Jadelle® implant
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What are the most common side effects reported with Jadelle use?
The most common side effect of Jadelle use is irregular menstrual bleeding-most women can expect some variation in menstrual bleeding patterns. Irregularities vary from woman to woman and may include prolonged menstrual bleeding (more days than a woman would normally experience), heavy bleeding, prolonged spotting or spotting between periods, no bleeding at all, or a combination of these patterns. Other adverse reactions reported by 10 percent or more of women during five years of Jadelle use in clinical trials were application site reaction, discoloration, or pain; dizziness; headache; leukorrhea (whitish discharge from the vagina and uterine cavity); mastalgia (breast pain); nausea; pelvic pain; urinary tract symptoms; vaginitis (including genital pruritus and infections); and weight gain. Women using Jadelle have also experienced acne, appetite changes, contact dermatitis, hair loss, lesions or inflammation of the cervix, libido decrease, and nervousness. Preexisting conditions of acne or excessive growth of body or facial hair could worsen. Occasionally, an infection may occur at the implant site (treatable with an antibiotic), or there may be a brief incidence of pain or itching at the insertion site. Many of these adverse events associated with use of Jadelle are commonly experienced by users of other hormonal methods. Do most Jadelle users experience side effects?
Yes, although it will frequently not be clear whether an adverse event was caused by the implants. All contraceptive methods have side effects and Jadelle is no exception. Bleeding irregularities (including spotting, longer or heavier periods than previously, or no bleeding) are reported by about 65 percent of rod users. A five-year clinical trial in seven countries showed that the two most frequent medical reasons, other than bleeding irregularities, leading to removal were headache and weight gain. About 19 per 100 women discontinued use of Jadelle because of bleeding problems.
Are bleeding irregularities associated with Jadelle serious?
A change in the menstrual bleeding pattern-the most frequently reported side effect-is to be expected with hormonal methods that do not contain estrogen. Most bleeding irregularities associated with Jadelle are not serious, although they may be troublesome for some users. If a woman experiences heavy bleeding, she should see her physician or health care provider to make sure the bleeding is not masking another condition. Because some rod users experience amenorrhea, missed menstrual periods cannot serve as the only means of identifying early pregnancy.
What kind of bleeding pattern can be expected?
It is not possible to predict the kind of bleeding pattern a woman will have while using Jadelle. Many women can expect an altered menstrual bleeding pattern to become more regular after six to nine months. Both increased and reduced bleeding tend to diminish with time, although these irregularities can persist for some women throughout the three or five years.
Is the lack of bleeding (amenorrhea) harmful?
Sometimes a woman is concerned about amenorrhea-the absence of monthly bleeding. A woman's health or future fertility will not be harmed if she does not have her period while using Jadelle; there is no blood "buildup." Pregnancy tests should be performed whenever a pregnancy is suspected. Six weeks or more of amenorrhea after a pattern of regular menses may signal pregnancy.
Does the use of Jadelle make women anemic?
Despite the increased frequency of menstrual bleeding in some women using Jadelle, the amount of total blood loss is usually less than occurs during normal menses. In some studies, in fact, hemoglobin values of Jadelle users have been shown to increase. A few rare cases of severe blood loss have been associated with anemia.
Should women be given estrogen to control bleeding and spotting?
Jadelle is estrogen-free and many women and their health care providers choose the method for this reason. Although research has been conducted to test the effectiveness of a few treatments for bleeding irregularities, there is no evidence available to promote any specific treatment.
Does Jadelle use affect lipid and carbohydrate metabolism?
Serum lipoprotein levels were altered in three clinical studies involving 544 women using Jadelle. Levonorgestrel rod users had mean decreases from baseline in total cholesterol, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol of approximately 12 percent, 14 percent, and 10 percent, respectively. Triglyceride levels decreased about 25 percent from pretreatment values. Although these decreases were statistically significant, all mean values remained within the normal ranges. The long-term clinical effects of these changes have not been determined. Women who are being treated for hyperlipidemias should be followed closely if they elect to use Jadelle. Some progestins may elevate LDL levels, thereby making the control of hyperlipidemias more difficult. The effect of levonorgestrel-containing implants on carbohydrate metabolism appears to be minimal. During the Norplant postmarketing surveillance study, diabetes mellitus developed in Norplant users at the rate of 0.2 per 1,000 woman-years, a rate not significantly above that of control subjects who were not using hormonal contraception. While the clinical significance of these findings is unknown, diabetic patients should be carefully observed while using Jadelle.
What are warning signs of possible problems?
