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Contraceptive methods, including implants, do not prevent common symptoms and adverse health events that most people experience. It is difficult, therefore, to decide whether or not the occurrence of symptoms or adverse events that are common can be attributed to use of a contraceptive method or to determine if a given method changes the likelihood of their occurrence. Based on the review of the literature, no apparent differences in the frequency of adverse events are evident between the six-implant or two-rod levonorgestrel systems and the single implant etonogestrel and nomegestrol acetate systems. The most frequent adverse events reported in clinical trials that are probably related to implant use are headaches and acne. Weight gain, dizziness, and mood changes are also frequently mentioned adverse events and are possibly steroid-related. Other possibly related adverse events, although much less frequently reported, are loss of libido, fatigue, hair loss, and other skin conditions. Persistent ovarian follicles that spontaneously disappear are a common event during use of progestin-only contraceptives, and providers should be aware of this condition to avoid unnecessary interventions. Overall, the vast experience reported in the clinical studies reviewed here show that all existing implantable contraceptives are equally safe. This can probably be attributed to the low-hormonal dose delivered by progestin-implant systems.
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PMID:Nonmenstrual adverse events during use of implantable contraceptives for women: data from clinical trials. 1186 Oct 56

The ideal antihypertensive drug should be effective in reducing blood pressure, but have a low incidence of adverse effects. Angiotensin II receptor blockers, such as eprosartan, are as effective as ACE inhibitors in reducing blood pressure, but lack the main adverse effect of ACE inhibitors, namely cough. Eprosartan has been shown to be well tolerated with a placebo-like adverse-effect profile. When given as monotherapy it is effective in reducing blood pressure; however, some patients require additional blood pressure control, which may be provided by combination therapy. Indeed, the combination of eprosartan and the thiazide diuretic hydrochlorothiazide has been shown to be effective in further reducing blood pressure in patients not optimally responding to eprosartan monotherapy. This article reviews the safety and tolerability of eprosartan in combination with hydrochlorothiazide from 17 studies of 1899 patients with hypertension and normotensive volunteers. Of these studies, four were controlled with patients receiving a fixed-dose combination, six were long-term, open-label, and another four were controlled studies with hydrochlorothiazide being given to eprosartan non-responders. The other three studies included healthy subjects receiving the combination of eprosartan and hydrochlorothiazide. There was a high completion rate in all studies evaluated. Most of the patients receiving eprosartan 600mg in combination with hydrochlorothiazide 12.5mg daily completed the studies, which supports acceptance of this combination therapy by patients. The most frequently reported adverse events in these combination studies were headache, dizziness, myalgia, and upper respiratory tract infection in patients with hypertension. The majority of adverse events were mild to moderate in intensity, and were not considered to be related to study treatment. The adverse event that was more common in patients receiving combination therapy compared with those receiving monotherapy was dizziness. This adverse event may be due to hydrochlorothiazide as it has previously been observed in patients taking thiazide diuretics. In healthy volunteers, the most frequently reported adverse events were headache, dizziness, and upper respiratory tract infection. However, none of these adverse events were considered related to study medication. In summary, the combination of eprosartan/hydrochlorothiazide is well tolerated, both as short- and long-term therapy, with most adverse events occurring early. The most frequent adverse events were headache, dizziness, and upper respiratory infection, which would be expected based on the safety profile of each of the components. Therefore, the combination of eprosartan with hydrochlorothiazide can be effectively and safely used in patients not adequately responding to eprosartan monotherapy.
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PMID:Safety and tolerability of eprosartan in combination with hydrochlorothiazide. 1211 44

