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