FDA approves several new drugs, including one for high cholesterol
Perhaps keeping an eye on the upcoming dead week between Christmas and New Year’s, the US Food and Drug Administration issued a string of announcements at the end of last week approving a list of new drugs; here’s a rundown.
1. New drug to treat high cholesterol. Juxtapid was approved to treat a rare genetic form of high cholesterol; the condition, which occurs in about 3,000 Americans causes super-high cholesterol levels and heart attacks at an early age. The drug injections will cost $200,000 to $300,000 annually, according to the Wall Street Journal, and will require safety precautions because of its liver risks.
2. Tamiflu approved for babies. The anti-viral drug Tamiflu (oseltamivir) can now be given to infants as young as two weeks old who have shown symptoms of flu -- fever, lethargy, coughing, and runny nose -- for no longer than two days. Previously, Tamiflu had only been approved for use in children age one year and older. Doctors will need to use a different dispenser and carefully calculate the dose needed for treatment based on a baby’s weight, according to the FDA. While the drug appears to be safe in babies based on the manufacturer clinical trial data, just 135 patients under age 1 were enrolled in the two safety studies; vomiting and diarrhea were the most common side effects reported with the drug.
3. Varizig approved for reducing chicken pox symptoms. While most people are immune to the varicella virus (aka chicken pox) after getting infected during childhood or receiving the vaccine, this new drug can help reduce symptoms in those who do get the potentially life-threatening virus. It needs to be given within four days of exposure, according to the FDA.
4. New drug for short bowel syndrome. The FDA approved a daily injection called Gattex (teduglutide) to treat adults with short bowel syndrome -- which results from the partial surgical removal of the small or large intestine due to cancer, colitis or other conditions -- who receive intravenous nutrition. The injection can help the intestines retain nutrients to prevent nutritional deficiencies.Deborah Kotz can be reached at email@example.com. Follow her on Twitter @debkotz2.