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Mary Shomon

Mylan, Maker of Generic Thyroid Drugs, Under Investigation by FDA

By July 28, 2009

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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 is, of course, in full spin control mode, pumping out press releases saying that they're not to blame, and so on, as they've watched their stock prices tumble more than 10% since the news came out on Sunday.

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.

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Comments
July 31, 2009 at 3:34 am
(1) Liz says:

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.

July 31, 2009 at 6:35 am
(2) J says:

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.

July 31, 2009 at 7:51 am
(3) esssie says:

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.

July 31, 2009 at 7:54 am
(4) Jane says:

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.

July 31, 2009 at 8:28 am
(5) Susan says:

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.

July 31, 2009 at 9:16 am
(6) Debi says:

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!

July 31, 2009 at 10:50 am
(7) Lisa says:

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?

July 31, 2009 at 1:56 pm
(8) Sue says:

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)?

July 31, 2009 at 4:20 pm
(9) Christine says:

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!

July 31, 2009 at 4:44 pm
(10) Christine says:

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

July 31, 2009 at 6:35 pm
(11) Christina (Maryland) says:

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.

July 31, 2009 at 9:06 pm
(12) Dale Clementson says:

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.

August 1, 2009 at 12:21 pm
(13) Carol says:

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.

August 2, 2009 at 6:05 pm
(14) Rhonda says:

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.)

August 14, 2009 at 1:34 pm
(15) Jenn says:

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.

August 28, 2009 at 3:58 pm
(16) hoodia says:

Nice but i think something is missing.

March 17, 2010 at 7:24 pm
(17) Angela in Minneapolis says:

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..

March 21, 2010 at 4:46 am
(18) marysue says:

My Walgreens said they would order the Paddock for me when I said the mylan was crap. Just FYI-

March 21, 2010 at 12:02 pm
(19) Ck says:

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!

December 3, 2010 at 7:48 am
(20) Cindy C says:

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!

August 1, 2011 at 1:05 pm
(21) Susan says:

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?

March 2, 2011 at 12:08 pm
(22) Cathie says:

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.

May 3, 2011 at 11:42 am
(23) Katie says:

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.

October 1, 2011 at 12:43 pm
(24) Shalene says:

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!

October 31, 2011 at 7:52 am
(25) Michele says:

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!!

March 23, 2012 at 11:26 am
(26) Cathie Kent says:

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.

April 19, 2012 at 1:47 am
(27) katherine kubica says:

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.

April 21, 2012 at 10:53 am
(28) Cathie Kent says:

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.

June 19, 2012 at 9:15 am
(29) Mary says:

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….

July 30, 2012 at 5:45 am
(30) Christy says:

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!!

August 7, 2012 at 7:01 pm
(31) Stevi says:

Where can I find a pharmacy that will order my levothyroxine from Paddock Laboratories?

October 2, 2012 at 7:44 pm
(32) Erica says:

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 Ė 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 Ė I bet she has the best.

October 22, 2012 at 1:21 pm
(33) j says:

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.

November 19, 2012 at 11:02 pm
(34) Mary Anne says:

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.

January 3, 2013 at 6:36 pm
(35) Dave says:

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.

January 5, 2013 at 2:33 am
(36) davida says:

I take mylan levothyroxine and have for years. zero problems. perfect TSH level, everytime.

April 15, 2013 at 9:49 pm
(37) jp says:

I’ve been taking Mylan levothyroxin since my thyroid was removed. No problems so far and my TSH is 0.25.

August 3, 2013 at 7:54 pm
(38) Emily says:

Kaiser pharmacy switched my levothyroxine prescription to Mylan last winter. I live in a warm, humid climate, so I keep the bottle refrigerated and only place one weeks worth of meds in my pill box. I never had problems with this method of storage with other brands, but by day 4 in the pill box, the Mylan levothyroxine begins to crumble on its own or when I touch it. I’ve been feeling hypo for many months but thought it might be something else. Now I suspect it’s the Mylan. I haven’t had TSH checked since they switched me to Mylan, but I’ve recently read that TSH should be checked within a couple of months of brand switching. I’m due for my annual checkup and TSH next week and plan to ask for a different brand.

August 22, 2013 at 4:46 pm
(39) Joan says:

I switched pharmacies, and did not even think of checking the source. I am having some of the same problems thee folks had, and I am going to change labels as fas as I can.

THERE OUGHT TO BE A LAW that the pharmacy HAS TO ALERT YOU WHEN IT IS CHANGING THINGS.

September 1, 2013 at 3:07 pm
(40) Emily says:

Re: my post (#38), turns out what I was feeling was hyper not hypo symptoms. I had my TSH checked and it had dropped significantly on the Mylan brand, same dose. My doctor told me other patients had the same reaction (and the same crumbling problem too) when switched to Mylan. No other brands are available in this rural area, so my doctor lowered my dose, still Mylan. The new pills began to crumble within 2 days. I just contacted my doctor and filed a complaint with the FDA. I am so ANGRY!

