Skip to Content

Weekly Drug News Round Up - July 25, 2012

FDA: Seizure Risk with Ampyra Use in Multiple Sclerosis

Ampyra should not be used in patients with a history of seizures or who have moderate to severe kidney impairment Read More...

Ampyra (dalfampridine) is an extended-release, oral potassium channel blocker used in multiple sclerosis (MS) patients to improve walking. The U.S. Food and Drug Administration (FDA) has issued a drug safety communication that seizures have occurred within days to weeks in patients without a seizure history starting Ampyra at the recommended dose. Seizures are a dose-related effect with Ampyra. Ampyra should not be used in patients with moderate to severe kidney impairment (creatinine clearance less than or equal to 50 mL/min) or a seizure history. Patients should only swallow Ampyra as a whole tablet and not take extra or double doses of Ampyra, even if a dose is missed.

Afinitor Approved for Advanced, Receptor Positive Breast Cancer

After lung cancer, breast cancer is the second leading cause of cancer-related death among women Read More...

The U.S. Food and Drug Administration has approved Afinitor (everolimus) to be used in combination with Aromasin (exemestane) for treatment of postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer. The combination is used in women with disease progression after receiving treatment with Femara (letrozole) or Arimidex (anastrozole). Clinical trials demonstrated that women who received Afinitor plus Aromasin had a 4.6 month improvement in the median time to disease progression or death compared to those receiving Aromasin plus placebo. Afinitor is the first drug from the class of mTOR inhibitors that is approved for treatment of postmenopausal women with advanced receptor-positive breast cancer.

Kyprolis Receives Accelerated Approval for Advanced Multiple Myeloma

Multiple myeloma is a form of blood cancer that grows in the bone marrow where blood cells are produced Read More...

In 2012, over 10,000 people are estimated to die from multiple myeloma. The U.S. Food and Drug Administration (FDA) has approved Kyprolis (carfilzomib) for treatment of patients with multiple myeloma whose disease has progressed despite treatment with at least two prior therapies, including Velcade (bortezomib) and an immunomodulatory therapy, such as Thalomid (thalidomide). Kyprolis clinical trials were designed to evaluate the percentage of patients who experienced complete or partial disappearance of tumor after treatment. The overall response rate was 23 percent with a median duration of 7.8 months. Kyprolis was approved under the FDA’s accelerated approval program that provides patients with earlier access to promising new drugs.

Tudorza Pressair Approved for Treatment of COPD

Clinical trials demonstrated efficacy in patients with COPD who smoked at least one pack a day for 10 years Read More...

Tudorza Pressair (aclidinium bromide) is an antimuscarinic agent approved for use in adults for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a serious lung disease often brought on by years of heavy cigarette smoking. Tudorza Pressair is available as a dry powder inhalation that helps to relax the muscles around the lung airways and improve airflow. Common side effects include headache, nasal inflammation, and cough. Expected serious side effects are typical of antimuscarinics and may include paradoxical bronchospasm, increased eye pressure, or urinary retention.

Whooping Cough Vaccine Booster Shots May Be Needed Every Ten Years

Over 18,000 cases of pertussis have already been reported - double the amount compared to this time last year Read More...

Whooping cough, also known as pertussis is a preventable disease but can be deadly in infants and young children. The pertussis vaccine is not given until after the first year of life and makes infants less than one year old especially susceptible to the disease. In addition, many adults have not had booster shots that are probably needed every ten years. A report published in the Morbidity and Mortality Weekly Report notes that whooping cough has already caused the death of nine infants in the U.S. this year. One suggestion to stopping the spread of pertussis is a revaccination campaign to administer the booster shot, especially to pregnant women and those who have contact with infants.