ANNUAL NUMBER OF BIRTH-RELATED OR METHOD-RELATED DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NON-STERILE WOMEN, BY FERTILITY CONTROL METHOD ACCORDING TO AGE
Method of control and outcome				15-19				20-24				25-29				30-34				35-39				40-44
No fertility control methods*				7.0				7.4				9.1				14.8				25.7				28.2
Oral contraceptives non-smoker**				0.3				0.5				0.9				1.9				13.8				31.6
Oral contraceptives smoker**				2.2				3.4				6.6				13.5				51.1				117.2
IUD**				0.8				0.8				1.0				1.0				1.4				1.4
Condom*				1.1				1.6				0.7				0.2				0.3				0.4
Diaphragm/spermicide*				1.9				1.2				1.2				1.3				2.2				2.8
Periodic abstinence*				2.5				1.6				1.6				1.7				2.9				3.6

**Deaths are birth related
**Deaths are method related

In the table on the preceding page, the risk of death from any birth control method is less than the risk of childbirth, except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen in the table that for women aged 15 to 39, the risk of death was highest with pregnancy (7–26 deaths per 100,000 women, depending on age). Among pill users who do not smoke, the risk of death is always lower than that associated with pregnancy for any age group, although over the age of 40, the risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the age of 35, the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is four times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group.

The suggestion that women over 40 who do not smoke should not take oral contraceptives is based on information from older, higher-dose pills. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of low-dose oral contraceptive use by healthy, non-smoking women over 40 years of age may outweigh the possible risks.

When taking oral contraceptives, are there certain warning signals that the doctor should know about immediately?

If any of these adverse effects occur while you are taking oral contraceptives, call your doctor or clinic immediately:

• Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)
  
  
• Pain in the calf (indicating a possible clot in the leg)
  
  
• Crushing chest pain or heaviness in the chest (indicating a possible heart attack)
  
  
• Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)
  
  
• Sudden partial or complete loss of vision (indicating a possible clot in the eye)
  
  
• Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your doctor or clinic to show you how to examine your breasts)
  
  
• Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor)
  
  
• Difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)
  
  
• Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark colored urine, or light colored bowel movements (indicating possible liver problems).

What are the side effects of oral contraceptives?

1. Vaginal bleeding
Irregular vaginal bleeding or spotting may occur while you are taking the pills. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle or lasts for more than a few days, talk to your doctor or clinic.

2. Contact lenses
If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or clinic.

3. Fluid retention
Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your doctor or clinic.

4. Melasma
A spotty darkening of the skin is possible, particularly of the face, which may persist.

5. Other side effects
Other side effects may include nausea and vomiting, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections.

If any of these side effects bother you, call your doctor or clinic.

Are there any general precautions?

1. Missed periods and use of oral contraceptives before or during early pregnancy
There may be times when you may not menstruate regularly after you have completed taking a cycle of pills. If you have taken your pills regularly and miss one menstrual period, continue taking your pills for the next cycle but be sure to inform your doctor or clinic before doing so. If you have not taken the pills daily as instructed and missed a menstrual period, you may be pregnant. If you missed two consecutive menstrual periods, you may be pregnant. Check with your doctor or clinic immediately to determine whether you are pregnant. Do not continue to take oral contraceptives until you are sure you are not pregnant, but continue to use another method of contraception.

There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects, when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects, but these findings have not been seen in more recent studies. Nevertheless, oral contraceptives or any other drugs should not be used during pregnancy unless clearly necessary and prescribed by your doctor or clinic. You should check with your doctor or clinic about risks to your unborn child of any medication taken during pregnancy.

2. While breast feeding
If you are breast feeding, consult your doctor or clinic before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, oral contraceptives may decrease the amount and quality of your milk. If possible, do not use oral contraceptives while breast feeding. You should use another method of contraception since breast feeding provides only partial protection from becoming pregnant and this partial protection decreases significantly as you breast feed for longer periods of time. You should consider starting oral contraceptives only after you have weaned your child completely.

3. Laboratory tests
If you are scheduled for any laboratory tests, tell your doctor or clinic you are taking birth control pills. Certain blood tests may be affected by birth control pills.

4. Drug interactions
Certain drugs may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Such drugs include rifampin, drugs used for epilepsy such as barbiturates (for example, phenobarbital), anticonvulsants such as carbamazepine (Tegretol is one brand of this drug), phenytoin (Dilantin is one brand of this drug), phenylbutazone (Butazolidin is one brand), and possibly certain antibiotics. You may need to use additional contraception when you take drugs which can make oral contraceptives less effective.

THIS PRODUCT (LIKE ALL ORAL CONTRACEPTIVES) IS INTENDED TO PREVENT PREGNANCY. IT 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.

Important: Before taking Desogen® (desogestrel and ethinyl estradiol) Tablets, please read all of the detailed patient labeling.

How do I take Desogen®?

This is the easy part. The Desogen
pill dispenser is designed to make taking your pills simple and convenient.

Before you start taking your pills:

1. Be sure to read these directions
anytime you are not sure what to do.

2. The right way to take the pill is to take one pill every day at the same time.
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.

3. Many women have spotting or light bleeding, or may feel sick to their stomach during the first 1–3 packs of pills.
If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn’t go away, check with your doctor or clinic.

