RECENT FDA APPROVALS
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.
AUDIO CASTS, ONLINE HEALTH CHATS
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.
- February 8: Keeping Your New Year’s Weight Loss Resolution with Dr. Maxine Smith
- February 10: Understanding Spinal Stenosis with Dr. Steinmetz
- February 17: Alternative Treatment Options for Managing Your Health with Dr. Tanya Edwards
- February 23: Diagnosis & Treatment of Chronic Pain Disorders with Dr. Jahangir Maleki
Chats on topics are listed in Heart(y) news, January 29.
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