Drug Uses
Seasonale is used to prevent pregnancy. This medication does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
How Taken
Take one pill at the same time every day until you have taken the last pill in the tablet dispenser. Do not skip pills even if you are spotting or bleeding or feel sick to your stomach. Do not skip pills even if you do not have sex very often.
Warnings/Precautions
If you are breastfeeding, consult your healthcare provider before starting oral contraceptives. Some of the drug will be passed on to the child in the milk.
Missed Dose
If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. Try not to exceed 24 hours between pills.
Possible Side Effects
Seasonale may cause your blood pressure to rise. A spotty darkening of the skin is possible, particularly of the face. Other, less serious side effects you may experience include nausea and vomiting, change in appetite, breast tenderness, headache, nervousness, depression, dizziness, loss of scalp hair, rash, vaginal infections, and allergic reactions.
Storage
Store at controlled room temperature 20°-25° C (68°-77° F). Keep out of the reach of children.
Overdose
Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your healthcare provider or pharmacist.
More Information
Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. You should be reexamined at least once a year.
Disclaimer
This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.
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July 24, 2007 -- An expert panel gave its OK for expanded use of the osteoporosis drug Evista Tuesday, telling the FDA that the drug appears effective in preventing some breast cancer.
If the agency follows the panel's advice, it would clear the way for the drug, also called raloxifene, to be legally sold as a cancer prevention agent to millions of women.
It would also position the drug as an alternative to the anti-estrogen drug tamoxifen, which has long been used to help fight breast cancer's return. In 1998, the FDA approved tamoxifen for use by women who hadn't had breast cancer but were at high risk of developing the disease.
Breast cancer is the second leading cause of cancer death among women, and about 40,500 American women will die from breast cancer in 2007, according to the American Cancer Society. About 13% of women are estimated to develop breast cancer in their lifetime, according to the National Cancer Institute.
"Postmenopausal women at high risk for invasive breast cancer, I think now should have a choice," says George Sledge, MD, a professor of medicine at Indiana University. Sledge is also a consultant for Eli Lilly & Co, the maker of Evista.
Experts voted 10-4, with one abstaining, to recommend that Lilly be allowed to market Evista's ability to cut the likelihood of breast cancer in postmenopausal women at high risk for tumors. A company study showed that raloxifene and tamoxifen are equally effective at reducing the risk of cancer in those women.
"I do believe raloxifene is effective in reducing breast cancer," says panelist Otis Brawley, MD, a professor of oncology at Emory University School of Medicine.
Close Decision
The panel voted 8 to 6, with one abstention, on whether Lilly should be allowed to promote Evista's possible cancer-fighting abilities to all postmenopausal women with osteoporosis.
Three studies filed by the company all showed that women who took Evista for up to five years developed fewer invasive breast cancers than women who took a placebo. But women who took the drug also had a higher risk of serious blood clots and fatal stroke.
An FDA analysis of the three studies was inconclusive as to whether Evista's potential benefits outweighed its risks. Agency officials said they were troubled because Lilly had not submitted any data showing whether women who take Evista actually live longer than those who don't.
"It is uncertain if the balance of benefits and risk factors for women at high risk is favorable because the magnitude of benefits is unknown," says Patricia Cortazar, MD, an FDA safety official.
Potential Risks
Several breast cancer advocacy groups opposed the approval. Carolina Hinestrosa, executive vice president of the Breast Cancer Coalition, says the government should boost efforts to find causes of breast cancer rather than approving drugs with relatively small benefits.
"Considering that most women will not develop breast cancer in their lifetimes ... taking raloxifene and tamoxifen as a risk reduction measure will be unnecessary for most," she says.
Some panelists urged the FDA to restrict the drug's marketing, particularly to keep it out of the hands of women at risk for cardiovascular disease. One panelist even suggested issuing a "black box" warning for Evista.
"There should be a strong effort to limit potential harm," says Curt D. Furburg, MD, a Wake Forest University professor of public health who voted to approve the new use for Evista.
Lilly paid $36 million in fines in 2005 after pleading guilty to illegally promoting Evista as a cancer-fighting drug. Critics said approving the new use for the drug would clear the way for the company to promote the drug with direct-to-consumer advertising.
Gwen Krivi, PhD, vice president of Lilly Research Laboratories, says the company will "continue working with the FDA to make this important option a reality for patients."
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