4. Missing pills can also cause spotting or light bleeding, even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.

5. If you have vomiting or diarrhea, for any reason, or if you take some medicines, including some antibiotics, your pills may not work as well. Use a back-up method (such as condoms, foam, or sponge) until you check with your doctor or clinic.

6. If you have trouble remembering to take the pill, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control.

7. If you have any questions or are unsure about the information in this leaflet, call your doctor or clinic.

Before you take your first pill:

1. Decide what time of day you want to take your pill.
It is important to take it at about the same time every day.

2. Look at your pill pack.
Your 28-pill pack has 21 “active” [white] pills (with hormones) to take for 3 weeks, followed by 1 week of reminder [green] pills (without hormones).

3. Also find:

1. where on the pack to start taking the pills,
   
   
2. in what order to take the pills (follow the arrows), and
   
   
3. the week numbers printed on the pack.

4. Be sure you have ready at all times:
Another kind of birth control (such as condoms, foam, or sponge) to use as a back-up in case you miss pills.

An extra, full pill pack.

When to start the first pack of pills:

You have a choice of which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember.

Day 1 start:

1. Pick the day label strip that starts with the first day of your period (this is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins).
   
   
2. Place this day label strip in the cycle tablet dispenser over the area that has the days of the week (starting with Sunday) imprinted in the plastic.
   
   Note: If the first day of your period is a Sunday, you can skip steps #1 and #2.
   
   
3. Take the first “active” [white] pill of the first pack during the first 24 hours of your period.
   
   
4. You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period.

Sunday Start:

1. Take the first “active” [white] pill of the first pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day.
   
   
2. Use another method of birth control as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). Condoms, foam, or the sponge are good back-up methods of birth control.

What to do during the month:

1. Take one pill at the same time every day until the pack is empty.

Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).

Do not skip pills even if you do not have sex very often.

2. When you finish a pack or switch your brand of pills:

21-pill pack of your previous brand: Wait 7 days to start the next pack. You will probably have your period during that week. Be sure that no more than 7 days pass between finishing your 21-day pack and starting your 28-day Desogen® (desogestrel and ethinyl estradiol) Tablets pack.

28-pill pack of your previous brand or Desogen®: Start the next pack on the day after your last “reminder” pill. Do not wait any days between packs.

What to do if you miss pills:

If you miss 1 [white] “active” pill:

1. Take it as soon as you remember. Take the next pill at your regular time. This means you take 2 pills in 1 day.
   
   
2. You do not need to use a back-up birth control method if you have sex.

If you miss 2 [white] “active” pills in a row in Week 1 or Week 2 of your pack:

1. Take 2 pills on the day you remember and 2 pills the next day.
   
   
2. Then take 1 pill a day until you finish the pack.
   
   
3. You may become pregnant if you have sex in the 7 days after you miss pills. You must use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days.

If you miss 2 [white] “active” pills in a row in the 3rd Week:

1) If you are a Day 1 Starter:
Throw out the rest of the pill pack and start a new pack that same day.

If you are a Sunday Starter:
Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day.

2) You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.

3) You may become pregnant if you have sex in the 7 days after you miss pills. You must use another birth control method (such as condoms, foam, or sponge) as a back-up for those 7 days.

If you miss 3 or more [white] “active” pills in a row (during the first 3 weeks):

1) If you are a Day 1 Starter:
Throw out the rest of the pill pack and start a new pack that same day.

If you are a Sunday Starter:
Keep taking 1 pill every day until Sunday.

On Sunday, throw out the rest of the pack and start a new pack of pills that same day.

2) You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.

3) You may become pregnant if you have sex in the 7 days after you miss pills. You must use another birth control method (such as condoms, foam, or sponge) as a back-up method for those 7 days.

A reminder:

If you forget any of the 7 [green] “reminder” pills in Week 4:

Throw away the pills you missed.

Keep taking 1 pill each day until the pack is empty.

You do not need a back-up method.

Finally, if you are still not sure what to do about the pills you have missed:

Use a back-up method anytime you have sex.

Keep taking one [white] “active” pill each day until you can reach your doctor or clinic.

In addition to providing effective birth control, do Desogen® (desogestrel and ethinyl estradiol) Tablets offer any health benefits?

Desogen®, like other oral contraceptives, may provide certain of the following health benefits:

• menstrual cycles may become more regular
  
  
• blood flow during menstruation may be lighter and less iron may be lost; therefore, anemia due to iron deficiency is less likely to occur
  
  
• pain or other symptoms during menstruation may be encountered less frequently
  
  
• ectopic (tubal) pregnancy may occur less frequently
  
  
• noncancerous cysts or lumps in the breast may occur less frequently
  
  
• acute pelvic inflammatory disease may occur less frequently
  
  
• oral contraceptive use may provide some protection against developing two forms of cancer: cancer of the ovaries and cancer of the lining of the uterus

Please refer to the product information sheet enclosed with your Desogen® pill dispenser for further information. Consult your doctor or health care provider if you have any questions about Desogen®.

Oral contraceptives are known to promote a number of health benefits. However, serious as well as minor side effects have also been reported following the use of all oral contraceptives. See the detailed patient information that follows or consult your doctor or health care provider for more details.