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User: LawsuitGuru

Increased Risk of Bone Fractures in Women Treated with Diabe Two manufacturers of thiazolidinedione drugs, which are used to treat type 2 diabetes, have notified healthcare professionals that women taking these drugs have an increased risk of bone fractures. The first company, GlaxoSmithKline, makes Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate and metformin hydrochloride), and Avandaryl (rosiglitazone maleate and glimepiride), which all contain rosiglitazone. In a recent clinical trial, women who took drugs containing rosiglitazone experienced a higher incidence of fractures than those treated with metformin or glyburide therapy. The majority of these fractures were in the upper arm, hand and foot. The second company, Takeda, makes Actos (pioglitazone), ACTOplus met (pioglitazone and metformin hydrochloride), and Duetact (pioglitazone and glimepiride) which all contain pioglitazone. An analysis of the company's clinical trial database showed that drugs that contain pioglitazone may also increase fracture risk in women. The clinical significance of these findings is uncertain at present. Still, both companies recommend that the possibility of fracture be taken into account when rosiglitazone or pioglitazone are considered for treating female patients with type 2 diabetes. Additional Information: FDA MedWatch Safety Alert. Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate and metformin hydrochloride), Avandaryl (rosiglitazone maleate and glimepiride). February 21, 2007. http://www.fda.gov/medwatch/safety/2007/safety07.htm#rosiglitazone FDA MedWatch Safety Alert. Actos (pioglitazone) Tablets http://www.fda.gov/medwatch/safety/2007/safety07.htm#Actos Tags: Bone Fracture Women Diabetes Drugs Avandia Avandamet Avandaryl Rosiglitazone FDA Drug Reaction Actos ACTOplus

User: LawsuitGuru

Ongoing Safety Analysis for Avandia (Aug. 2007) UPDATE: The FDA's Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management Advisory Committees met on July 30, 2007 to discuss the cardiovascular ischemic/thrombosis risks of thiazolidinedione drugs, with focus on rosiglitazone, as presented by FDA and GlaxoSmithKline. For more information about the meeting, see "Additional Information" link below. FDA is continuing to review safety data on the drug rosiglitazone maleate. Some of these data suggest that rosiglitazone may increase a patient's risk of heart attack and heart-related deaths compared with other drugs that also treat type 2 diabetes. Rosiglitazone is sold as Avandia, Avandamet and Avandaryl. A pooled analysis of 42 clinical studies provided by the manufacturer suggested that patients receiving short-term treatment with rosiglitazone may have a 30-40 percent greater risk of heart attack and other cardiovascular events compared with placebo or other anti-diabetic therapy. However, other published and unpublished data from long-term clinical trials provide contradictory evidence about the risk. It is uncertain at this point whether taking rosiglitazone does increase the risk of these adverse events and if so, by how much. It is also not clear whether pioglitazone, the other approved product in the same drug class, may pose the same risk. Also, switching diabetic patients from one drug to another carries its own inherent risk. Healthcare professionals should consider these factors when deciding about treatment for their diabetic patients. FDA's review of all the available data is continuing. Additional Information: FDA MedWatch Safety Alert. Avandia (rosiglitazone). May 21, 2007. http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia FDA/Center for Drug Evaluation and Research. Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, July 30, 2007. Draft Agenda. http://www.fda.gov/ohrms/dockets/ac/07/agenda/2007-4308a-agenda-draft.pdf FDA/Center for Drug Evaluation and Research. Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, July 30, 2007. Briefing Information. http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4308b1-00-index.htm FDA MedWatch Safety Alert. Avandia (rosiglitazone maleate) Tablets, Actos (pioglitazone hydrochloride) Tablets, Avandaryl (rosiglitazone maleate and glimepiride) Tablets... August 14, 2007. http://www.fda.gov/medwatch/safety/2007/safety07.htm#rosi_pio Tags: Avandia FDA Patient Safety Rosiglitazone Heart Attack Drug Reaction Diabetes

User: USFoodandDrugAdmin

Stronger Warnings on Avandia and Certain Diabetes Drugs The manufacturers of thiazolidinedione drugs have strengthened warnings about the risks of heart failure with these medications, which are use to treat type 2 diabetes. They are sold as Avandia (rosiglitazone maleate), Avandaryl (rosiglitazone maleate and glimepiride), and Avandamet (rosiglitazone maleate and metformin hydrochloride), which all contain rosiglitazone, and Actos (pioglitazone hydrochloride), Duetact (pioglitazone hydrochloride and glimepride) and Actoplus met, which all contain pioglitazone. The drug labels already had information about heart failure risk, but now there is a new boxed warning that re-emphasizes that these drugs may cause or worsen heart failure in certain patients, and stresses the importance of carefully monitoring patients for signs of heart failure. The labeling recommends that after starting thiazolidinedione therapy or increasing the dose, patients should be observed carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema. If any of these signs and symptoms develop and heart failure is confirmed, practitioners should start appropriate management of the heart failure and consider stopping or reducing the dose of the drug. The boxed warning also notes that these drugs are not recommended for patients with symptomatic heart failure, and are specifically contraindicated in patients with NYHA Class III or IV heart failure. FDA Patient Safety News: October 2007 For more information, please see our website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=68#2 Tags: Avandia Actos pioglitazone rosiglitazone diabetes heart failure

User: mckickflip

Superawesome squad (pilot) this is the pilot episode of Superawesome squad, which will be the best new show ever made. this episode contains clips from Shpongle's "Are you Shpongled?". Tags: super awesome superawesome squad linux penguin happy feet avandaryl blue stapler trippy messed up

User: mckickflip

Superawesome squad (ep 1) in this episode of the Superawesome squad the magical glue stick is defeated and then rebuilt featuring ween on the cd player Tags: awesome squad linux penguin happy feet avandaryl blue stapler trippy messed up

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