The use of depo-medroxyprogesterone acetate (DMPA), or Depo Provera, has been debated for the 20 years since it became available in 1967. The US Food and Drug Administration (FDA) refused to approve Depo Provera on the basis that it caused breast tumors in a controlled study of Beagle dogs and Rhesus monkeys conducted by Upjohn, the manufacturer. Depo Provera has been approved in over 60 other countries and is in use in 30 or 40 others with an estimated total of almost 5 million users. A natural hormone, progesterone, DMPA is injected intramuscularly and absorbed slowly. Common dosage is 150 mg every 3 months and usually is administered during the 1st week of the menstrual cycle. The pregnancy rate with Depo Provera is .44 pregnancies/100 women years for women receiving 100 mg every 3 months. No pregnancies were recorded in recent studies for women receiving 150 mg. Possible side effects include amenorrhea, weight gain, dizziness and headaches. The median time for contraception after the presumed duration of one's last injection is 5-1/2 months. Some countries only permit women who already have 1 child to use Depo Provera. The FDA in the US approves the use of Depo Provera for treatment of endometrial and renal cancer but accuses it of causing cancer in Beagles and Rhesus monkeys. The studies were conducted over 7 and 10-year periods, respectively, with extremely negative results including the death of 3 dogs due to "drug-induced diabetes," atrophication of adrenal glands, and malignant tumors. There were similar results for the monkey study. In the UK, the Committee for Safety in Medicine supports Upjohn's view that Beagles are unsuitable for comparison testing because "all dogs are acutely sensitive to progesterone." Groups such as the National Women's Health Network, the institute for Food and Development Policy, and "Mother Jones" have used the media to generate opposition to Depo Provera, citing a double standard for rich and poor women, developed and less developed countries. The proponents of Depo Provera criticize health activists for imposing their own standards on women in developing countries. Regarding concerns about greater risk of Acquired Immune Deficiency Syndrome (AIDS), Depo Provera can be injected with disposable needles. In response to the controversy, Upjohn withdrew its application to the FDA in September 1986 but intends to resubmit with new information from a World Health Organization report, which showed no evidence of an increased risk of cancers of the endometrium, liver, or breast.
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PMID:Depo Provera: still controversial. 1217 73

A study of intramuscular injections of depo medroxyprogesterone acetate (Depo Provera) as a postpartum contraceptive was undertaken in an attempt to determine the following: 1) the continuation rates for this contraceptive method in a postpartum family planning program; 2) to compare the continuation rates of Depo Provera given as a postpartum contraceptive with other postpartum contraceptive methods, as reported elsewhere; 3) the use-effectiveness of Depo Provera as a postpartum contraceptive method; 4) the side effects of postpartum injections; and 5) the reasons for discontinuation of this method. Between April 1969 and May 31, 1972 there were a total of 325 acceptors at the Family Planning Department of McCormick Hospital in Chiang Mai, Thailand. 217 of the women were acceptors of 3-month injections and 108 women were acceptors of 6-month injections. Of all acceptors, 94.2% received their 1st injection within 5 days of delivery. Cases continuing beyond 12 months were too few in number for significant statistical analysis. There were no known method failure pregnancies. Of the 325 postpartum acceptors of the 3-month and 6-month Depo Provera injections, 152 had discontinued the method by May 31, 1972. Of these, 47 were lost to follow up. The reasons for the discontinuation of the 105 remaining cases were bleeding problems (amenorrhea, prolonged, frequent or heavy bleeding, and irregular periods), other medical reasons (palpitation and dizziness, abdominal pain, pain at injection site, and melasma), and personal reasons.
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PMID:Use of a long-acting injectable contraceptive in a postpartum family planning program. 1226 37

In the 1974-86 period, gossypol acetate was taken as an antifertility measure by 16 men. The initial dose was 20 mg/day, with a maintenance dose of 40 mg/week. Antifertility efficacy was obtained in all 16 cases. Azoospermia persisted in 1 case where the gossypol had been taken for 8 years and discontinued for the past 2 1/2 years. Symptoms experienced in the first 2 weeks of gossypol acetate administration included dizziness, anorexia, nausea, fatigue, and stomach discomfort. Results of examinations of blood and urine; functions of the heart, liver, lung, and liver; electrolytes; external genitalia; and sexual performance were all in the normal range. Measurements of semen, plasma biochemistry, and endocrine changes also were within normal limits. However, in the 9 cases in which the average value of plasma testosterone was near the lower limit of normal, the average value of follicle-stimulating hormone was higher than normal and the testosterone/luteinizing hormone ratio was unusually low. Testis biopsy indicated that long-term gossypol treatment affected both germ cells and Sertoli cells. Leydig cells also demonstrated some damage. Gossypol acetate is, in general, considered an ideal male contraceptive because of its long-term effectiveness, reversibility, and lack of severe toxic side effects.
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PMID:Antifertility treating with long term gossypol. 1226 55

