Urge the FDA to ensure the effectiveness and safety of deadly generic drugs!

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I have had PTSD since I lost my 13 month old daughter to a drowning accident Christmas day of 2002. I suffered another trauma in 2009 that only exasperated the PTSD (Post Tramatic Stress Disorder). I also suffer from Bipolar Disorder, which has been well managed for years but, because of the PTSD, Wellbutrin was added to my mood stabilizer to help with the anxiety, flashbacks and depression. So, like so many others, prescription medications have helped me live a somewhat normal life. I have been taking the generic form (Bupropion) of Wellbutrin XL for many years now, only because my insurance won't pay for the brand name, which is $1800 a month. The generic Bupropion XL 300mg pills I take are small and round and made by Par Pharmaceuticals. My pharmacy started getting the drug, that I've taken for years, from a different manufacturer (Cipla USA Inc.) without notifying me. I only noticed because these new pills were oblong and larger. I did not think anything of the switch because I have always been told that the generic is the same as the name brand, just cheaper. I took one of the pills from the new manufacturer and within hours I started experiencing extreme anxiety, rapid heartbeat, muscle cramps, elevated blood pressure, headache, shivering, "brain zaps"! It was a horrible experience, and I truly did feel like I was going crazy! I can easily see where it could send someone that is already unstable over the edge! My doctor and the pharmacist were not surprised at all by this reaction from just switching drug manufacturers! I have to have my pharmacy always make sure to order the original generic brand for me now, while they are still carrying what is obviously an inferior quality drug (and I have since discovered that ALL of the Wellbutrin, and many other generics of brand names are inferior). Since that experience I've read and heard about thousands of people experiencing bad reactions from the generic form! Patients are saying that only the name brand medications work. They say that the name brand drugs do not have the horrible, sometimes life threatening and suicial/homicidal, side effects that the generics do. I have even had more of my own awful experiences (serotonin syndrome) with other generic medications since. This is crazy and dangerous! Patients cannot afford the drugs that can actually help them, and possibly put themselves at greater risk by taking the generic forms. This affects us all! Anyone who buys generic drugs is taking an added risk by not having the option to take the name brand. This is life or death for so many people already suffering from very serious conditions.

  • Generic drug companies are in the supply chain management business, not medical research. They make cheap products that are “close enough” to the originals to be approvable under an ANDA, usually through a network of off-shore manufacturing partners and loosely regulated commodity-type suppliers.
  • The FDA mandates that generic forms of prescription medication contain the same active ingredient as the brand name, but allows the generic product to have as much as 20% less of the active pharmaceutical ingredient. Also the agency allows the generic version to use different inactive ingredients, including binders to hold the pill together and time release agents to disperse it.
  • That dissolution process was important with Wellbutrin XL and its generic forms because they are "extended release" drugs. Every time-release drug has a mechanism to distribute the active ingredient into a patient's system. The generic forms aren't required to have the same mechanism as their brand name.

"What we found was shocking," said Dr. Tod Cooperman, the president of ConsumerLab.com. "you're getting a burst of medication coming out very early on with the generic that you shouldn't be getting." -ABC News

- 2006, The first generic versions of the popular anti-depressant Wellbutrin XL were approved by the FDA. The drug comes in two dosage strengths, 150 milligrams and 300mg. The 300mg dose is generally used for patients with more severe depression and anxiety and patients who don’t respond to the lower dose. Almost immediately, the FDA started receiving reports from patients that claimed the 300mg dose was being associated with side effects and reduced efficacy.

- 2007, According to The Associated Press, an analysis of Wellbutrin XL and Budeprion XL 300 by ConsumerLab in 2007 first indicated the generic released its active ingredient much more quickly than the brand-name drug.   -DrugWatch.com

- 2012, The FDA finally admitted that the generic of the popular antidepressant Wellbutrin XL is not as effective as GlaxoSmithKline’s original drug. New data showed that Budeprion XL 300 does not release its key ingredient correctly. The 300 mg dose of generic bupropion, sold under the name Budeprion XL and made by Impax Laboratories and Teva Pharmaceuticals was removed from the market because it didn't work as it should. The move does not apply to the brand name version of the drug, Wellbutrin XL, or other generic versions of bupropion. But the FDA asked four other drug makers to test the 300 mg strength of their generic versions of bupropion to make sure they work properly. The FDA's action was based on a study it conducted in 24 adults that found generic Budeprion XL 300 mg is not released into the bloodstream at the same rate and in the same amount as branded Wellbutrin XL 300 mg. This means Budeprion XL might not deliver the same antidepressant benefits as Wellbutrin XL. And it could explain reports from people who said their depression symptoms worsened after they switched from Wellbutrin XL to Budeprion XL. -Consumer Reports

