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FDA changes label/adverse effects of Synthroid
Questions in the Thyroid forum are answered by Mark Lupo, MD. Topics covered include Goiter, Graves Disease, Hyperthyroid, Parathyroid/Calcium Problems, Thyroid Cancer, Thyroid Nodules/Cysts, Thyroiditis, Thyroid & Pregnancy, Thyroid Stimulating Hormone (TSH), Thyroid Tests, and Thyroid Surgery.

FDA changes label/adverse effects of Synthroid

by Still_Hoping, Aug 27, 2005 12:00AM
I was looking up synthroid recently due to all the complains on this forum about this drug. Although in my drug book palps and increased HR (tachy/arrythmias) are noted as side effects of ALL the drugs to treat thyroid disease, it notes that 'normally' they are found in overdose of the drug (my interpretation: the TSH drops too low for your body thereby pushing you into hyper state),  not usual dosage.  As DrMark noted earlier some are sensitive to this drug and need very slow titration (advancement) of the drug.  I did note that hypersensitivity was one of the adverse reactions to these drugs listed.  

What my 2004 drug book does *not* list as a side effect/adverse reaction however is trouble swallowing (dysphagia).  However - I have seen many folks on here wondering if their treatment is causing their throat pressure/choking (and even, their hair loss!) so I looked this drug up on the net.  

Here is what I have found thus far:  I have yet to find any source saying hair loss is a side effect of these drugs.  DrMark - have you heard of the treatments being inducers of hair loss?

What I *did* find interesting, however, is when I visited the FDA drug site, where they have a site called Medwatch, therein they list recalls, and warnings and label changes and such. For Levo/Synthroid (and I do not know about other forms of thryroid drugs), they HAVE just (this year) changed a requirement for the label under adverse reactions to *include dysphagia* (trouble swallowing).

DrMark - do you have any comments on this new adverse reaction the FDA has on Synthroid/Levo?
Member Comments (3)

by Still_Hoping, Aug 27, 2005 12:00AM
Forgot to add.... the label of Levoxyl (I didn't find synthroid), which is Levothyroxine the same as synthroid is if I understand them correctly; they work the same...  doe say that initially some hair loss rarely may occur in the first few months of treatment but should subside. So aside from that, I have not found any other literature yet saying it is a permanent cause of hair loss and actually this statement by their company (Levoxyl) says it is not often at all that hair loss occurs.  Personally I have been loosing so much (evenly, thankfully) from my hypo I'm not sure I could tell the difference...  As for dysphagia, they label the warning that this drug more or less gets stuck in the throat and causes difficulty breathing, swallowing etc.  They also claim, however, that when take with a full glass of water 'almost' always fixes this situation.

Interesting. So for those of you wish unexplained swallowing in addition to seeing your ENTs and such you may want to make sure you are taking your med with a full glass of water...  

Dr. Mark - I am wondering why they don't enteric coat this drug (and those like it) to prevent it being caught in the throat. It probably slows the release down a bit, but... I have to wonder why they don't do it that way. Any thoughts?

by Mandy44, Aug 28, 2005 12:00AM
How can one tell if they are on generic or not? All my bottle says is Levothyroxine- If you are taking Synthroid or the other one I am assuming it would say it on the bottle? Under side effects on my drug sheet from the pharmacy hair loss was mentioned- It is my understanding though that this stops and hair should grow back after awhile? Also since I just started the meds two weeks ago is it okay to switch back to name brand next month? And which do people prefer the Levoxil? or Synthroid?
Thanks for any info....

by Mark Lupo, M.D., Aug 28, 2005 12:00AM
enteric coating does not significantly prevent sticking in esophagus.  The warning was due to Levoxyl (one brand of levothyroxine) - a few reports of sticking in throat (perhaps due to size/shape - larger than synthroid tabs).  Taking any pill with a 8oz glass of water is recommended.

The hair loss (i think) was reported because it's a common symptom of hypothyroid and hairloss will often lag 2-3 months behing the inciting event.  Also hormone fluctuations could cause hair loss and in turn correcting the hypo may cause transient problems with hair loss.  It's not unique to synthroid.

by dana1218, Apr 18, 2008 08:51AM
A related discussion, Synthroid Overdose was started.

by sue2005, Feb 15, 2009 04:30AM
A related discussion, watch for blurred eye vision from levothyroxine was started.

by Pat539, Jul 21, 2009 05:20AM
A related discussion, Trouble Breathing was started.
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