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- Newsgroups: sci.med
- Path: sparky!uunet!spool.mu.edu!yale.edu!yale!gumby!destroyer!news.iastate.edu!bron
- From: bron@iastate.edu (bronwyn)
- Subject: Re: Norplant side effects
- Message-ID: <C02K1E.JKK@news.iastate.edu>
- Originator: bron@tbird.cc.iastate.edu
- Sender: news@news.iastate.edu (USENET News System)
- Organization: Iowa State University, Ames, IA
- References: <1992Dec29.100313.1@sscvx1.ssc.gov>
- Date: Wed, 30 Dec 1992 11:03:13 GMT
- Lines: 197
-
- In article <1992Dec29.100313.1@sscvx1.ssc.gov> abraham@sscvx1.ssc.gov writes:
- >What are the side effects of using 'Norplant' for birth control ?
-
- Personally, I've experienced few. The most obvious one I've experienced is
- a reduction in the frequency of my period. Oh, how 'orrible ;) ;) ;)
- I have full patient labeling for interested parties.
-
- Information below is reproduced without permission from Wyeth-Ayerst
- Laboratories patient labeling for the Norplant System (r):
-
- Risks of Using the Norplant System
- ----------------------------------
-
- 1. Irregular Menstrual Bleeding
- Most women experience some change in their usual monthly pattern.
- These menstrual irregularities vary from woman to woman and
- include:
- * Prolonged bleeding (more days than you usually experience),
- commonly during the first months of use;
- * Untimely bleeding or spotting between periods;
- * No bleeding at all for several months; or
- * A combination of these patterns.
- It cannot be predicted what kind of change you may experience. If
- increased frequency of bleeding occurs, the quantity of blood lost
- is rarely enough to cause anemia, but there have been a few cases
- that required treatment. The irregularities frequently diminish
- gradually with continued use.
-
- 2. Delayed Disintegration or Disappearance of Follicles
- If follicles (eggs and their surrounding cells) in the ovary
- develop while using the Norplant System, disintegration or
- disappearance of the follicles is sometimes delayed, and the
- follicles may continue to grow beyond the size they would normally
- reach. These enlarged follicles may produce discomfort in some
- women, although most users would not be aware of them unless they
- were found incidentally on a physical exam. In the majority of
- women, enlarged follicles will disappear on their own and should
- not require major surgery. Rarely, they may twist or rupture so
- that surgery is required. You should discuss this with your
- health-care provider.
- 3. Ectopic Pregnancies
- Ectopic pregnancies (development of the fertilized egg outside the
- uterus) have occurred among Norplant System users, although
- clinical studies have shown no increase in the rate of ectopic
- pregnancies per year among Norplant System users as compared with
- users of no method or of IUDs. Symptoms of an ectopic pregnancy
- include spotting and cramping pain, which usually begin shortly
- after the first missed period. Contact your health-care provider
- should you miss a period or experience abdominal pain.
- 4. Risks Based on Experience with Combination Oral Contraceptives
- Combination pills contain a progestin such as levonorgestrel and
- an estrogen, another type of hormone. Some rare but serious side
- effects have been associated with the use of the combination pill.
- It is unknown whether the risks associated with combined
- oral-contraceptive use may also be risks with a progestin-only
- contraceptive like the Norplant System. Since the hormone is
- released at a low rate, the Norplant System is expected to avoid
- some of the side effects of combined oral contraceptives that not
- only have higher progestin doses but also contain estrogen.
- Risks Associated with Combination Oral Contraceptives Include:
- a. Risk of developing blood clots - Blood clots and blockage of
- blood vessels are the most serious side effects of taking the
- combination pill. In particular, a clot in the veins of the
- legs can cause inflammation and risk of further clots, and a
- clot that travels to the lungs can cause a sudden blocking of
- the vessel carrying blood to the lungs, resulting in
- respiratory collapse and even death. Rarely, clots occur in
- the blood vessels of the eye and may cause double vision,
- impaired vision, or even blindness.
- b. Risk of heart attacks and strokes - The combination pill may
- increase the tendency to develop strokes (stoppage or rupture
- of blood vessels in the brain), angina pectoris, or heart
- attacks (blockage of blood vessels to the heart). Any of
- these conditions can cause death or serious disability.
- Smoking greatly increases the probability of suffering heart
- attacks and stroke.
- Use of combination oral contraceptives together with
- cigarette smoking greatly increases the risk of serious
- adverse effects on the heart and blood vessels.