This review discusses clinical aspects and mechanism of action of various injectable steroids used for contraception. The clinical effectiveness of various injectables is presented tabularly, with the following compounds having notable failure rates: medroxyprogesterone, 400 mg, 9.5 pregnancy/100 woman years; SH 582, 200 mg, 37/100 woman years; SH 582, 2.5 mg, 30/100 woman years; oxagesterone, 50 mg, 22/100 woman years. Contraceptive efficacy of medroxyprogesterone acetate, norethindrone enanthate, and Deladroxate was confirmed. Cycle control using injectables was generally good, but oral estrogens can be used with the injectables to help cycle control if needed. Clinical side effects to pure progestogens are minimal, although headaches, dizziness, dyspepsia, or nonspecific effects have been noted. Addition of estrogen leads to breast symptoms in 9-13% of cases, and sometimes to weight gain, nausea, and vomiting. Use of injectables is particularly encouraged for postpartum women. Despite cycle irregularities associated with progestogen injectables, acceptability is good--drop-out rate is in the 25% range for the commonly used compounds. Fertility is reestablished within 5 weeks to 4 months after injections cease. Possible mechanisms of action of injectables include: inhibition of ovulation either due to inhibition of luteinizing hormone or direct effect on the ovary; effect on the endometrium; or effect on cervical mucus such that it becomes hostile to spermatozoa.
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PMID:Injectable steroids as a method of contraception. 1231 80

FDA has approved medroxyprogesterone acetate as Depo Provera Contraceptive Injection, effective for 3 months in preventing pregnancy in women. In clinical studies, the drug's failure rate was less than 1%. However, physicians must ensure that patients receive injections on schedule to prevent pregnancy. The recommended dose is 150 mg administered every 3 months by deep, intramuscular injection in the gluteal or deltoid muscle. Most women in clinical studies of Depo Provera experienced menstrual irregularities. As use continued, amenorrhea became common, reported by 57% of the women by the end of a year of treatment. Other side effects included weight gain, headache, nervousness, abdominal pain or discomfort, dizziness, and asthenia. Physicians should administer the drug only to women found not to be pregnant, because fetal exposure may lead to low birth weight and other problems. Recent data have demonstrated that longterm use may contribute to osteoporosis, and the drug's manufacturer, the Upjohn Company of Kalamazoo, Michigan, will conduct additional research to study this possible side effect. Contraindications are similar to those for other contraceptives and include undiagnosed vaginal bleeding, known or suspected malignancy of breast, thromboembolic disorders, cerebral vascular disease, and liver dysfunction. Depo Provera was developed in the 1960s and has been approved for contraception in many other countries. When FDA first reviewed data on the drug in the 1970s, animal studies raised questions about its potential to cause breast cancer. Since then, longterm controlled clinical studies in other countries have shown a risk of breast cancer comparable to oral contraceptives, and no increased risk for ovarian, liver, or cervical cancer. The studies also showed that the contraceptive injection reduced the risk of endometrial cancer. FDA approved the drug October 29, 1992.
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PMID:3-month contraceptive injection approved. 1231 15

Depot medroxyprogesterone acetate (DMPA, Depo-Provera) is used for contraception by 8-9 million women in more than 90 countries, including the US, as of January 1993. Pharmacologically active levels of DMPA persist for 3-4 months following injection. A 150 mg dose is used most often for high contraceptive efficacy every 3 months. Norethindrone enanthate (NET-EN, Noristerat) is somewhat less widely used and is not marketed in the US. Injectables act primarily by inhibiting ovulation, lowering the levels of follicle-stimulating hormone and luteinizing hormone. Approximately 50% of women using DMPA for 1 year report amenorrhea whose occurrence is less frequent with NET-EN. Menstrual changes are the most frequent causes of discontinuation of injectables. In cases of heavy bleeding it is appropriate to undergo gynecological examination to rule out unrelated conditions, such as vaginitis, cervicitis, or cervical lesions. The use of conjugated estrogen (12.5-2.5 mg daily) for 10-21 days will minimize bleeding. Some women using injectables experience headache, dizziness, bloating of the abdomen or breast, and mood changes. Long-term use of DMPA or NET-EN can often result in 1-3 kg weight gain. The WHO Collaborative Study of Neoplasia and Steroid Contraceptives was launched in 1979 to examine cancer risks with the use of DMPA in Thailand, Mexico, and Kenya. The relative risk of breast cancer was 1.21, which was statistically not significant. In women diagnosed with breast cancer under age 35, short-term exposure to DMPA was associated with a slightly increased breast cancer risk, which, however, was not associated with duration of use. DMPA dramatically lowers the risk of endometrial cancer for at least eight years following discontinuation of its use. DMPA did not alter the risk of cervical cancer. Fertility returns in 70% of former users within 12 months; it is suitable for postpartum and lactating women, and provides other noncontraceptive benefits.
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PMID:Injectable contraception: the USA perspective. 1234 20

