The FDA insists that all generic drugs sold in the U.S. are “identical” to their brand name counterparts. Visitors to this website disagree.
The latest controversy surrounds generic sertraline (Zoloft). This antidepressant is taken by millions of people. The reports we are getting make us wonder how good a job the FDA is doing at monitoring foreign-made pharmaceuticals.
The FDA insider tells me that the agency has not seen much in the way of complaints about generic sertraline, but we certainly have.
Reports of Generic Sertraline (Zoloft) Difficulties:
“I noticed this last month when picking up my Rx refill that the sertraline (Zoloft) tablets were different, but I know there are several manufacturers of medications, so I didn’t think much of it. Now, after almost a month on the new generic sertraline, my anxiety is at another rise; panic attacks are prevalent and I had no idea until just now researching this drug why thus was happening.
“I guess I’ll be switching to a different pharmacy. And trying to ride out the next few days in hell…”
“The generic sertraline from Aurobindo made me feel like I was on some sort of ‘speed,’ and it appears that others are feeling some pretty negative side effects as well. I had done very well for years on the Greenstone generic, but within two days of starting the Aurobindo tablets, I began feeling manic and couldn’t sleep at all. I felt like my brain had gone into overdrive.”
“I refilled my prescription for sertraline (the MFG for my drugs went from Greenstone to Aurobindo). I noticed the pill looked different and the MFG seemed different but, I figured it wouldn’t be that big of a deal.
“After 2 weeks of the drug I would go home after work and I wanted to kill everyone. I was so emotional and all over the place. I literally started to feel schizophrenic and not myself. I hated anyone that crossed my path at home, and I would lock myself in my room for hours, wondering what is wrong with me. I just knew I was feeling weird.
“Finally at work, someone mentioned a very similar issue they had where they had a bad reaction to a new generic version of a pill they’ve been taking forever. Going home, I was set to figure everything out, but as soon as I closed the door, I had the worst panic attack of my life. I have had anxiety issues for many years and I have overcome this a million times, but this one sent me to the hospital. I called my mom because I felt strange and I was slurring my words and could only answer yes/no questions.
“My mom came to check up on my and found me face down on the floor having a seizure (ended up being a pseudo-seizure). I was hospitalized for 24 hours. I feel like this is sickening that you can be on the same drug for years and then they’re allowed to switch generic manufacturers without really telling you.”
“I have been on Sertraline 25mg manufactured by Greenstone for many years until Walgreens switched to selling the drug manufactured by Aurobindo in July 2015. I have had the most horrific panic attacks and pervasive anxious feelings since the switch. I have never before experienced such mental anguish, which is chemical and due to the change of manufacturer. (I am fortunate not to have any major stressors to blame.)”
“I have been on Zoloft since 1991. I switched to sertraline as soon as it was available. I have been stable for several years. Since my last refill I have noticed a gradual decline in my mood. I am ‘down in the hole’ again and can’t seem to find a way out. I have even been obsessing with suicidal ideation again. It’s a scary place to be in.
“Situationally, nothing has changed in my life. I am in a therapy, so I feel safe. I am starting to wonder about the effectiveness of my sertraline I was curious if anyone else has had a return of symptoms while taking sertraline vs Zoloft.”
“Recently filled my Rx for generic sertraline and was informed the manufacturer changed (went from Greenstone to Aurobindo). I know from past experience this can be an issue but I was trying to go with the flow.
“Fast forward after taking the Aurobindo for 2 weeks and it was scary how dark my mood/thoughts were getting.
“Walgreen’s actually handled it great when I went in to tell them I was not responding well at all to the Aurobindo sertraline and needed to switch back. They were able to get me the Greenstone manufacturer again within a couple of days but it took another 2 weeks to get it back into my system and start to feel like I was in control of my thoughts again…pretty terrifying really. Overall bad experience with sertraline manufactured by Aurobindo.”
“I had the exact same issue as Jennifer. Sertraline was switched from Greenstone to Aurobindo at Wallgreens. I started feeling anxious, lightheaded, and I had a Vasovagal reaction and passed out at work. After 2 weeks of this I have called Walgreens and they have ordered the Greenstone for me. I have been on this drug for over 10 years and I have never had a reaction like this.”
What’s Going On with Generic Sertraline?
You have just read a few of the messages we have received about generic sertraline problems. We have no way of knowing at this time whether there is a bioequivalence issue like the one we discovered with generic Wellbutrin several years ago. The FDA ignored our concerns for years, telling us that the complaints we were getting were likely imaginary.
We did not give up and many years later the FDA discovered to its chagrin that Budeprion XL 300 was not bioequivalent to Wellbutrin XL 300. Budeprion XL 300 and another generic bupropion were removed from the market because they were not equal to the brand name antidepressant.
The only way we can get to the bottom of this sertraline issue is if people contact the Food and Drug Administration and share their stories. The agency does not make it easy, however. You will need to know the manufacturer, the lot number, the expiration date, and the NDC identifier. Your pharmacist can supply this information if you push her. Here is a link to the Consumer Voluntary Reporting Form FDA 3500 B. You can also report electronically by going to the MedWatch page.
Feel free to report your experience with generic sertraline below in the comment section. Let us know what generic products are working and which might be causing problems.
We will send your story on to executives in the Office of Generic Drugs at the FDA. You will also be able to share your own experiences with others so that they will know what to expect if they too are having troubles with generic sertraline.