FDA approves tranexamic acid for menorrhagia
The U.S. FDA approved tranexamic acid tablets (Lysteda, Xanodyne Pharmaceuticals), the first non hormonal product cleared to treat menorrhagia.
Tranexamic acid was first approved by the FDA in 1986 as an injection, under the brand name Cyklokapron, and is used to reduce or prevent bleeding during and following tooth extraction in patients with hemophilia.
It is a synthetic lysine derivative that exerts its antifibrinolytic effect by reversibly blocking lysine binding sites on plasminogen and thus preventing fibrin degradation.
The most common adverse reactions reported in clinical trials included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue. There was a statistically significant reduction in menstrual blood loss in women who received Lysteda, compared with those taking placebo. Use of Lysteda while taking hormonal contraceptives may increase the risk of blood clots, stroke, or heart attack.
FDA approval of pazopanib for advanced renal cell cancer
Another drug, pazopanib (Votrient, GSK) has been added to the growing menu of options for treatment of advanced renal cell cancer, a disease for which only a few years ago we had few treatment choices. The approval was based on a phase III trial of 435 patients with advanced renal cell cancer who were randomized to either the drug or placebo. The response rate was 30% in the treated group, compared to 3% in the placebo group. The treated group did not show progression of their disease for a median duration of 11 months, compared to 2.8 months for the placebo group.
Pazopanib is an oral drug, and works by inhibiting angiogenesis, which is believed to play an essential role in the growth and spread of malignant tumors.
This is the sixth renal carcinoma drug approved since 2005. (The others are sorafenib (Nexavar), sunitinib (Sutent), temsirolimus (Torisel), everolimus (Afinitor) and bevacizumab (Avastin). All of these drugs are considered “targeted therapies” in contrast to conventional chemotherapy drugs. They each have a specific molecular target. None of these drugs have yet been studied in direct comparison with each other. Other approved drugs for advanced renal cell carcinoma include interleukin 2 and interferon. Trials of combinations of these agents, as well comparison studies of drugs head to head, are likely to be reported in the future.
New form of genetic thrombophilia reported
You can now add Factor IX Padua to your list of thrombophilic disorders. This gain of function genetic variant of Factor IX was identified in a patient with venous thromboembolism by physicians in--you guessed it--Padua, Italy. The subject patient was found to have nearly 800% of normal activity of factor IX. The genetic defect that he carried is a point mutation in the factor IX gene (G31134T transversion) that caused a substitution of leucine for arginine at position 338. Other family members were found to have varying degrees of abnormality, not nearly as great as the proband.
Since Factor IX activity elevation is in the differential of thrombophilic disorders, it seems possible that this specific abnormality could be added in the future to the laboratory evaluation of thrombophilia. Studies will have to be carried out to estimate the frequency of this abnormality in the general population. http://content.nejm.org/cgi/content/full/361/17/1671
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