came out as a problem with those kind of results in the drug trials.
My late husband took generic Paxil CR for 28 days and then shot himself. I wrote the FDA and never heard nothing other than we got all your information. I supplied lot number, manufacturer, and all the data to trace it back because it literally killed my husband. He would have never have taken his own life if he had not started these drugs that are mind altering and make a person do things these would never do without being under the influence of these medications. Now children are growing up without a father and wonder why. The FDA is a joke said politely. Anti-depressants are poison and should not be given to anyone. People have to use talk therapy, exercise, and getting involved in anyway they can to make them feel better about their own life. I guarantee if you look at the soldiers that have committed suicide over the last several years, you would find that several were on anti-depressants. The drug companies pay out huge millions of dollars to support the Republican Party and the FDA is biased and does nothing. I only chose not to sue the drug companies and go to court for protection of my children's identity. Now however, I speak out whenever I can about these drugs when I read these type of stories. The FDA does not track suicides from people on anti-depressants. I wonder why?
I'm so sorry for the loss of your husband:(
Thank you.
Sounds like your husband died of a pre-existing condition. Blaming the condition on the med is crazy.
Very sorry about the loss of your husband. However, antidepressants saved my life over fifteen years ago. Everyone is different. I do agree that most generics that I've tried are not so good......but try to convince your insurance company of that!
JoAnn, I'm sorry for your loss. My brother took his life after he refused to take antidepressants. It's so hard ot understand why some people choose to take their own life. Please don't blame the drug. If he was on Paxil, then he had some type of problem. Talk therapy, exercise and getting involved don't always solve the problem. When a person gives up on life nothing will change their mind.
klondiko, only one question are you a doctor? My late husband complained of not feeling right after taking starting anti-depressants. The doctor then increased the dosage level and his personality was totally different from the norm throughout the day. The only way he seen out of his misery was his final answer which is the way he chose. I am just thankful that he only done this to himself and no one else like many other stories I read on a weekly basis in this country. The high school shooting in Colorado years ago was also connected to these anti-depressants. You can google it online. The FDA chooses to ignore the violence these drugs cause to individuals, families, and the community. Yes, people can have problems before they take these drugs, but these drugs chemically alter the way of thinking in the brain. For the people that try to stop taking them, the side effects are hell at best. You can find a lot of information on the internet about anti-depressant side effects. The bad outways the good anyday of the week. These are dangerous drugs not only to those taking them, but to anyone around them. Law enforcement even admits that the FDA does not track suicides from people on anti-depressants. With todays technology and math to calculate probability and statistics, I wonder why the FDA doesn't want or keep better records. There job is to protect the public from inferior harmful medications. In this type of prescription, they fail the test over and over again. Why do you think there is so many anti-depressants now on the market. The more different types, the harder it is to graph and track and linl the data when suicides happen. I am glad anti-depressants work for some people, but they are very dangerous to others. These are chemicals put into a pill that are produced in pill factories and packaged for public consumption. I for one will always advocate a non prescription for anti-depressants versus other help for patients. You do whatever it takes to help someone, but do not let them take anti-depressants. They are addicting and life altering for family members that survive a suicide in a family. It is just not the immediate family affected, but extended family and friends too.
Jo-Ann, I feel sorry for you and your children for your lose but I need to let you know that not all people who are on antidepressants turn suicidal, in fact I am an example of someone who if I didn't take antidepressants I probaly wouldn't be here today to write this. I was having major issues and nightmares for many years as a result of a bad childhood experience and not knowing what was the problem and yes I did have many suicidal thoughts just so I could stop the nightmares then I was diagnossed with panic attack/aniexty disorder and severe depression disorder. I am know on an anti-anxiety medicine and two anitdepressants and the nightmarres occur rarely now and I have not had a suicidal thought since I started the medicines. Some peoples depression just don't get better with the medicine but not all. I also know of someone who shot himself and left behind a wife and 3 wonderful children a couple of years ago and he had depression but was not taking anything for it because he was ashamed to admit he had a problem, I feel if he took care of his problem he would be alive today. Again I am sorry for your lose but please don't discourage others from seeking help through medicine and therapy because I am a living example they do work.