- This risk increases with age and with heavy smoking (15 or
- more cigarettes per day) and is quite marked in women over 35
- years of age who smoke. It is not known whether a similar
- interaction occurs with the Norplant System. Therefore, women
- who use the Norplant System should not smoke.
- c. Gallbladder disease - Combined-pill users probably have a
- greater risk than nonusers of gallbladder disease. Since this
- risk may be related to pills containing high doses of
- estrogens, it may not be a concern for Norplant System users.
- d. Liver tumors - In rare cases, the combination oral
- contraceptive can cause noncancerous but dangerous liver
- tumors. These benign liver tumors can rupture and cause fatal
- internal bleeding. In addition, a possible but not definite
- association has been found with the pill and liver cancers.
- However, liver cancers are very rare.
- e. Cancer of the reproductive organs - There is, at present, no
- confirmed evidence that combination oral contraceptives
- increase the risk of cancer of the reproductive organs in
- human studies. Recent studies have found no increased risk of
- developing breast cancer in the overall population of users.
- However, some of these same recent studies have found that
- certain subgroups of oral-contraceptive users may be at an
- increased risk, although no consistent pattern has been
- identified. Some studies have found an increase in the
- incidence of cancer of the cervix in women who use oral
- contraceptives. However, this finding may be related to
- factors other than the use of oral contraceptives.
-
-
- Side Effects of the Norplant System
- -----------------------------------
-
- The most frequently reported side effects are menstrual cycle
- irregularities. Such changes vary from woman to woman and may
- include:
- * Prolonged menstrual bleeding (more days than you would usually
- experience), commonly during the first months of use;
- * Untimely bleeding or spotting between periods;
- * No bleeding at all for several months; or
- * A combination of these patterns.
-
- It cannot be predicted before insertion of the Norplant System
- what kind of bleeding pattern you will have. Many women can expect
- an altered bleeding pattern to become more regular after 9 to 12
- months. Despite the increased frequency of bleeding in some women,
- the monthly blood loss is usually less than normal menses. In fact,
- in some studies, patient blood counts have improved.
- Contact your health-care provider if you experience heavy
- bleeding. If you have normal cyclic periods and then miss a period,
- a pregnancy test should be obtained.
- In clinical studies, women using the Norplant system have
- complained about the following conditions, which are possibly
- related to the Norplant System:
- * Headache;
- * Nervousness;
- * Nausea;
- * Dizziness;
- * Enlargement of the ovaries and/or fallopian tubes;
- * Dermatitis (inflammation of the skin);
- * Acne;
- * Change of appetite;
- * Weight gain;
- * Mastalgia (breast tenderness);
- * Hirstutism (excessive growth of body or facial hair) or
- alopecia (hair loss);
- * Discoloration of the skin over the site of implantation
- (usually reversible).
-
- Preexisting conditions of acne or excessive growth of body or
- facial hair could also be worsened. Occasionally, an infection may
- occur at the implant site, or there may be a brief incidence of
- pain or itching. Removals may be more difficult than insertions in
- some cases.
- An enlargement of ovarian follicles, detectable during a physical
- examination, sometimes occurs in Norplant system users. The
- enlarged follicles usually disappear on their own without surgical
- intervention, but in rare instances they may twist or rupture, so
- that surgery is required.
- There are a number of other complaints reported by Norplant
- System users or discovered by health-care providers, but an
- association with the Norplant System has been neither confirmed nor
- refuted:
- * Breast discharge;
- * Cervicitis (inflammation of the cervix, detected by physician);
- * Muscle and skeletal pain;
- * Abdominal discomfort;
- * Leukorrhea (whitish discharge from the vagina and uterine
- cavity);
- * Vaginitis (inflammation of the vagina).
-
-
- Side Effects Based on Experience with Combination Oral
- Contraceptives
- --------------
-
- As with the risks associated with taking combination oral
- contraceptives, it is unknown whether the possible side effects
- listed below would also occur with a progestin-only contraceptive
- like the Norplant System.
- a. Contact lenses - If you wear contact lenses and notice a
- change in vision or an inability to wear your lenses, contact
- your doctor or health-care provider.
- b. Fluid retention - Combination 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 health-care provider.
- c. Melasma - A spotty darkening of the skin is possible,
- particularly of the face.
- c. Other side effects - Other side effects that have been
- observed with the use of combination oral contraceptives, but
- not necessarily the Norplant System, include depression and
- rash.
-
-
- --
- Bronwyn J Scrutton bron@iastate.edu
- Project Vincent (515) 294-4994
- If it's not one thing, it's Bronwyn.
-