A woman using Jadelle should return to her health care provider or clinic immediately if she has severe lower abdominal pain (possible ectopic pregnancy), heavy vaginal bleeding (masking symptoms of cervical or endometrial cancer), delayed menstrual periods after several regular cycles (possible pregnancy), pus or bleeding at the insertion site (indication of infection), or expulsion of an implant (when placement is shallow). Of course, women also should seek immediate medical attention if they have sharp chest pain, coughing of blood, or sudden shortness of breath (possible clot in the lung); pain in the calf or arm (possible clot in the leg or arm); sudden partial or complete loss of vision (possible clot in the eye); crushing chest pain or heaviness in the chest (possible heart attack); sudden severe or persistent headache or vomiting, dizziness, or fainting, disturbances of speech or blurred vision, weakness or numbness in an arm or leg (possible stroke or other neurological problem); or sleep disorders, weakness, lack of energy, fatigue, or changes in mood (possibly indicating severe depression). The absence of menstrual periods after several regular cycles may be a sign of pregnancy. If a woman is not bleeding at her expected time or has lower abdominal pain or symptoms of pregnancy, she should visit the clinic without delay. Lower abdominal pain may indicate an ectopic pregnancy. A change in the frequency, pattern, severity, or persistence of headaches, or blurred vision, may be signs of papilledema, which in turn may indicate idiopathic intracranial hypertension. Women experiencing these symptoms should discuss them with their health care provider, who may screen them for papilledema and, if the condition is present, refer them to a neurologist for further diagnosis and care. This condition, which is seen most commonly in obese women of reproductive age in the general population, has been reported in postmarketing use of Norplant in the United States and the United Kingdom. However, a causal relationship is unclear. Jadelle rods should be removed from women experiencing papilledema. Contact lens wearers who experience visual changes or changes in lens tolerance while using Jadelle should be assessed by an ophthalmologist. Women who become significantly depressed while using Jadelle should discuss with their health care provider whether the rods should be removed.
Are there other health considerations with Jadelle use?
Women with certain health conditions can use Jadelle, provided they have regular checkups. If a woman has any of the following conditions, she should discuss them with her health care provider before using the rods: breast nodules, fibrocystic disease of the breast, or an abnormal breast x-ray or mammogram; diabetes; elevated cholesterol or triglycerides; high blood pressure; migraine or other headaches; epilepsy; mental depression; gallbladder, heart, or kidney disease; or a history of blood clots, heart attack, or stroke.
Does Jadelle cause heart or vascular problems?
There have been reports of superficial phlebitis in clinical trials of Jadelle and postmarketing reports of thrombophlebitis and superficial phlebitis coincident with Norplant use, more commonly in the arm of insertion. In such cases, the implants should be removed. Removal should also be considered in women who will be subjected to prolonged immobilization because of surgery or illness. There have also been reports of other thromboembolic disorders and cardiovascular problems (such as stroke, myocardial infarction, pulmonary embolism, and deep-vein thrombosis) coincident with Norplant use. In the Norplant postmarketing surveillance study, which observed more than 30,000 woman-years of Norplant use and comparable experience in women not using hormonal contraception, no myocardial infarctions occurred in either group. It is expected that this experience applies equally to Jadelle. An increased risk of thromboembolic and thrombotic disease (pulmonary embolism, superficial venous thrombosis, and deep-vein thrombosis) has been associated with the use of combination oral contraceptives. Combined oral contraceptives, which contain both estrogen and progestin, have been shown to increase both the relative and attributable risks of thrombotic and hemorrhagic strokes, although the risk is greatest among women over 35 years of age who are hypertensive (have high blood pressure) and also smoke.
Does Jadelle use increase blood pressure?
Increased blood pressure has been reported in users of combined oral contraceptives. The prevalence of elevated blood pressure increases with long exposure. Although no clinically significant rises in mean blood pressure occurred among Jadelle users in clinical trials, physicians should be aware of the possibility of elevated blood pressure in women using this method. In the Norplant surveillance study, the incidence of hypertension and borderline hypertension was moderately higher in Norplant users compared with women in the control groups. Because Norplant users had more frequent blood pressure measurements than controls, the results might partially reflect a reporting bias.
Does Jadelle cause autoimmune diseases?
Autoimmune diseases such as scleroderma, systemic lupus, and rheumatoid arthritis occur in the general population and more frequently among women of childbearing age. There have been rare reports of various autoimmune diseases, including the ones listed above, in users of the six-capsule Norplant implants; however, the rate of reporting is significantly lower than the expected incidences for these diseases in the general population. Studies have raised the possibility of antibodies being developed against silicone-containing devices; however, the specificity and clinical relevance of these antibodies are unknown. While it is believed that the occurrence of autoimmune diseases among Norplant capsule users is coincidental, health care providers should be alert to the earliest manifestations of such diseases in Jadelle users. In the Norplant postmarketing surveillance study, no significant difference in the risk of autoimmune disease was found between Norplant users and users of nonhormonal methods.
Does Jadelle use increase the risk of gallbladder disease?
Some studies have reported an increased lifetime relative risk of gallbladder disease in users of oral contraceptives and estrogens. More recent studies, however, have shown that the relative increased risk of developing gallbladder disease among oral contraceptive users is minimal. These recent findings may be related to the lower doses of estrogens and progestins in current pill formulations. In the Norplant postmarketing surveillance study, the relative risk of gallbladder disease was moderately higher in Norplant users in Chile and China compared with women in the control groups.