JoAnn I am so so sorry that this happened. It sounds like your husband was not monitored close enough. Ive had much experience with anti depressents. It changed my life from a living hell to a peaceful one. However, changing meds can be very dangerous. I KNOW. It will make you out of your mind. I climbed the walls when I tried to change meds. It is my professional opinion as a nurse that when coming off or changing antidepressents one should be extremly closely monitored. Like on a weekly bases if not hospitilized. If anyone out there is going through this please please talk to someone about what your feeling and dont let anyone make you feel bad about yourself or dismiss what you are going through. If you think your doctor is not taking good enough care of you and is not listening get another doctor stat. dont wait. speak up. it may save your life. Again I am so so sorry this happened to you
Unless you have personally experienced depression and taken antidepressants, you are not qualified to weigh your opinion. The symptoms can be very insidious. Picture Charlie Brown. Each time, he doesn't see it coming until Lucy jerks the football away again. Mine began as post partum. I had three little boys to raise, one, an infant. there was no time for psychotherapy, exercise, etc. I have been on them ever since, and "the baby" is 35! The longer you let depression go untreated because you are in denial, the more likely depression is to become chronic and intractable. Joanne's opinion illustrates the classic stigma surrounding mental illness. Patients at the point of suicide should be hospitalized. Why wasn't he?
Antidepressants alter brain chemicals. If a person is depressed because those particular chemicals are out of balance, antidepressants will help them. But, what happens when a person's brain chemicals are not out of balance? Perhaps depression is caused by a life situation or a hormone imbalance like a thryroid problem? Common sense should tell you that playing around with those people's brain chemicals is playing with fire.
A surgeon, at my family's request, put me on antidepressnts days after major cancer surgery. Apparently, dealing with pain, disfigurement, and permanent limitations were not adequate cause to feel depressed in their eyes. It was HELL! My only prayers were to DIE rather than recover! Somewhere in that fog of lost days, I remember standing in front of the medicine cabinet and wondering if there was something in there that if I took a whole bottle of would kill me. I began having panic attacks. I came to enough sense to stop taking them. It was also HELL to stop and I had been on them a very short time at a very low dose.
Yes, there are people who benefit from antidepressants. But, surgeons, GPs, and other non-psychiatrists tend to hand them out like candy, often to people who need a listening ear and a box of tissues. I have had two counselors who specialized in cancer patients, my support group, and several friends who have been through cancer all tell me that my reactions were and are normal and that I need time to grieve and adjust to my body changes. Had I stayed on the antidepressant, I would simply have delayed that process.
JoAnn, I am sorry for your loss. Your story is an example of why antidepressants should be used with caution and only as a last resort, not as a quick fix. They do have warnings about suicides with young people who use them, but I suspect that if they actually took reports like yours seriously, they would be putting out warnings of increase risk of suicide for all ages, not just the young.
JoAnn, I too am very sorry for your loss. I couldn't agree with you more. I was put on Seroquel a couple of years ago when I was living in NJ. Every time I opened my mouth to this Doctor my dose was increased. I began loosing chunks of time. If I was at home(I live alone) it wasn't that noticeable. Something very specific would have to happen for me to notice that I had lost some time. What really really scared me was when I was driving back home from visiting my Daughter and other family members on Long Island. I would take the Verrazano bridge to Staten Island and so on. I remember driving onto the bridge and I remember paying the toll. After paying the toll I made a uturn and drove 50 some miles back to eastern Long Island. I have no idea why I did that and worse I don't remember the drive. That scared the c--p out of me. I personally think that PCP's should not give antidepressents, they don't know enough about them. My depression is situational not chemical. Changing my chemistry is not going to change my situation. I have tried other antidepressents over the years. They have never done anything positive for me.
I went to Synthroid from the generic because I swear the doses weren't even. Of course Synthroid kind of sucks anyway, but at least I wasn't getting different doses different months/days as I was with generic.
Absolutely. They've known for decades Synthroid has to be done DAW, at least every single GP doctor, endocrinologist, etc. who has prescribed them in my family...
It is just another example of how screwed up the Medical Industry is! A high school chemistry student can tell you if two compounds are different, then they are not going to work the same!
