Mylan, the West Virginia-based drug company that makes a generic levothyroxine medication, and recently received FDA approval recently for its generic version of Cytomel is now the target of
a federal investigation. The Pittsburgh Post Gazette has broken the story of workers at the Mylan's West Virginia plant, who were, according to internal documents obtained by the Post-Gazette, "routinely overriding computer-generated warnings about potential problems with the medications they were producing."Mylan is the world's third largest generic drug company, and makes a number of generic medications. Allegedly, Mylan was involved in falsifying information and altering products, possibly for as long as two years or more. It's not clear if the quality of their products -- which include various generic thyroid medications, among other generic drugs -- was affected.
The U.S. Food and Drug Administration has said that it is now investigating Mylan. Mylan issued a statement suggesting that the FDA investigation was routine, but the FDA took the unusual step of issuing a statement to refute and rebut Mylan's efforts to downplay the severity of the investigation.
The Pittsburgh Post-Gazette is ground zero for investigation and coverage of the Mylan scandal, as you'll see from these links to the coverage.
- Mylan workers overrode drug quality controls, Internal report detailed 'pervasive' practice of ignoring safety procedures -- Pittsburgh Post Gazette, Sunday, July 26, 2009
- Mylan's 'red screen' timeline -- Pittsburgh Post Gazette, Sunday, July 26, 2009
- FDA probing Mylan's actions, Quality control violations were cited in internal report -- Pittsburgh Post Gazette, Tuesday, July 28, 2009
- "FDA refutes Mylan statement" -- Pittsburgh Post Gazette, Tuesday, July 28, 2009
What Should Thyroid Patients Do?
We've always known that many doctors do NOT recommend that thyroid patients take generic levothyroxine from any maker, including Mylan.
No one knows whether there are quality or consistency issues with Mylan's generic T3 at this point. But there is not a great cost differential between brand name Cytomel and the generic liothyronine from Mylan. So, at this point, patients may consider waiting a while to see how this Mylan scandal shakes out before being willing to change over to their generic T3 medication.
Photos: clipart.com
I can tell you from personal experience – the generic version of Cytomel is not even close in it’s effectiveness. My pharmacy just arbitrarily filled my RX with the generic. Within a week, I had gained 5 pounds and felt like total garbage. I would sleep 13-16 hours straight and became clinically depressed. I had my Dr. call the pharmacy for a brand only RX, and was back on track in no time. It’s a shame the FDA lets this stuff on the market.
I have taking the generic levoxyl for about a year…my TSH levels have been bouncing all over the place, ranging from .52 – 20 !!!! (confusing because my thyroid was ablated years ago) Also, yesterday I picked up my Cytomel from the Pharm and found it’s been replaced with the generic also….I’m contacting my doctor right away.
I have been taking the generic Cytomel for several months, but it is NOT from Mylan, it’s from Paddock Labs. Just wanting to say that this particular generic (Paddock) has been working great for me.
My mail-order pharmacy filled my Cytomel script with generic liothyronine at the beginning of June. I couldn’t figure out why I felt progressively more fatigued, began gaining weight, lost hair, etc., as the month progressed. I got more Cytomel about two weeks ago and now I am feeling better.
I am very grateful for this article. When I first started Cytomel. I got just a 30 day supply to see if it was going to work. Then I started getting it in the mail and have progressively felt bad, losing hair, gaining weight, dry skin and my thyroid levels are bizarre. Thank you…I will be investigating this with my doctor.
Another thing to have to worry about! I always have to make sure EVERY time I go to get my Levothroid to make sure they don’t substitute it for Levothyroxine (Generic). I have told the pharmacy everytime to never give me or my mom generic T4 med. Now, I will have to make sure I only get my brand name Cytomel! Good grief!
I wonder if that is why I have been having problems: tired again, hair loss–even after doctor increased my dosage. What is safe then? My pharmacy would substitute Synthroid by Abbott Labs. Is that okay to take?
