Category Archives: Endocrine

Propylthiouracil (PTU) side effects: FDA warned about risk of hepatotoxicity

The FDA warned prescribers about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil (PTU). FDA’s warning highlights: There is an increased risk of liver injury with propylthiouracil (PTU) when compared to methimazole. Monitor for symptoms and signs of liver injury when propylthiouracil is chosen as anti-thyroid therapy. This…

FDA: potential risk of HIV and hepatitis transmission when insulin pens and cartridges are shared

An excerpt of FDA’s press release issued  19th March 2009: The U.S. Food and Drug Administration today issued an alert to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients due to the potential risk of transmitting blood-borne pathogens such as HIV…

More evidence that bisphosphonates do not increase the risk of atrial fibrillation (AF) or flutter

Bisphosphonates don’t increase the risk of atrial fibrillation, according to the study Oral Bisphosphonates and Risk of Atrial Fibrillation and Flutter in Women: A Self-Controlled Case-Series Safety, published in PLoS One on March 2009. The authors used a self-control case series analysis to study nearly 400,000 women from the UK General Practice Research Database. They…

Experts comment the JUPITER trial in the latest NEJM issue

Experts around the globe comment the JUPITER trial in the correspondence section of the March 5, 2009 issue of the  NEJM. I collect here some of the most relevant and interesting correspondence to the editor. “JUPITER is notable for the unacknowledged exclusion of a population that may be at increased risk for dose-related adverse effects…

Animation of thiazolidinediones (TZDs) and fibrates mechanism of action. PPAR activation movie

This excellent animation from the Hybrid team shows in detail the process of activation of the PPAR receptor, its interaction with the RXR and the ligand. This animation is an excellent oportunity to review the drugs that act as ligands of the PPAR receptor and its subtypes (Alpha and Gamma). Novel agents that target PPAR…

FDA updated information about a safety review of Ezetimibe/Simvastatin (Vytorin), Ezetimibe (Zetia), and Simvastatin (Zocor)

FDA updated yesterday ( January 8, 2009) information related to their review of the ENHANCE trial: On January 25, 2008, FDA announced that it would be reviewing data from the ENHANCE trial (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia). (http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm). Preliminary results from this…Continue Reading

Ibandronic acid (Bondronat) for the treatment of hypercalcaemia and bony metastases. Australian Prescriber review

From Australian Prescriber: Ibandronic acid Bondronat (Hospira) vials containing 6 mg/6 mL Approved indications: hypercalcaemia, bony metastases of breast cancer Australian Medicines Handbook section 10.3.1 Bisphosphonates can reduce the hypercalcaemia of malignant disease by inhibiting the resorption of bone. Clodronate, pamidronate and zoledronic acid are already available for this indication. They are nowContinue Reading

Paricalcitol (Zemplar): a vitamin D analogue for the treatment of secondary hyperparathyroidism. Australian Prescriber review

From Australian Prescriber: Paricalcitol Zemplar (Abbott) 1 microgram, 2 microgram and 4 microgram capsules 5 microgram/mL in 1 mL and 2 mL ampoules Approved indication: secondary hyperparathyroidism Australian Medicines Handbook section 10.3.2 In chronic renal failure there is reduced production of calcitriol, the active form of vitamin D. This affects calcium homeostasis and leads to…Continue Reading

AHRQ Comparative Effectiveness Review. Premixed insulin analogues for adults with type 2 diabetes.

From the AHRQ newsletter, December 18, 2008, Issue # 2. Comparative Effectiveness Review. Premixed Insulin Analogues for Adults With Type 2 Diabetes Premixed insulin preparations are an alternative that may permit a smaller number of daily insulin injections. Although oral diabetes medicines are used as first-line treatments in patients with type 2 diabetes, insulin is…Continue Reading

CHMP positive opinion for lasofoxifene (Fablyn), a new SERM

Press release about the positive opinion of the CHMP for Fablyn (lasofoxifene): COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE  SUMMARY OF POSITIVE OPINION for FABLYN International Nonproprietary Name (INN): lasofoxifene On 18 December 2008  the Committee for Medicinal Products  for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the…Continue Reading

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