As these things go, 2004 was quite a big year when it came to medical drugs, particularly those for women.
Some of the news was bad (the Vioxx recall and the influenza vaccine shortage), some disappointing (Plan B — the so-called morning-after pill — was not approved for over-the-counter purchase) and some good (a whole host of promising new products that received Food and Drug Administration approval).
Dr. Judith Reichman, the “Today” show’s medical contributor on women’s health, provides a perspective on the year that was — and a look at what's coming down the drug-industry pipeline.
Q: What were the “outstanding” medications that received FDA approval last year?
Estrogen for menopausal symptomsNew modes of estrogen therapy, given through the skin, were recently FDA-approved. In contrast to oral or pill ingestion, estrogen absorbed through the skin may be less likely to increase the risk of blood clots or cause changes in the vascular system that are associated with coronary heart disease. Up to now skin (transdermal) estrogen has been prescribed with estradiol patches such as Climara and Vivelle. The new products are formulated in a gel or emulsion that is rubbed into the skin.
Estrogel: The estrogen in this medication is mixed into an alcohol-based absorptive gel. One measure of the gel is rubbed into the inner arm. The skin then acts as a reservoir, slowly releasing the absorbed estrogen into the body so that blood levels rise and remain steady.
Another product, Estrasorb, works on the same principle, though here the estradiol is in a soy-based emulsion that comes in a foil pouch. Two pouches supply a daily dose, which is rubbed into the thigh and calf of each leg for three minutes until thoroughly absorbed.
Q: Do these products contain progestin to protect the uterine lining?
A: No. So if a woman has not had a hysterectomy and uses the gel or cream, she should take some form of progestin to prevent abnormal endometrial buildup that could lead to uterine cancer.
Estrogen for osteoporosis preventionA very low-dose estrogen patch which doesn’t require regular use of progestin has also been FDA-approved this year. This product, called Menostar, helps prevent osteoporosis. Remember that loss of estrogen during menopause may cause a fairly rapid loss of bone mass, especially in the first few years. It turns out that even micro doses of estrogen can help prevent this. Menostar delivers a very low dose of plant-derived estrogen (estradiol) in a once-a-week patch. The amount that’s released through the skin is about one-third that provided by the most common doses of estrogen replacement “traditionally” used for menopausal symptoms. Studies have shown that after two years, Menostar not only stopped bone loss, but caused a 2 percent to 3 percent increase in spinal bone density, and a nearly 1 percent increase in hipbone density in 60- to 80-year-old women.
Although most women don’t need progestin with this product, the company recommends that to be safe, a 14-day course of progestin be given every six to 12 months, and if necessary, that the uterine lining be evaluated once a year (this can be done by ultrasound or biopsy).
Q: Going beyond hormonal products, what other medications received the FDA’s blessing in the past year?
Treating overactive bladder: SancturaThis is an anti-spasmodic medication that prevents certain nerve receptors from becoming stimulated, while it also relaxes the smooth muscle in the bladder so that unwanted contractions — and the accompanying urge to go to the bathroom — are diminished. The final result is that there is a decrease in symptoms of urgency (up to 84 percent after 12 weeks) and frequency (46 percent) and less involuntary loss of urine. In other words, fewer accidents on the way to the bathroom. As with most medications, there can be some side-effects, which include a dry mouth, drowsiness, dizziness and constipation.
Vaginitis reliefOne of the leading causes of vaginal burning and malodorous discharge is trichomonas vaginalis. This type of vaginal infection is caused by a protozoa (a one-celled organism) that is sexually transmitted. There is a new anti-protozoal agent called Tindamax, which, with just a one-time dose of two grams, cures this type of infection. Tindamax has also been approved to treat intestinal, amoebic and giardia infections as well as liver abscesses due to amoebic infection. Alcohol should be avoided for at least three days after therapy since it interacts with Tindamax and can cause abdominal cramps, nausea and vomiting.
For depression and pain: Cymbalta (Duloxetine)This is a new SSRI (Selective Serotonin Reuptake Inhibitor) that has received FDA approval for the treatment of major depressive disorder as well as pain in the extremities associated with nerve damage from diabetes (diabetic peripheral neuropathy). This drug increases levels of two nerve chemicals related to depression, serotonin and norepinephrine. These chemicals also help “turn down” the volume of pain and hence diminish the pain felt from nerve damage caused by diabetes.
Like other SSRIs, Cymbalta can initially cause nausea, dry mouth, constipation, decreased appetite, sleepiness and, on rare occasion, increase in blood pressure (which should be checked periodically).
Q: What are the up-and-coming therapies in 2005?
A new birth-control pillA new birth-control pill called Yas, which contains a very low dose of estrogen (20 micrograms of ethinyl estradiol) and a new type of progestin (drospirienone) are in line for final FDA approval. It follows its “older sister,” Yasmin, that is formulated with a slightly higher dose of estrogen. This type of birth-control pill is unique in that the progestin component has a mild diuretic effect and blocks the effects of testosterone in the skin, therefore decreasing bloating, weight gain and acne. The manufacturer is also seeking an indication for Yas to treat severe PMS (PMDD).
Hormone therapyAngeliq also contains this new type of progestin, together with estradiol, and has been submitted for approval for the treatment of menopausal symptoms. Because it contains this progestin together with estrogen it will be a new “one pill only” form of hormone replacement therapy.
Weight loss, smoking cessationA drug called Acomplia (Rimonabant) may be submitted for FDA approval this year. Studies have shown that it can improve risk factors related to diabetes and can help with smoking cessation and weight loss. It works by blocking certain receptors in the brain that help regulate food intake and energy expenditure. These receptors are also found on fat cells and are involved in the metabolism of fat tissue. It’s felt that these receptors may be overactive in overweight and obese individuals and hence send out signals to eat more. If they’re blocked with this drug, appetite may diminish, as well as the desire to smoke, and there may also be an improvement in caloric utilization, cholesterol levels and diabetes control. Sounds promising, but further studies may be required to see if these effects are long-lasting and whether there are significant side effects (such as depression).
ArthritisNew drugs that work to diminish inflammation — and are not in the category associated with problematic drugs such as Vioxx — may be submitted for FDA approval next year. These medications, known as co-stimulation modulators, block the cells in the immune system from releasing inflammatory chemicals.
DiabetesExanatide is an injection based on a protein which is found, believe it or not, in the saliva of the venomous Gila monster (a type of reptile found in the western United States and Mexico). It lowers blood-glucose levels, but only when they are too high, and it may be approved for the treatment of type 2 (adult-onset) diabetes. Another drug, Synlin, a synthetic form of Amylin, a hormone secreted with insulin, may also be approved.
Dr. Reichman's Bottom Line: Just because these products are, or will be, the new ones on the block does not necessarily mean they're better than those that already exist. But they do allow you and your doctor more therapeutic choices. So let’s be thankful for what we have received in 2004 and hopeful that more pharmaceutical advances that help us fight disease and promote our health will become available in 2005.
Dr. Judith Reichman, the “Today” show's medical contributor on women's health, has practiced obstetrics and gynecology for more than 20 years. You will find many answers to your questions in her latest book, "Slow Your Clock Down: The Complete Guide to a Healthy, Younger You," published by William Morrow, a division of .
PLEASE NOTE: The information in this column should not be construed as providing specific medical advice, but rather to offer readers information to better understand their lives and health. It is not intended to provide an alternative to professional treatment or to replace the services of a physician.