Wow, I totally agree. It took me less than a week to call my doctor and get him to send in the “non-generic” prescription request. The generic cytomel felt like I was taking a placebo. I am so glad that someone is looking into the company!! Is there any way we can get our feedback to the someone in the investigation (FDA or whoever)?
I was taking Mylan generic Inderal (propranolol, a beta blocker) for Graves’ related heart irregularities and to reduce excess T3 production. The brand name Inderal in regular strength tablets was discontinued several years ago. I did really well on the brand name (Wyeth Ayerst) for 12 years. But what can you do when the brand name is no longer available? You’re stuck with the generic.
On the Mylan brand propranolol, I was having heart episodes several times a week, and that was with normal thyroid levels, controlled by ATDs (AntiThyroid Drugs). Since I pay cash for my prescriptions, I finally found brand name Inderal from Canada. After 2 months on this, I no longer have the transient heart episodes.
GENERICS ARE NOT THE SAME QUALITY AS BRAND NAME, PERIOD!!!
If ObamaCare goes through, I’m afraid we might be forced into these inferior generics (his “blue” pills), so don’t let your guard down. Stay informed!
Sue -
Here’s a link to a form you can use to contact the FDA with questions or comments. I’ve used it before and got a response about a week later:
http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm
Six months ago my pharmacy switched my brand of levothyroxine to Mylan. I started feeling extremely fatigued in a month or two and sure enough when I was tested again, my TSH level had climbed back up. I told my doctor I thought it was because of the brand and he rejected the idea and prescribed a higher dose. Since then I switched pharmacies and they do not use Mylan and I am doing better. Just saw my first endocrinologist and he confirmed for me that you have to watch generics of thyroid meds as well as heart meds and blood thinners.
I got switched to generic cytomel and I noticed that my knees hurt when I stood up. Stopped taking it and my knee pain went away. Got my Doctor to prescribe “dispense as written” for Cytomel and now my knees don’t hurt upon standing.
I have been getting Levothyroxin from WalMart because they offer the 90 days for $10 on generic.
I have been unable to get my dr. at Kaiser Permanente to prescribe Synthroid, which was what I started on a few yrs back, because Kaiser’s policy is to use the cheapest generic regardless of how the patient feels and will penalize the patient who does better on a name brand with higher RX costs.
I contacted WalMart pharmacy in Pleasanton, CA today after reading the article on Mylan labs only to be told that WalMart will not do anything or cares to even consider the current investigation of Mylan labs until the results are completed, say in many months. Meanwhile, those using this medication take the risks involved. I can only state that taking this generic, I have not felt 100% and Kaiser doesn’t care as long as they minimize their costs. It is actually cheaper to fill the RX at WalMart for the same generic than to fill it at Kaiser.
Everyone is individual. When I was diagnosed as hypothyroid a year and a half ago, I was started on generic levothyroxine. I have had no problems with it whatsoever. The important thing if you start a generic levothyroxine is to stay with the same generic companies version once you are stable. This is important to know because not all insurance will pay for brand Synthroid (mine won’t.)
I have Hashimoto’s disease and I was put on generic levothyroxine….personally I feel it was doing nothing for me with the exception I had less heart palpitations…I continued to gain weight..my hair is just as thin…I feel like crap. Now mind you I have more issues than just Hashi’s BUT the meds should have made more of an improvment. Right now it is not even worth the money to fill the scripts… and personally I have felt after all I have been through…no one really cares about we the patients anyways, they don’t have to feel our pain. Doctors don’t even listen to their patients anymore.
Nice but i think something is missing.
Mylan’s T3 is TERRIBLE! All Generics are NOT equal. Walgreens switched from Paddock (which worked great for me) to Mylan without ANY notification to the patient on the refill. They have switched nationally to Mylan. Because T3 is fast acting I could tell within 1-2 days. And it was down hill from there. I had to call around to find a small independent Pharmacy to find Paddock again. I ended up paying for it on my own – insurance company refused – whatever! It’s worth it to feel good.