"New Era for Injectables," a report published in the most recent issue of the Johns Hopkins University School of Hygiene and Public Health's Population Reports, notes that injectable contraceptives are among the most effective family planning methods. Most clinical trials report less than one pregnancy per 100 women during the first year of use, making injectables as effective as Norplant implants, the best copper IUDs, and voluntary sterilization. Injectables also protect women against ectopic pregnancy, help to prevent endometrial and possibly ovarian cancer, and may help women with anemia and sickle-cell disease. The major side effect of injectable use is changes in menstrual bleeding. Some women also experience weight gain, and a few report headaches, dizziness, abdominal discomfort, acne, and moodiness. The most widely-used injectable is the progestin-only DMPA (depot medroxyprogesterone acetate), known under the brand name Depo-Provera and manufactured by the Upjohn Company. Women receive an injection every 3 months. Another progestin-only injectable, NET EN (norethindrone enanthate), is taken every 2 months. Cyclofem and Mesigyna, two new monthly injectables which combine estrogen and progestin, are currently being introduced in a number of countries. Worldwide, 1.5% of all married women of reproductive age who use some form of family planning use injectables. The highest level of use among such women is in Indonesia and Thailand where 15% and 12%, respectively, use injectables. Donor agencies have been responding to increasing numbers of orders for injectables from family planning programs in developing countries, while the UN Population Fund, the largest supplier, shipped 12 million doses of injectables in 1992 and 20 million in 1994. The 1992 US Food and Drug Administration approval of DMPA has made it possible for the US Agency of International Development to respond to requests for it.
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PMID:Millions of couples to have choice of injectable contraceptive. 1234 10

In well designed studies in patients with mild to moderate hypertension, combinations of the sustained-release (SR) formulation of the nondihydropyridine calcium channel antagonist verapamil 120 to 240 mg/day and the ACE inhibitor trandolapril 0.5 to 8 mg/day were significantly more effective in reducing sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline than placebo. In most randomised studies, combinations of verapamil SR 120 to 240 mg/day and trandolapril 0.5 to 8 mg/day were significantly more effective in lowering sitting DBP and SBP than the corresponding monotherapies administered at the same dosage. Trandolapril/verapamil SR 2/180 mg/day provided significantly more effective 24-hour ambulatory blood pressure (BP) control than of the corresponding monotherapies. Moreover, trandolapril/verapamil SR reduced BP in patients inadequately controlled with either of the corresponding monotherapies. The antihypertensive efficacy of trandolapril/verapamil SR 2/180 mg/day was generally similar to that of other combinations of antihypertensive agents (metoprolol/hydrochlorothiazide, atenolol/chlorthalidone, lisinopril/hydrochlorothiazide, enalapril/hydrochlorothiazide) in patients with hypertension, including those with type 2 diabetes mellitus. Trandolapril/verapamil SR reduced BP in patients with hypertension and type 2 diabetes or primary renal disease, Black patients and elderly patients. Trandolapril/verapamil SR was more effective than the individual components administered as monotherapy in reducing proteinuria in patients with type 2 diabetes or primary renal disease. Trandolapril/verapamil SR had a neutral or beneficial effect on metabolic parameters (glucose, insulin, lipids) in patients with hypertension, including those with type 2 diabetes. Trandolapril/verapamil SR preserved left ventricular function in patients with heart failure. Fewer cardiac events occurred after therapy with trandolapril/verapamil SR than after trandolapril alone in post-myocardial infarction patients with congestive heart failure. The incidence of adverse events in recipients of trandolapril/verapamil SR was similar to that of the individual components, and that of other combination therapies. In placebo-controlled trials conducted in the US, headache, upper respiratory tract infections, cough, constipation, atrioventricular block (first degree) and dizziness were the most commonly reported adverse events in recipients of combinations of verapamil SR (120 to 240 mg/day) and trandolapril (0.5 to 8 mg/day). In conclusion, the fixed-dose combination of trandolapril/verapamil SR is an effective treatment for patients with hypertension, including those with type 2 diabetes. Trandolapril/verapamil SR tended to be more effective than monotherapy with either verapamil SR or trandolapril, and generally showed antihypertensive efficacy similar to that of other combination antihypertensive therapies. Current data support the use of trandolapril/verapamil SR as an alternative treatment when monotherapy with either agent is not effective. Data from large clinical trials currently being conducted will assist in fully defining the role of trandolapril/verapamil SR as a cardio- and renoprotective agent.
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PMID:Fixed combination trandolapril/verapamil sustained-release: a review of its use in essential hypertension. 1242 Nov 12


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