Trumm Drug

August 2009 Drug News

All States Now Permit Pharmacists to Immunize

Maine has become the 50th state to allow pharmacists to administer immunizations. The law requires pharmacists to undergo specialized training, and limits immunizations to individuals at least 9 years old.

One-dose emergency contraceptive approved by FDA

Teva announced today that Plan B One-Step emergency contraception (levonorgestrel tablet, 1.5 mg) has been approved by FDA. The agency has made Plan B One Step available OTC to women 17 and older and by prescription to women younger than 17; this is an expansion from Plan B, which is available OTC to women 18 and older and by prescription to women younger than 18. The one-tablet product can help prevent unintended pregnancy after unprotected sex or contraceptive failure.
When taken as directed-within 72 hours of unprotected sex or contraceptive failure-Plan B One-Step is highly effective in reducing the chance of pregnancy. It can prevent pregnancy in seven out of eight women who use it, according to a Teva news release. “Plan B One-Step is an exciting milestone in women’s reproductive health, and I applaud Teva for continuing to develop products that empower women,” Kelli Conlin, President of the National Institute for Reproductive Health, said in the news release.
Plan B One-Step should be taken as soon as possible after unprotected sex; the sooner it is taken, the more effective it will be. It will not work if a woman is already pregnant and it will not terminate an existing pregnancy. It does not protect against HIV or other sexually transmitted diseases. Side effects can include changes in menstrual cycle, nausea, lower abdominal pain, fatigue, headache, dizziness, and breast tenderness.
Pharmacies that stock Plan B OTC must keep the product behind the counter and confirm a requesting patient’s age by requesting to see government-issued identification. The product will be available in U.S. pharmacies in August.

FDA Requires Warning for Chantix, Zyban

The Food and Drug Administration will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency’s strongest safety warning over side effects including depression and suicidal thoughts.

FDA Questions Safety of Zicam

FDA advised consumers not to use Matrixx Initiatives’ intranasal Zicam products after receiving more than 130 adverse event reports that the zinc-containing OTC products cause anosmia, loss of the sense of smell.
The agency issued a warning letter to Matrixx to stop marketing the homeopathic products. The Scottsdale Ariz.-based firm removed existing inventory from the marketplace. The products, major growth drivers for the company, include Cold Remedy Nasal Gel and Cold Remedy Swabs. FDA also questions the safety of a discontinued product, children’s size Cold Remedy Swabs.

---