Check you Rx bottles! Make sure that you haven’t been switched. Call around to find a Pharm that still stocks Paddock.
Good luck everyone..
My Walgreens said they would order the Paddock for me when I said the mylan was crap. Just FYI-
I took the Paddock version of cytomel from July through mid-Feb. and it worked fantastically. I lost 30lbs. and felt fantastic!! Feb. 13th our Walgreens changed to the mylan pills. Immediately my hair started falling out and I started regaining weight.
BLAH!
What a surprise (that was sarcasm)! My doctor put me on this generic 5 months ago. For the past 3-4 months I’ve felt like crap — tired, depressed, listless, gaining weight in spite of constantly dieting to lose weight. I brought it up to my doctor who said “oh, there’s not much difference between Synthroid and this generic” and refused to write a prescription for Synthroid. I just had bloodwork done — guess what? My TSH is way way up and the other numbers are way off too. I now have a prescription for Synthroid even though I’m going to be paying out the nose for it because my insurance will only pay for generics when they’re available. It’s worth it to me! These companies need to be out of business when they screw with other people’s health this way!
Because of cost I went to generic big difference. Weight gain and hugh appetite increase tired and lack of will power for anything, increased of sleep issues feels like rocks in my stomache thyroid and parathyroid surgery(Jan 2011) was promised to feel like a new woman still has not happen and this is the beginning of August. Has anyone else had these problems?
After switching to the generic “Mylan” I developed hives. I could never find anything that caused these hives. I recently switched back to using the Kaiser Permanente pharmacy. They use the brand I had been using for over 20 years before I switched. I decided to switch because my tests have been very erratic since changing to Mulan. Hopefully, my tests will be back to what they were – good things is that the hives are now gone. The prescriptions from Kaiser may cost more but my health and well-being is worth it.
I seem to be the opposite here. Before I was aware of any of this, I started out taking Mylan’s T3. When the pharmacy made a temporary switch to Paddock, within 2 weeks I started getting hypo symptoms. Switching back to Mylan solved the problem.
Now Mylan’s T3 is on “long-term backorder.” I will have to look into switching to brand-name Cytomel or find another generic that’s going to work for me.
Same thing for me. Never had to change doses after two children and ten plus years, but pharmacy switched manufactures and I’ve noticed changes in my sleep at night. Body temperature is cold during day, but I feel I have a fever at night. Depressed and sluggish after three weeks of being switched. Trying to get back on generic mylan brand as soon as possible!
I’ve been doing a lot of reading and IBS-D and came across links to thyroid medications. Turns out it wasn’t some mysterious thing causing the IBS-D, it was the generic Synthroid medication that Walmart was giving me. Levothyroxine by Mylan! Stopped taking the medication for two days to see what it would do…symptoms stopped completely!! Having my doctor write my prescriptions for name brand only!!
I am thrilled to see that Mylan is under investigation. I changed to the generic version of Levothroid several years ago and began having hives several months later. I am not sure why I didn’t read the side effects but I did not. After a bunch of allergy tests, and then bad blood tests, i went back to the pills from the previous supplier. My hives went away immediately and my blood tests went back to normal. It was quite apparent that Mylan thyroid pills were the culprit.
i took this mylan thyroid and lost my voice,hair loss and so much more my blood is all mess up also .i stoped mylan itook this brand by missteak. i now am back on the paddock brand.my blood tests now are geting better.
I was taking Levothyroxine from Mylan for several years (it was an effort to save a few bucks) and suffered from hives – the largest was about the size of a 33RPM record. I went through allergy tests and nothing came out. After having several bad TSH tests I switched back to my Levothroid from by health care provider and the hives went away. Imagine that. And my tests have been good since.
I couldn’t figure out why I’m feeling like I did before I was diagnosed with Hypothyroidism, thought something is terribly wrong, I was feeling so good for while and now I feel worse than I ever did, so I looked at my recent prescription and noticed that it was substituted for the brand prescribed, the generic Tab from Mylan….very upset about this…talk about turning ones life upside down….
