Thyroid drugs recalled, the FDA said in a new warning
The agency says that a problem with prescription pills creates a serious health risk.
Medicines can be a powerful tool for processing chronic conditions, helping to control everything, arterial pressure to persistent pain. One of the most common diseases where prescriptions are effective is hypothyroidism, which affects Five people out of 100 In the United States, over 12 years, according to the National Institutes of Health (NIH). The condition is the most frequent in people over 60 and is more likely to affect women. But if you are one of the many who take pills to manage it, you should know that Food & Drug Administration (FDA) has recalled a thyroid drug compared to serious health problems. Read the rest to see what the agency says in its new warning.
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The FDA has just announced a major recall of a thyroid drug.
On February 1, the FDA announced that IBSA Pharma Inc. had published a voluntary reminder of specific batches of his medication in oral soil solution (levothyroxine sodium). The 27 lots assigned are listed on the agency's advice, including NDC numbers, lot numbers and expiration dates that consumers can use to identify them.
The agency says that doctors prescribe Tiosint-Sol for the treatment of hypothyroidism as a replacement therapy. It is also used in the abolition of pituitary thyrotropin as part of a range of treatments for certain types of thyroid cancer. The FDA describes the drug as "a clear solution, colorless to slightly yellow supplied in a white unit dose bulb, not transparent of 1 milliliter" with the dose resistance identified on each box and the pocket with a distinct color designated at each resistance level .
The company has discovered potential problems with the power of the drug.
Depending on the FDA reminder notice, IBSA Pharma Inc. recalled the medication after finding that the lots in question could be underestimated or inferior to the possibility of resistance than that listed. The company's analysis has shown a slight decrease less than 95% of the amount of sodium levothyroxine in affected medicine.
The agency warns that patients taking the drug with lower dosage could start to feel the immediate symptoms of hypothyroidism, in particular "fatigue, increased sensitivity to cold, constipation, dry skin, swollen face, loss of Hair, slow heart rate, depression, swelling of the thyroid gland and / or gain of unexplained weight or difficulty losing weight. "
In the long term, incorrect dosage could lead to other problems, such as adverse effects on growth and development, heart function, bone metabolism, reproductive function, cognitive function, emotional state, gastro function -Intestinal and the metabolism of glucose and lipids.
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Here is what you need to do if you are currently taking the recalled thyroid drugs.
The FDA reports that IBSA Pharma Inc. is alerting wholesalers, distributors and health care providers on recall. However, the agency advises anyone who is currently taking TiRosint-Sol not to stop taking it without first speaking to its health care provider to discuss a possible replacement. AE0FCC31AE342FD3A1346EBB1F342FCB
Until now, there has been no report of adverse reactions or medical emergencies linked to recalled medicine. But whoever takes the medication that feels that he experiences problems - including enclosures, newborns and elderly patients - should immediately contact their doctor or health care provider. All patients with questions or concerns can also reach IBSA Pharma Inc. by calling the hotline or by contacting the e-mail address indicated in the FDA reminder notice.
There have been other recent medication reminders.
It is not the only recent incident involving the recall of a drug. On December 21, 2022, the FDA announced that Lupine Pharmaceuticals had voluntarily recalled four lots of Quinapril tablets, who is an inhibitor of the angiotensin conversion enzyme (ACE) used for lower the blood pressure in patients with hypertension.
The agency indicated that the tests found the "presence of a nitrosamine impurity", called n-nitroso-quinapril, which was above the level of the acceptable daily contribution (ADI). And while people are generally exposed to nitrosamines in "water and food, including dried and toasted meats, dairy and vegetables", they can increase the risk of cancer at higher levels over the course of time. Patients were invited to contact their doctor or pharmacy while continuing to take the medication.
The authorities reported another drug against blood pressure on October 24, when the FDA announced that New Jersey Aurobindo Pharma USA, Inc. had published a voluntary reminder on two specific lots of his Quinapril and hydrochlorothiazide tablets USP 20mg / 12.5 mg. This example also involved the discovery of the N-Nitroso-Di-Quinapril in the medication, the agency again advises patients to continue to take the medication while contacting their doctor or their health care provider as soon as possible.
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