Joann I am deeply sorry for your lost : ( I know the future will have a manny sunshines. You see after the storm the sun is always brighter. As for generics if you compare the price difference from the original drug there has to be cuts somewhere and maybe thats where the quality is being compromised. I've had to go back to the original drug for my high blood presure. There is a saying,"all that shines is not gold"!
Joann - I believe what you are saying about your husband not being himself after taking the medication. I was on Prozac when there was many people that attributed it to suicide. It worked wonders for me. Then I stop taking it to see if my depression would return (see if it was a chemical imbalance or life situations). My depression came back and when I got back on the prozac the 2nd time - what a difference!! It was truly a mind controlling, weird, experience. Had I not been on it the first time, I would not have known that what I was experiencing was not normal. If you have not had this experience it is hard to explain. God bless you and your family.
I take nothing but generic drugs for high blood pressure, Atrial Fibrillation, so forth and they ALL work just fine. As a retired pharmacist I have dispensed tons of generics over the years. No problems with them in a hospital setting or a retail setting. Any product can be recalled including cars, foods, brand name expensive Rx drugs, dog treats, and others.
I have also taken many generics with no issue. But, in the case of Wellbutrin, there have been years of claims that the generic form of the drug is not absorbed into the bloodstream at the same rate as the prescription form. While the active ingredients may be the same, it is entirely possible there is something in the inactive ingredients that is messing with the absorption rate. Speaking as someone who suffered heart palpitations while taking Seldane (later removed from the market due to cardiac death), which ended up being attributed to my drinking grapefruit juice, which increased the absorption rate of the drug, there is often more going on here than just the active ingredient and dosage level.
I haven't been real happy with the generic Wellbutrin either. It doesn't seem to work as well, so the dosage was increased but it still doesn't seem like it's either formulated as well or if the batches are consistent. With Wellbutrin, if I missed a dose, I could tell within a few hours. With the generic, missing a dose doesn't have anywhere near the same impact since the full dose doesn't work that well anyway. Insurance won't cover the label drug and the difference in price is too much for me to cover. So, taking a half-assed version that is all my insurance will allow and that I can afford beats paying an arm and a leg or not taking anything at all. The generic drug maker and the insurance company are the winners and the doctors and patients are the losers.
The pharmacists hear these complaints all the time and they have to give the politically correct response through their employers that generics use the same chemical composition and are equivalent, but off the record most of them don't feel that way and view many generics as cheaper knock-offs that often don't work as well.
Just ask yourself, if there are multiple versions of analgesics that contain the exact same active ingredients and yet most people feel that some seem to work better for headaches or muscle pain that others, then why would that be any different for more complex types of drugs?
Mike - my doctor wrote numerous letters to Medco who then greatly reduced the price of name brand Wellbutrin. Ask your doc to do the same - if they follow the procedures set forth by your prescription company, you will get the name brand. Especially after this latest article - run,don't walk, to your doc. The generic absolutely does not work.
What's the label Wellbutrin like, Mike? I'm taking Actavis's generic bupropion XL right now and it seems to be working OK, but there have been other months when I've gone to pick up a refill and the pharmacy has filled my prescription with a different off-brand instead - a pharmacy tech told me that they maintain supplies of two different generic versions of it and tend to use whichever one has the most left (and will purchase a different off-brand instead if it's cheaper that month).
I don't know what to ask the pharmacist or if I should even bother. I'm getting along pretty well, but I'm starting to think this is as good as it's going to get.
..........and I take a generic ritalin. The Danbury generic works quite well. It wasn't until I had the prescription filled at Walgreens that I realized the generic dispensed at the pharmacy across the street is crap. I could take one and throw it over my shoulder. Is it cheaper? Or someone at the lab where it's made sneaking the active ingredient out the back door and selling it on the black market? Most of this is sold for children. A child isn't gong to know the difference or be likely to complain.
I was put on the generic Wellbutrin after having been on the "real" Wellbutrin for a couple years. I was a total witch after starting the generic but thought it was excess stress due to yet another move. New doc told me in summer of 2010 that the generic didn't work like name brand. Put me back on name brand and I'm no longer a witch. Have been fighting Medco since starting back on name brand - looks like they owe me big $$ back. Why did it take Fed Govt over 2 years to pull off shelves????