I have had nothing but trouble with Mylan’s Levothyroxine! A different doctor changed me to this even after being told I had a reaction years ago. He said they are the same. WRONG!! I have been having chest pain and racing heart on this med. Each pill feels like a different dose. My small pharmacy told me my insurance won’t pay for Synthroid.
I just called Walgreens and they say it’s a lie. I’m going back to the doctor I had before and back to Synthroid. 20 years of NO PROBLEMS on Synthroid and then chest pain and heart issues the first month on Mylan’s crap tells the truth!!
Where can I find a pharmacy that will order my levothyroxine from Paddock Laboratories?
Kaiser just switched to Mylan after Forest recalled their generic. I’m terrified to take it after reading all of the negative reviews so I called and spoke to a pharmacist only to be told “you have only taken one pill – try them for 6 weeks and get tested then decide if you want to take something else.” So much for consumer having a voice or a choice! Both Mylan and Forest seem to be shady manufacturers. Does anyone know what brand thyroid medication Oprah takes – I bet she has the best.
I am 22 yr old male and found out on august 2012 that I have hypothyroid hashimoto. last year august I was 185lbs. this year august I am 227lbs. I have half the hair on my head.
I don’t remmeber the first brand of prescription I was using but I do know my second prescription was a generic mylan levothyroxine. and my third one I refilled on the 19th a few days back is made from pfizer. I found out my endocrinologist had instructed them to use brand only. then how did I end up with generic in the 2nd month? water over the bridge. im glad I stumbled upon this article. Its too early to see how my body will react to pfizer brand. I had been feeling well with the generic, my tsh and my abs levels have dropped dramatically. my abs was over 1100ui now its starting to climb down.
however while taking the generic first 3 hours of taking it I felt terrible. irregular heartbeat, very nervous feeling, and felt as if ny heart is gonna come outta my mouth. I thought those might be the regular side effects of Levoxyl but to that extent its just ridiculous. I don’t feel any of of those symptoms anymore now with pfizer. hopefully my head full of hear will return soon and ill shed the extra 40lbs that I put on in matter of months.
how long did it take you fellas to see some physical changes? I have started seeing the inner changes where my mood is always great and always feel satisfied. I don’t get constipation anymore nor constant heartburn. depressed feeling is also shedding off slowly. I’m talking about physical results? I had a head full of dark thick shiny hair. they have gotten so thin I’m scared to death sometimes. its my 3rd month on this medication.
Kaiser changed me from Levothroid to Levothyroxine manufactured by Mylan. Within 2 weeks I have gained 7 lbs, I am sleeping 10 hrs plus per day, my hair is dry, I am swelling and my period is out of wack! I told the Kaiser Pharmacy that I did not want any Rx medication from Mylan and they told me that this was the only manufacture available. I had negative health impacts when Kaiser changed by Estradiol from the manufacture Barr to Mylan. I complained and they changed my Rx back to the Barr Manufacture. If you are changed to any medication manufactured by Mylan refuse to take it and complain to your physician, pharmacy and the FDA.
I also am a Kaiser member and had to switch from Forest to Mylan recently for hypothyroidism treatment. It is interesting to read comments here. Shortly after switching to Mylan (mind you only 4 days per week of 75mcg changed; the other 3 days were still Forest pills) I developed chronic anxiety’panic, diarrhea, some insomnia, poor concentration, mood fluctuations, some rapid heart rate, and I’ve lost about 10 pounds). Despite these apparent hyperthyroid symptoms my TSH is “normal” though going down (from 3.9 to 3.1 in two weeks). Historically I have felt good actually with TSH’s closer to upper end of normal. Anyway what I’d like to know is if others have experienced feeling awful with pretty clear thyroid related symptoms despite normal TSH on generics. I’m also trying to gauge how important it is to be on name brand medication.
I take mylan levothyroxine and have for years. zero problems. perfect TSH level, everytime.
I’ve been taking Mylan levothyroxin since my thyroid was removed. No problems so far and my TSH is 0.25.