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Drospirenone Carries Higher Risk For Venous Thromboembolism – FDA Adds Warning Lable

April 12, 2012 By Leave a Comment

Synthetic progestin drospirenone containing oral contraceptives may carry a higher risk for venous thromboembolism than pills with other types of progestins.

This announcement was made today by the US Food and Drug Administration announced today.

FDA is adding information about the studies to the labels of drospirenone containing birth control pills. The labels would report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone containing products.

The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk. [Read more...]

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Brentuximab

January 16, 2012 By Leave a Comment

Brentuximab vedotin is an antibody-drug conjugate approved to treat anaplastic large cell lymphoma (ALCL) and Hodgkin lymphoma. The drug was approved in August by FDA.

Antibody drug conjugate consists of an antibody linked to a payload drug. This kind of mechanism helps to deliver the drug to targeted cells like cancer cells.

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US Food and Drug Administration Issues Warning About Lymphoma Drug Brentximab

January 14, 2012 By Leave a Comment

The US Food and Drug Administration (FDA) has issued a warning about the lymphoma drug brentuximab (Adcetris, Seattle Genetics).

This warning comes after two new cases of progressive multifocal leukoencephalopathy a rare but serious brain infection.

A new Boxed Warning highlighting this risk has been added to the drug label.

In addition, a new Contraindication warning was added against use of Adcetris with the cancer drug bleomycin due to increased risk of lung toxicity.

Brentuximab was approved by the FDA in August 2011 for the treatment of Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma.

Healthcare professionals should suspend brentuximab dosing if PML is suspected, and discontinue the drug therapy if a diagnosis of PML is confirmed, according to the FDA.

Source: FDA site

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Natalizumab

December 15, 2011 By Leave a Comment

Natalizumab is a humanized monoclonal antibody against the cellular adhesion molecule α4-integrin used in the treatment of multiple sclerosis and Crohn’s disease.

Natalizumab is administered by intravenous infusion every 28 days. The drug is believed to work by reducing the ability of inflammatory immune cells to attach to and pass through the cell layers lining the intestines and blood-brain barrier.

Natalizumab has been found to be effective in treating the symptoms in both Crohn’s disease and multiple sclerosis. In multiple sclerosis, it also is effective in preventing relapse, vision loss, cognitive decline and significantly improving quality of life in people. [Read more...]

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FDA Approves Bupivacaine Extended-Release Liposome Injection (Exparel) for Postoperative Pain

December 11, 2011 By Leave a Comment

New long-acting nonopioid anesthetic/analgesic for postsurgical pain by US Food and Drug Administration. The drug is bupivacaine extended-release liposome injection (Exparel, Pacira Pharmaceuticals).

Exparel consists of bupivacaine encapsulated in the multivesicular liposome DepoFoam [Pacira Pharmaceutical's extended drug-delivery technology].

The new product is designed to extend the duration of analgesia provided by bupivacaine. Exparel provides continuous and extended postsurgical analgesia for up to 72 hours compared with bupivacaine’s analgesic time of 7 hours.

The new drug is expected to reduce the dependence on opioid use in the postoperative setting.

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New Cochrane Review Says Natalizumab Reduces Relapses and Disabilty In Multiple Sclerosis

October 14, 2011 By Leave a Comment

New-generation anti-inflammatory drug natalizumab  in multiple sclerosis, published online October 5, show the drug reduces relapses and disability at 2 years, a Cochrane review findings suggest.

This new review is based on 3 key natalizumab trials involving 2223 patients.

Natalizumab is a monoclonal antibody that inhibits leukocyte migration across the blood–brain barrier. It is said to reduce inflammation in the central nervous system and has been approved worldwide for the treatment of relapsing-remitting multiple sclerosis. [Read more...]

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NSAIDs in Early Pregnancy Linked to Risk for Miscarriage

September 30, 2011 By Leave a Comment

A case control study published online September 6 in the Canadian Medical Association Journal says that nonaspirin nonsteroidal anti-inflammatory drugs use in early pregnancy is linked to twice the risk for miscarriage

The authors conducted the study with an aim to quantify the association between having a spontaneous abortion and types and dosages of nonaspirin NSAIDs in a cohort of pregnant women.”

The study consisted of 4705 women who were identified from the Quebec Pregnancy Registry and who had a spontaneous abortion. [Read more...]

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Systemic Review Confirms Cardiovascular Risks With Non Steroidal Antiinflammatory Drugs

September 29, 2011 By Leave a Comment

A large systematic review confirms that rofecoxib is associated with a significantly increased risk of cardiovascular events and also suggests thatt diclofenac also poses an equivalent risk to patients.

Ibuprofen and naproxen are the least likely to increase the risk of MI and coronary heart disease death.

The study has been published by Patricia McGettigan  and David Henry on  September 27, 2011 in the open-access journal PLoS Medicine. [Read more...]

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Eplerenone

December 27, 2010 By Leave a Comment

Eplerenone  is an aldosterone antagonist, spironolactone.

Indications

Eplerenone is  indicated for the reduction of risk of cardiovascular death in patients with heart failure and left ventricular dysfunction within 3–14 days of an acute myocardial infarction, in combination with standard therapies and as treatment against hypertension. [Read more...]

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Taking Levothyroxine At Bed Time Gives Better Results Than In Morning

December 20, 2010 By Leave a Comment

In a randomized prospective crossover study published recently in Archives of Internal Medicine, it has been found that taking levothyroxine on an empty stomach at bedtime, instead of in the morning before breakfast results in significant improvements in thyroid hormone levels.

The study that included 90 patients who completed the study.

The author suggested that night time tablet is more convenient also

However, bedtime dosing, relative to morning dosing, had no significant impact on measures of quality of life (including fatigue, anxiety and depression), creatinine or lipid levels, blood pressure, body mass index or heart rate.

Arch Intern Med. 2010;170(22):1996-2003. doi:10.1001/archinternmed.2010.436
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