- 2013, The FDA issued a long-awaited report on the quality of a generic antidepressant. In October 2012, after unceremoniously pulling Teva's generic form of the drug the FDA required all generic forms of the long-acting 300 mg formulation to be tested to see if they were identical to the brand name Wellbutrin. The Watson form was deemed not therapeutically equivalent to Wellbutrin XL 300. The drug was voluntarily withdrawn. -peoplespharmacy.com

- 2013, We get over 80% of our active pharmaceutical ingredients from abroad, much from India and China. A top drug regulator in India makes a statement regarding inspections of drug suppliers: “If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those. We are not the US, the infrastructure and resources available there are much different from those in our country. Our priority is to make medicines available and affordable to all.” He also went on to say, “We don’t recognize and are not bound by what the US is doing and is inspecting…the FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver.” BusinessStandard.com

- 2015, The FDA announced that the 300mg generic version of Wellbutrin XL manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals was being recalled because it did not work. And this wasn’t just a problem with one batch – this is a problem that has been going on with this particular drug for four or five years, and the FDA did everything it could to ignore it.

The FDA apparently approved this drug – and others like it – without testing it. The FDA just assumed if one dosage strength the drug companies submitted for approval works, then the other higher dosages work fine also. Forbes - A Drug Recall That Should Frighten Us All About the FDA

Janet Woodcock, the director of the Center for Drug Evaluation and Research at the FDA, told ABC News that the 300mg version wasn't tested separately because "there was concern about testing the generics in normal volunteers. We had had seizures reported, and we were worried that we would be unethically exposing volunteers," she saidABC News - Questions Raised Over Brand Name Rx Drugs vs. Generics

-2017, We had hoped that the problems with generic Wellbutrin (bupropion) were behind us. Officials at the FDA seemed more vigilant about approving this generic product. Sadly, we are starting to hear from readers again that they are experiencing problems. We alerted the FDA to problems with generic Wellbutrin (bupropion) back in 2007. It took five years for the agency to acknowledge there was a serious problem with some slow-release bupropion formulations. Although these drugs were removed from the market, we have continued to receive complaints about certain generic products. The FDA doesn’t test samples submitted by individuals. - Peoplespharmacy.com -Problems with generic wellbutrin bupropion, not again!

  • Patient experiences:

-"I do believe that the antidepressants are responsible for the suicides. I had this happen to me taking Wellbutrin. I was taking Watson 100 SR . I began being sick at my stomach becoming very very scared and fearful. I didn’t realize at first what was happening . The more I took and the longer I took it the more depressed and suicidal I got. Then I got the 75 milligram Apotex brand in the first day I took it I knew something wasn’t right. I was almost hysterical, crying, wanting to die. I finally had it compounded thinking that would be better and the same thing happened. When I went to increase the dose thinking that I wasn’t taking enough that I became much worse. Too scared to leave the house and very very suicidal. Until it happens to you it’s hard to understand. When it is caused from the medication the feelings are so strong. It’s because the medicine changes your brain you become very depressed with no reason to live. These drugs are very very dangerous! That was two months ago and I’m still dealing with the anxiety which I never had before taking these meds and suicidal thoughts. It did something that changed me. This was three different generic brands of Wellbutrin !!! If consumer labs can test these then why can’t the FDA? Every one of the generic wellbutrin should be pulled from the market until the FDA test each one instead of letting the company test them and submit the report." - Helen

-“Within the last 2-3 weeks of taking the same dosage, but a new manufacturer, I am having suicidal ideations. These thoughts are persistent. I have never considered thoughts such as these…ever! This manufacturer was just approved. It’s an oblong, white pill.” -John

-"Over the years I have taken several different versions/brands of generic wellbutrin xl, none of them was ever 100%. It generally changed when the pharmacy just switched with out letting me know. However I have never had any real issues until about a year ago when I was switched to a white pill apparently made by watson.

