FDA Approvals and podcasts: healthcare updates, January 29

January 29, 2010 by  
Filed under HEALTHCARE


The US FDA has been very busy and has announced several major approvals this month.

FDA Approves New Treatment for Type 2 Diabetes
The US FDA has approved Victoza (liraglutide), a treated for type 2 diabetes to be administered an a once-daily injection. Victoza can help keeping blood sugar levels under control and should be used concomitantly with proper diet, physical execise, and other anti-diabetes medications. It is not recommended as initial therapy in patients who have not achieved adequate diabetes control on diet and exercise alone. It is manufactured by Novo Nordisk of Bagsvaerd, Denmark.

FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
Another drug to get the go signal from the FDA this month is Ampyra (dalfampridine). Ampyra is indicated for patients with multiple sclerosis to improve walking and comes in extended release tablets. It is contraindicated in patients with moderate to severe kidney disease. Ampyra will be manufactured under licenses from Elan of Dublin, Ireland, and distributed by Acorda Therapeutics Inc. of Hawthorne, N.Y.

FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain
The FDA has also approved morphine sulfate oral solution indicated for pain relief in moderate to severe, acute and chronic pain in opioid-tolerant patients. It is available in as oral solution in concentrations of 100 milligrams per 5 mL or 20 milligrams per 1 mL. Because of the nature of the drug, the manufacturer was required by the FDA to develop “a safety program prior to approval to address the known risks of morphine misuse, abuse and overdose.”

In addition, a couple of medical devices and implants have also been approved in January and are reviewed in Heart(y) news, January 29.


AHRQ Radio Series – Treating COPD
In this audio cast, the Agency for Healthcare Research and Quality (AHRQ) presents the latest data on chronic obstructive pulmonary disease (COPD). Dr. William Lawrence summarizes the two reports on COPD management:

“The investigators evaluated the medicine tiotropium, also known as Spiriva. They found that people who took this medicine with inhaled corticosteroids and long-acting beta-agonists had a lower rate of COPD-related death. In a different report, they evaluated the drug theophylline in combination with six different types of treatments. They found patients receiving theophylline had a slightly increased risk of death. More research is needed to understand whether theophylline actually contributed to these outcomes.”

Online health chats at Cleveland Clinic
Several health chats are scheduled for February.

Chats on topics are listed in Heart(y) news, January 29.

Photo credit: stock.xchng

Good news for the New Year: new drugs against breast cancer

December 31, 2008 by  
Filed under CANCER

Some news of hope for the new year.

Medical researchers are continuously working on the quest for a drug that can cure breast cancer. The last significant breakthrough was three decades ago when tamoxifen was found to reduce the risk of recurrence of breast cancer. At the CTRC-AACR San Antonio Breast Cancer Symposium in Texas this year, several drugs that show promise for curing this deadly disease have been presented.

Among these drugs, zoledronic acid (Zometa) was found to be the most promising one. Zoledronic acid is a drug used for treating osteoporosis. Recent studies, however, showed that this drug may potentially have direct anti-tumor properties and can also shrink breast tumors in patients who are undergoing chemotherapy. Zoledronic acid is already an approved drug for treating breast cancer that has spread to the bone. Aside from osteoporosis, however, they discovered that it can also lower the risk of breast cancer recurrence in pre-menopausal women with early estrogen- or progesterone-positive tumors. This was based on the study involving more than 200 women with breast cancer. Those patients who were treated with zoledronic acid in addition to chemotherapy have better results compared to those who were treated with chemotherapy alone. The “chemotherapy-alone” group had an average tumor size of 42.4 millimeters. This is significantly bigger compared to those patients with the zoledronic acid – chemotherapy combination where the average tumor size was only 28.2 millimeters.

Zoledronic acid is currently being evaluated against breast cancer in the clinical trial AZURE (Adjuvant Zoledronic Acid to Reduce Recurrence).

“This data suggests that zoledronic acid is doing something more than protecting bone,” said study senior author Dr. Robert Coleman, a professor of medical oncology at the University of Sheffield in England. “It’s not practice-changing. It’s hypothesis-generating, which will lead to the design of new trials to look at this in detail. But this is the first patient-related evidence.”

The other promising drugs presented in the symposium include the following:

  • Aromatase inhibitor exemestane (Aromasin) reduced cancer by 15% and reduced the risk of distant metastasis by 19% in postmenopausal women with breast cancer.
  • Herceptin (trastuzumab) which is a drug used to treat HER2-positive breast cancer plus chemotherapy before surgery resulted in 70% of women surviving for 3 years without cancer recurrence.
  • Lapatinib (Tykerb) which is another HER2 inhibitor if combined with another aromatase inhibitor can extend progression-free survival by 5 months on patients with HER2-positive metastatic breast cancer.
  • Aromatase inhibitors show promise as potential replacement of tamoxifen as standard treatment to prevent recurrence of breast cancer in women who have already undergone conventional therapy.


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NOTE: The contents in this blog are for informational purposes only, and should not be construed as medical advice, diagnosis, treatment or a substitute for professional care. Always seek the advice of your physician or other qualified health professional before making changes to any existing treatment or program. Some of the information presented in this blog may already be out of date.