It is about time. I had the name brand for a while and then when I tried the generic I had all sorts of problems. Luckily my doctor writes it as name brand only! Nice of the FDA to screw this up on the first review - how many users have suffered from a faulty drug when they didn't need to.
And how long will consumers have to wait to find out what other generics don't quite work the way our insurance companies insist they do, as these companies are forcing us to use the generics or pay through the nose?
The generic Wellbutrin is spelled "bupropion" not as spelled in the story. Hopefully this isn't confusing your readers.
David: Bupropion is sometimes marketed as budeprion, but it's the same chemical (bupropion hydrochloride).
My local pharmacy switches between providers depending on who has more affordable drugs - this month's supply is from Actavis. I'm not sure if Teva was ever in the mix, though that would explain the seemingly random spikes in anxiety some months. I'm definitely going to ask the pharmacist about it the next time I need a refill. I have no doubt that bupropion saved my life (and I'm not exaggerating about that), but if sticking to the generic from one manufacturer eliminates that one very irritating side effect, sign me up.
I had been taking the 150 xl generic pill for a long while and my doc upped my dosage to 300 about 4 weeks ago. By week 2.5 I was experiencing 6 or 7 of all the minor side effects and let me tell you they were not minor. Sweating, dry mouth, dry throat/trouble swallowing, nausea and dizziness all day, waking up every 2 hours at night and having VERY weird vivid dreams where when I woke up it was as if I watched a movie all night. I stopped taking the drug 100% about a week ago, on my own. When I saw my doc yesterday she said I made the right choice. Now I'm not sure I will even go back to the 150 dosage. I'm afraid to really. I've never been on the name brand. Now I wonder what I am missing.
Generics are NOT the same. There have been several medications that I have had both the generic and brand names forms of and I can definitely tell a difference. One of them is Lexapro. Another is Lortab (a pain medication). Doctors LIE, the FDA LIES, pharmacists LIE (or are just brainwashed into believing that generics are equal). Insurance companies are bastards that don't want to pay a penny more than they have to. They couldn't give a @!$%# less about us.
Teva needs to be inspected thoroughly. I had problems with breathing when I was on Teva's generic form of Ambien. It was so bad, I was hospitalized. First, the Doctor's blamed my heart. Nothing was found wrong so then they said to check for mold. I told them, but it was disregarded that I had noticed that Ambien seemed to be a trigger. I decided to experiment on my own, so I went to another pharmacy to get Ambien. It wasn't made by Teva. The problem disappeared. I went back to my usual Pharmacy the next month and the problem reoccurred. I told the Pharmacist. She reported it to a government department. They contacted me. The end result (as I was told): Teva's generic form of Ambien was removed from the market. I think that there is a huge disservice to Americans having to take the generic pills. We need to check what the Lobbyists have promoted resulting in ill health for Americans.
I don't want to put a blanket statement across generics because they can help so many folks who might not otherwise be able to afford their prescriptions. But more and more, we are all seeing the differences. The formulas may be the same but the way they are put together is different. For example, some generics are so tightly pressed, for example, they pass through without melting. Time-release coatings are a giant crap shoot...etc.
Add in the multiple companies involved in making the generics...Generic or name-brand, never ever trust the testing-wolves guarding the henhouse X 10! And RX companies now moved a lot of testing to third world countries to boot.
All rather scary. So, where we can, try to add in other methods, like exercise, talk therapy, etc. in conjunction with RX for depression and hopefully, be able to lower one's doses over time with careful supervision, of course.
first off...MSN should get their info correct. The generics name is buPROPION. second...this is the very same drug I take every day and have been for years. The trade vs generic has made no difference to me. Everyone's body is different as well as their minds!
JoAnn,
My deepest sympathy for your loss. As someone who has been treated for depression, and have been helped by meds and therapy, not every person has the same chemical composition in their brain. Generics work for many, but others do require the name brand because of the way the generic version is compounded. Allergies, reactions, or suicidal thoughts can be side effects that truly make the patient feel they are at wits end.
I hope that you and your family can find compassionate therapy to help you come to terms with your loss.