I began having severe heart issues, high blood pressure, serious anxiety, etc. I didn’t put the two together until 6 months after I had been to the cardiologist several times. I never had any issues and previously wasn’t aware of the “allowances to generic makeup”. After stoping the medicine I felt 80% better within a week and did some research only to find that there are 13 additional inactive ingredients in the current watson version than there are in brand name, 7 additional inactive ingredients than the previous version of watson and 9 additional ingredients than the Teva/Par version!!! - K

-“My Wellbutrin XL 300mg was changed to bupropion and within 3 months my family was concerned. I was showing traits of when I first broke down. I called my doctor, went in, took the bottle with me. She cancelled that immediately and put me back on Wellbutrin and told me to always make sure every doctor put “DAW” (dispense as written) on further prescriptions. Within a few weeks I was doing fine.

"Since then I question every generic as there is not enough info as to where it is made, what country made it, what was in it, etc. Why should we depend on foreign countries to take care of our basic medical needs when they are not as developed as this country is. That is turning our lives over to questionable facilities.” - Carol

-"I found the best generic “FOR ME” is a round, coated tablet with the imprint “A 102” I have gotten friendly with my pharmacist, due to the issues I’ve had over the years, she knows “A102” is the only one I can take. She works hard to make sure I’m taken care of. She tells me there are several different generics on hand in the pharmacy. They typically grab the 1st bottle on the shelf & fill the script.Find a pharmacist you feel comfortable talking to & explain what’s going on. My reactions to another generic was SEVERE! It’s OVAL & it is NOT coated. I don’t recall the imprint.I became severely depressed, almost immediately & extremely suicidal in less than a week. This has happened 3 different times, over many years, before I figured it out. There is definitely a difference when it come to generics!"

-"I have tried the Sandoz manufacture brand and its awful. The first night I had ringing in the ears and dry mouth. I also started off with a shocking pain in my knee. I cut it in half and was having these phantom itches on my back and then hair loss. I'm trying to find a pharmacy that carries the Mylan brand. I also started getting huge pimples.. Now my immune system is being compromised with sore throats and cold sores. Not good." - Aluviel

  • This is not just a problem with psychiatric medications, it's all generic forms of the brand name drugs that can be inferior and/or cause alarming side effects:

“My daughter started having grand mal seizures at 10 years old in her sleep. Despite many tests, they could never find the cause of her condition. At first she was only having a few seizures in her sleep lasting between 20-60 seconds. When she was around 13 the seizures were happening more frequently, about once a month instead of a few times a year.

“At this time I decided to put her on meds. They started her on Keppra 500 mg twice a day. No seizures for 25 mos., not one. We thought we were in the clear. Then the generic came out and the insurance company will only pay for the generic because of course it all comes down to money.

“The pharmacy informed me there is no difference between the generic and the brand and just switched her without even notifying or asking the doctor. Since then she has been having relapse seizures. Every month the pills are different shapes, sizes, and colors. My neurologist informed me there are 28 different companies that manufacture this drug and none of them can be 100% identical. The doctor is very adamant about the generics being responsible and he is outraged by this. He has many patients experiencing the exact same thing with the generic form of Keppra." -E.P.   

  A quick google search will find thousands more of these personal stories. Despite what the big pharm companies and the FDA want you to believe, this is real and it can happen to anyone.

*** Please ask the FDA to Protect us from these drug companies and sub par manufacturing standards overseas and assure our safety when taking medications we so desperately need by testing the generic substitutes as stringently as the brand names. There has been no incentive for companies to actually produce bioequivalent drugs or pure pharmaceuticals. Systemic violations have been ignored or undetected for years. Generics should not have less active and different inactive ingredients, including binders and time release agents, than the name brand drugs. If we cannot get the brand name psychiatric medications we need, due to the incredibly high costs, then they should ensure the quality, effectiveness and safety of generic drugs before allowing them to be given to patients who trust the Food and Drug Administration to do it's job.

 

Notify the FDA of any adverse side effects when using drugs and devices the agency regulates by reporting them online to MedWatch, or by telephone at 1-800-FDA-1088.

Please, if you are feeling suicidal call 1-800-273-8255 or 911 immediately

 



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