January 11, 2014 at 3:33 am
(41) Michele S. Banker says:

I was placed on 25 mcg of levothyroxine by Mylan on 12/15/2013 because of the results of thyroid blood tests – low functioning. Over the course of 4 weeks, my significant fatigue lessened and I experienced better energy levels, but not yet back to my normal levels of energy and activity. I felt a bit itchy , but thought my skin was ‘just’ dry. My doctor decided to increase the dose to 50 mcg. Within a week, my entire skin felt like pins and needles – everywhere. Contacted physician who said that she had never heard of such problem but to decrease dose back to 25 mcg. The pins and needles decreased for a while (about two weeks), but now has returned to the same level of discomfort as when i was on the 50 mcg. This is totally unacceptable. This manufacturer needs to be STOPPED from manufacturing this medication AND patients be allowed to get thyroid medications that HELP NOT HARM them. I intend to contact my physician and insist on BRAND NAME ONLY. I can not continue to feel this way. FDA is required to PROTECT and PROMOTE the health of Americans; allowing Mylan to manufacture levothyroxine is counter to your mandate.

January 28, 2014 at 2:18 pm
(42) Chris says:

Kaiser switched me to Mylan when Levoxyl became unavailable. This year has been very bad as far as heart and sleep related issues that began immediately after being switched to Mylan. Levoxal should be available again in March 2014 and I can hardly wait.

March 6, 2014 at 4:46 pm
(43) Kathy says:

I switched pharmacies after a recent move and was given Mylan levothyroxine. I started feeling exhausted all the time, my hair was falling out, and I was gaining weight. I went to the doctor for bloodwork and she gave me samples of brand name Synthroid to try for 30 days. I started feeling like myself again. No more Mylan for me!

March 24, 2014 at 4:38 pm
(44) Emily says:

Update to my post #40. Mylan replaced my crumbling pills and pharmacy gave me desiccant to store with the pills, so now they aren’t crumbling . Kaiser doc encouraged me to try again at a lower dose since Mylan is stronger than other brands and my TSH was too low (.02), so I went from 112 to 100mcg/day, but TSH went up just a little to .08 (still a little low for me), so doc said to take a 1/2 pill less per week (@ 93mcg/day) in hopes of getting my TSH up to @ .1-.15 (my TSH has to be suppressed due to thyroid cancer). 3 mos. on that dose and TSH went up to .66 . Mylan seems very unstable. Talked to my doc and I am switching to NatureThroid this week. No more Mylan for me either!

March 30, 2014 at 8:46 am
(45) Julia Arena Miller says:

I am sitting here crying as I read all these posts.
I have been taking this generic drug for over 12 months when I got switched last year without a discussion by Express Scripts.
I have no thyroid because I had throid cancer.
I count on my medication.
For the last year I have gained 8 pounds, lost about half of my hair, felt tired and have been treated for borderline rheumatoid arthritis and borderline lupus, I am cold all the time, my skin is dry and looks like lizard leather. I am having trouble with tendons in my hands, trigger thumb and fingers.
I AM FURIOUS>
I thought I was going through menopause but I am going through medical medicinal torture in stead.
My health plan switched this year to Caremark and they called me to ask if I wanted synthroid since they felt that the generic wasn’t good enough so they were offering the namebrand drug at generic price.
I have been on synthroid for 6 days and I already feel a huge difference. My hair stopped falling out!
I AM STILL FURIOUS!
I hate Mylan.
PLEASE DON”T LET ANYONE GIVE YOU GENERIC DRUGS!

April 1, 2014 at 3:23 pm
(46) Julia Arena Miller says:

I was switched fro Levoxyl to Mylan generic L-thyroxine last summer without being told by Express Scripts and I have gradually become so sick with all the symptoms of hypothyroidism. I battled thyroid cancer in 2002 and fought to get my levels to a point that I would not feel sick anymore but this generic drug has made me feel like the day I had surgery again. Half my hair has fallen out, unexplained bruising, tendonitis, carpal tunnel, fatigue with napping during the day and can’t sleep at night, constipation, bloating, high blood pressure, depression, shortness of breath, etc. Went to doctor and had blood work and my TSH levels are at a point as to compromise the suppression of my cancer. Doctor has confirmed that the generic drugs many times are not as effective and you will be left with symptoms and in my case exposure to the possible return of cancer. I would be furious but I am too exhausted to feel the emotion. It will take 6-8 weeks to get back to normal on Synthroid. Wish me luck! If you are on generic thyroid medication I urge you to change immediately.

April 2, 2014 at 12:24 pm
(47) Annie says:

I appreciate all of this information for all or you. I was given a generic thyroid that falls apart as soon as it gets wet. I can hardly swallow it before it falls apart. I am really upset. I am so bloated and have gained about 3 pound in the last few weeks since starting this pill. I want to go back to Synthroid, but it costs almost 40 a month. I am really angry. I even had a dream about the pill and am worried of it’s possible side affects. I thought I’d google and see if I was being crazy or if this was a problem with other people. I have got to go back to Synthroid .

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