Κυριακή, 25 Ιουνίου 2017

Gluten and Aluminum Content in Synthroid ® (Levothyroxine Sodium Tablets)

Abstract

Introduction

Inquiries from healthcare providers and patients about the gluten and aluminum content of Synthroid® (levothyroxine sodium tablets) have increased. The objective of this study was to measure and evaluate the gluten content of the raw materials used in the manufacturing of Synthroid. Additionally, this study determined the aluminum content in different strengths of Synthroid tablets by estimating the amount of aluminum in the raw materials used in the manufacturing of Synthroid.

Methods

Gluten levels of three lots of the active pharmaceutical ingredient (API) and one lot of each excipient from different vendors were examined. The ingredients in all current Synthroid formulations (strengths) were evaluated for their quantity of aluminum.

Results

Gluten concentrations were below the lowest limit of detection (<3.0 ppm) for all tested lots of the API and excipients of Synthroid tablets. Aluminum content varied across tablet strengths (range 19–137 µg/tablet). Gluten levels of the API and excipients were found to be below the lowest level of detection and are considered gluten-free based on the US Food and Drug Administration (FDA) definition for food products. Across the various tablet strengths of Synthroid, the maximum aluminum levels were well below the FDA-determined minimal risk level for chronic oral aluminum exposure (1 mg/kg/day).

Conclusion

These data demonstrate that Synthroid tablets are not a source for dietary gluten and are a minimal source of aluminum.

Funding

AbbVie Inc.



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Correction of dropped head deformity through combined anterior and posterior osteotomies to restore horizontal gaze and improve sagittal alignment

Abstract

Objective

The aim of this study is to present our technique for a large focal correction of a partially flexible dropped head deformity through combined anterior and posterior osteotomies, as well as anterior soft tissue releases.

Methods

One patient with dropped head deformity underwent an anterior and posterior osteotomy with anterior soft tissue release.

Results

The patient recovered well, with postoperative radiographs demonstrating significant improvement in coronal and sagittal alignment. His C2–C7 sagittal vertical axis improved from 7.5 cm preoperatively to less than 4 cm postoperatively and his C2–C7 sagittal Cobb improved from 35° of kyphosis to 10° of lordosis.

Conclusion

In this report, we present our technique for a large focal correction of a partially flexible dropped head deformity through combined anterior and posterior osteotomies and anterior soft tissue releases. These more conservative osteotomies permitted gradual deformity correction and alleviated the need for pedicle subtraction osteotomy. We were able to restore horizontal gaze and improve sagittal malalignment. Although the technique we present here is one of many possible options for managing the deformity, we believe this combined approach is safe and effective and well tolerated by patients.



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Urgent need to strengthen and expand screening and other cancer control programs in the CARICOM Caribbean

Abstract

Purpose

With high mortality in breast, cervical, prostate, and colorectal cancers in Caribbean Community (CARICOM) countries, we examined cancer control initiatives including screening as well as the implementation of relevant international and regional mandates.

Methods

Secondary data were used to examine cancer control initiatives, which included the presence of national policies, programs, and screening services as well as the implementation of international and regional mandates. To identify the data, an on-line search was conducted using Google/Google Scholar.

Results

Data were available for 14 of the 15 full members of CARICOM. Although only six countries had distinct cancer control policies, strategies or action plans, all 14 had key elements of cancer control programs. Screening services were available in the 14 countries for cervical, in 12 countries for breast and in 11 for colorectal cancer. However, only four countries had screening policies. In addition, screening guidelines were available for cervical cancer in nine countries, in one country for breast and in none for colorectal cancer. Selected tobacco control policies were present in the 14 countries and immunization policies for human papillomavirus (HPV) in 13. Treatment services included chemotherapy in 10 countries and radiotherapy in six. Nine countries had palliative care services for patients with advanced disease. The countries were at different stages of implementation/compliance with international and regional mandates and frameworks.

Conclusions

There is an urgent need to develop and implement comprehensive and customized cancer control policies addressing screening programs, treatment and palliative care.



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