Does Jadelle cause birth defects?
Extensive epidemiological studies have revealed no increased risk of birth defects in the children of women who have used oral contraceptives before pregnancy. Studies also fail to suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb-reduction defects are concerned, when oral contraceptives are used inadvertently during early pregnancy. There is no evidence suggesting that the risk associated with Jadelle or Norplant use is different from the risk associated with oral contraceptives. There were no reports of birth defects for the live births that occurred during use of Jadelle in clinical trials. However, in postmarketing use of Norplant capsules, congenital anomalies have been reported in the offspring of women who used the method inadvertently during early pregnancy. A cause and effect relationship has not been established. If a woman becomes pregnant while using Jadelle, the rods should be removed immediately.
Can a smoker use Jadelle?
Cigarette smoking increases the risk of heart attacks and strokes in users of combined oral contraceptives. This risk increases with age and with heavy smoking (15 or more cigarettes a day) and is quite marked women over 35 years old. While this is believed to be an estrogen-related effect, it is not known whether similar risk exists with progestin-only methods such as Jadelle. A woman who chooses to use Jadelle advised not to smoke.
Does Jadelle protect against sexually transmitted diseases?
No. This form of contraception does not protect against HIV/AIDS or other sexually transmitted diseases. If a woman who elects to use Jadelle thinks she might be at risk for STDs, she or her partner should use a condom in addition to the rods.
Does Jadelle cause cancer at the incision site?
In rare instances cancers have occurred at the site foreign-body intrusions or old scars. None have been reported in Norplant users or in clinical trials with Jadelle. In rodents, which are highly susceptible such cancers, the incidence decreases with decreasing size of the foreign body. Because of the resistance of humans to these cancers and because of the small size of the implants, the risk to users of Jadelle judged to be minimal.
Can a woman use Jadelle if she is breastfeeding?
Hormones are not considered the most appropriate contraceptives for breastfeeding women. However, studies have shown no significant effects on the growth or health of infants whose nursing mothers began using levonorgestrel implants five to seven weeks after childbirth. There is no experience to support the use of Jadelle earlier than six weeks after childbirth in lactating women.
Is sickle cell anemia a contraindication?
Sickle cell anemia is not considered a contraindication for the use of Jadelle. However, the Population Council does not have relevant data from clinical trials since women who were anemic were not included in the Council’s studies with Norplant capsules or with Jadelle. One published study indicated that women with sickle cell anemia did not suffer adverse effects when using Norplant capsules.
Do other drugs interact with Jadelle?
Certain drugs may interact with the hormone delivered by Jadelle to make the rods less effective in preventing pregnancy. These include drugs used for epilepsy such as phenytoin (like Dilantin), carbamazepine, and oxcarbazepine. When considering Jadelle use, a woman should tell her health care provider if she is taking any of these or other medications. Rifampin is known to decrease the effectiveness of combination oral contraceptives; its effect on levonorgestrel concentrations is unknown.
Is there a risk of ectopic pregnancy?
The absolute risk of ectopic pregnancy (a fetus developing outside the uterus) during use of Jadelle is very low, because of the high effectiveness of the method. Ectopic pregnancies occur with Jadelle at a rate of less than 0.5 per 1,000 woman-years. Clinical and controlled postmarketing studies of Norplant users showed no increase in the rate of ectopic pregnancies per year as compared with women using IUDs, oral contraceptives, condoms, or no method at all. Physicians should be alert to the possibility of an ectopic pregnancy among women using Jadelle who become pregnant or complain of lower abdominal pain. Any patient who presents with lower abdominal pain must be evaluated to rule out ectopic pregnancy.
Are ovarian cysts a problem for Jadelle users?
Functional ovarian cysts or enlarged follicles occur in levonorgestrel implant users more frequently than they do in women who do not use Jadelle or Norplant. If follicles become enlarged, they may produce some discomfort in some women, although most users would not be aware of them unless they were found during a physical exam. In the majority of women affected, enlarged follicles will spontaneously disappear and do not require surgery. Rarely, they may twist or rupture, sometimes causing abdominal pain, so that surgery is required.
Are there known long-term side effects?
No studies of long-term health effects from either Jadelle or Norplant use have been conducted beyond five years. However, the drug contained in both types of implants—levonorgestrel—has been used in oral contraceptives for over 30 years.
What is known about medium-term health effects of Jadelle use?
The best evidence of medium-term health effects comes from the five-year Norplant postmarketing surveillance. The surveillance compared some 8,000 Norplant users with about 8,000 users of either IUDs or sterilization in eight developing countries. The women were followed for five years, even if they discontinued use of the method, switched to another, or became pregnant. Norplant was not associated with any material risk of major morbidity compared with the two control groups. For greater detail, see the section on the postmarketing surveillance in this monograph.
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