On February 1, 2023, the FDA announced a consumer-level recall of 27 lots of IBSA Pharma's TIROSINT-SOL (levothyroxine sodium) oral solution because these lots may be subpotent. The company's analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots.
IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Subpotency | FDA.
The FDA issued its Class I designation February 21, 2023. Tirosint-SOL is a prescription drug used as replacement therapy in primary, secondary, and tertiary congenital or acquired hypothyroidism.
This week, the FDA announced that 27 lots of levothyroxine sodium oral solution, used for hypothyroidism, were being recalled due to potentially being subpotent. The FDA announced that pharmaceutical company IBSA Pharma recalled 27 lots of levothyroxine sodium (TIROSINT-SOL) oral solution due to sub-potency.
Yes, it's safe to take levothyroxine for a long time, even many years. However, high doses of levothyroxine over a long time can sometimes cause weakening of the bones (osteoporosis). This should not happen if you are on the right dose. It's important to have regular blood tests to make sure your dose is not too high.
Common side effects of levothyroxine include heat intolerance, a fast heart rate, and diarrhea. More serious levothyroxine side effects are also possible.
Levothyroxine may cause serious or life-threatening problems when given in large doses, especially when taken with amphetamines such as amphetamine (Adzenys, Dyanavel XR, Evekeo), dextroamphetamine (Dexedrine), and methamphetamine (Desoxyn).
An underactive thyroid is a lifelong condition, so you'll usually need to take levothyroxine for the rest of your life. If you're prescribed levothyroxine because you have an underactive thyroid, you're entitled to a medical exemption certificate. This means you don't have to pay for your prescriptions.
Daily levothyroxine (LT4) at a dose of 1.6 to 1.8 μg/kg of body weight per day is the treatment of choice and standard of care, sufficient to restore the thyroid stimulating hormone (TSH) to normal range.
Thyroid hormone affects virtually every organ system in the body, including the heart, CNS, autonomic nervous system, bone, GI, and metabolism.
Experts consider levothyroxine to be the first-choice medication for treating hypothyroidism. This is because it works well and doesn't have too many side effects.
Levothyroxine is sold under several brand names, including Synthroid, Levoxyl, Unithroid, and Levothroid. A generic version of levothyroxine is also available.
A person can go for many years without thyroid hormones. Indeed, people often go undiagnosed for decades despite suffering from hypothyroid symptoms.
It is possible that hypothyroidism is being diagnosed at increasing rates, so that increased case finding may be contributing to the increased number of LT4 prescriptions. At the same time LT4 therapy is being initiated for increasingly mild or subclinical degrees of hypothyroidism.
Official answer. Levoxyl is a brand of levothyroxine, made by Pfizer Laboratories. Levoxyl is an oral tablet that may be given to treat low thyroid levels (hypothyroidism).
IBSA Pharma Inc. announced the voluntary recall of 27 lots of Tirosint®-SOL (levothyroxine sodium) oral solution to the consumer level due to subpotency. Tirosint-SOL is indicated as replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Natural desiccated thyroid (NDT)
(NDT) is a thyroid medication that was used until levothyroxine was produced. Some people have unresolved symptoms on levothyroxine and/or T3 but find NDT improves their symptoms. Read more about Natural desiccated thyroid (NDT).
The Synthroid brand of levothyroxine improved thyroid-stimulating hormone (TSH) levels by a significantly greater margin compared with generic versions of the synthetic T4 (LT4) hormones for patients with hypothyroidism, according to a retrospective claims database analysis presented at the American Association of ...
Levothyroxine levels in the body start to drop significantly after about 6 or 7 days, so you'll likely notice symptoms of hypothyroidism if you miss a week or more of the medication. If you're taking a form of thyroid hormone that doesn't last in the body as long, the symptoms will be even more noticeable.
Too much levothyroxine can lead to hyperthyroidism, which can exacerbate heart issues. Indeed, there is a potential risk of causing more harm than good, especially in people with subclinical hypothyroidism and heart failure.
When you start levothyroxine you won't feel better the next day. You may not feel better in two weeks. But symptoms should start disappearing within a month. After six weeks of treatment, you should be almost completely free of symptoms, assuming you're at the right medication level.
For people with heart problems: Levothyroxine can increase your risk of serious heart problems, such as heart attack, abnormal heart rhythm, and heart failure. This risk is increased if you've already had these problems.
The common clinical signs following thyroxine overdose can either be limited to tachycardia, agitation, nervousness, insomnia, anxiety, tremor [2], or severe features, though less likely, like thyroid storm involving cardiac, neurological, respiratory and thermoregulatory center [3].
Recent studies show that 30%–60% of patients on thyroid medication are able to discontinue it and maintain normal thyroid status [1, 2]. Of course, this isn't to say that everyone should attempt to stop their medication on their own, as it should be done with a healthcare provider's careful supervision.