New & Approved: Yasmin Twinrix Avelox

OB/GYN News, June 15, 2001 by Elizabeth Mechcatie

Yasmin

(drospirenone 3 mg and ethinyl estradiol 0.030 mg, Berlex)

A low-dose, monophasic OC. The first OC to contain drospirenone, an analogue of spironolactone, as its progestin component.

* Recommended Dosage: One tablet daily for 21 days, followed by 7 days of one inert tablet daily.

* Special Considerations: Drospirenone's antimineralcorticoid properties make it contraindicated in women with renal or adrenal insufficiency or hepatic dysfunction. Serum potassium should be checked during the first cycle in women on daily NSAIDs, ACE-inhibitors, or other drugs that can increase serum potassium.

* Comment: Yasmin is effective and appears to be safe for "most women," said Dr. Robert Hatcher, professor of gynecology and obstetrics at Emory University, Atlanta.

Regarding the newness of drospirenone, which is unlike any other progestin used in OCs, Dr. Hatcher, who was not involved in Yasmin trials, is concerned that some physicians won't pay close attention to the recommended precautions regarding medications a woman may take before prescribing her Yasmin. This issue "will complicate the provision of OCs, since it is no longer correct to assume that if a woman can use estrogen, she is a candidate for any available combination OC."

Claims that drosperinone helps counteract fluid retention "are going to need careful substantiation," he added.

Twinrix

(hepatitis A inactivated and hepatitis B recombinant vaccine, GlaxoSmithKline)

A vaccine for preventing both hepatitis A and B in adults, the first combination hepatitis vaccine.

* Recommended Dosage: 3 doses, at 0, 1, and 6 months.

* Special Considerations: In trials, injection site soreness, headache, and fatigue were among the most common side effects, which were mild, lasted less than 48 hours, and were similar to those seen with the separate vaccines.

* Comment: In 11 clinical trials with 1,551 subjects vaccinated on a 0-, 1-, and 6-month schedule, 99.9% responded to the hepatitis A component, and 98.5% responded to the hepatitis B component. "This is a very safe and exceedingly effective vaccine," comparable with the current hepatitis A and B vaccines, said Dr. William Schaffner, chairman of the department of preventive medicine, Vanderbilt University, Nashville, Tenn.

When counseling patients who plan to travel--the main target group for hepatitis A vaccine in this country--physicians may want to discuss the benefits of also being protected against hepatitis B in case of iatrogenic exposure abroad. Adolescent studies of Twinrix are planned. Dr. Schaffner said that he has no financial ties to the manufacturer,

Avelox

(moxifloxacin, Bayer)

A fluoroquinolone for uncomplicated skin and skin structure infections due to Staphylococcus aureus and Streptococcus pyogenes in adults. Previously approved for respiratory tract infections.

* Recommended Dosage: 400 mg once a day for 7 days.

* Special Considerations: Avelox can cause QT prolongation, but no adverse cardiovascular effects were seen in premarketing trials or in a postmarketing study of more than 18,000 patients with respiratory infections, according to Bayer. Still, the label warns against using Avelox in patients with known prolongation of the QT interval, uncorrected hypokalemia, or use of class IA or class III antiarrhythmics.

* Comment: In a study of 351 patients, uncomplicated skin and skin structure infections resolved in 90% of those treated with Avelox and in 91% of those treated with 500 mg of cephalexin three times daily Avelox is effective against gram-negative bacteria and erythromycin-resistant group A [beta]-hemolytic streptococci, said lead investigator Dr. Lawrence Parish, clinical professor of dermatology and cutaneous biology at Jefferson Medical College, Philadelphia.

"It will be useful ... when several organisms are suspected or for infections in the lower half of the body where gramnegative organisms might be considered," such as decubitus or diabetic foot ulcers, said Dr. Parish, who reported having no financial ties to Bayer.