Health care updates, March 19: Safety and approvals

SAFETY UPDATES

National Poison Week
This week is National Poison Week in the US. This annual health observance has been in place since 1962. We will deal with this topic in detail next week. In the meantime, here are some resources for you to check out:

• Poison Prevention by the CDC
• Medications disposal

FDA Issues Final Rule Restricting Access and Marketing of Cigarettes and Smokeless Tobacco Products to Youth
The final regulations on access of minors to tobacco products is out. The new regulations include, among others:

• Prohibition of selling cigarettes or smokeless tobacco to those younger than 18
• Restriction of distribution, and promotion of these products to make them less accessible and less attractive to the young
• Prohibition of giving out free samples of cigarettes
• Prohibition of tobacco brand name sponsorship of any athletic, musical or other social or cultural events.

According to HHS Secretary Kathleen Sebelius:

“This ruling is a critical piece of a coordinated effort to save lives, lower costs, and reduce suffering from heart disease, cancer and other tobacco-related illness. Today, we’re addressing a larger public health effort to prevent our children from becoming the next generation of Americans to die early from tobacco-related disease. This is a great step toward a healthier America.”

Safety Review of Avandia (Rosiglitazone)
The US FDA is conducting a review of safety data on the diabetic agent rosiglitazone which is expected to be finished in July 2010. In the meantime, it gives some advice for people take the drug, which can be found here.

Safety Review of Osteoporosis Medications
Oral bisphosphonates are indicated for the treatment and prevention of osteoporosis in postmenopausal women. The FDA data on these drugs based on questions whether they increase the risk of fractures in the bone below the hip bone. The FDA review found no elevated risk for this type of fracture associated with oral bisphosphonate use.

RECENT APPROVALS

FDA Approves First Totally Implanted Hearing System
The US FDA has just approved an implanted hearing system for the treatment of moderate to severe sensorineural hearing loss. Esteem is the first totally implanted hearing system, and consists of three implantable components: a sound processor, sensor, and driver.
Sensorineural hearing loss is caused by genetic or environmental factors (e.g. noise, injury, infection) that results in reductions in sound perceptions and eventually permanent hearing loss.

FDA Approves Drug  to Treat Condition That Causes Elevated Ammonia Levels
Another approval this week is for Carbaglu (carglumic acid) Tablets, indicated for the treatment of hyperammonemia in N-acetylglutamate synthase or NAGS deficiency. NAGS deficiency is a rare genetic disorder usually occurring in newborn babies. The deficiency results in high ammonia blood levels that can be fatal. NAGS deficiency can be detected by genetic testing.