Yasmin Adverse Reactions
- abdominal pain
- acne vulgaris
- alopecia
- amenorrhea
- anorexia
- anxiety
- appetite stimulation
- azotemia
- breakthrough bleeding
- breast discharge
- breast enlargement
- candidiasis
- cervical dysplasia
- cholecystitis
- cholelithiasis
- cholestasis
- depression
- diplopia
- edema
- elevated hepatic enzymes
- erythema nodosum
- fluid retention
- galactorrhea
- gingivitis
- headache
- hepatitis
- hepatoma
- hypertension
- jaundice
- keratoconus
- libido decrease
- maculopapular rash
- mastalgia
- melasma
- menstrual irregularity
- migraine
- myocardial infarction
- nausea/vomiting
- optic neuritis
- pancreatitis
- peliosis hepatis
- photosensitivity
- pulmonary embolism
- retinal thrombosis
- secondary malignancy
- stroke
- thromboembolism
- thrombosis
- urticaria
- vaginal bleeding
- vaginitis
- weight gain
Yasmin (Drospirenone; Ethinyl Estradiol) Adverse Reactions
Females who participated in clinical studies tolerated drospirenone; ethinyl estradiol well; only 6% discontinued use due to side effects. In addition, blood pressure, lipids, glucose tolerance, electrolytes, and hematology values among healthy Yasmin® users remained within normal range. The most frequently reported adverse events in one study of drospirenone; ethinyl estradiol included headache (10.7%) and mastalgia (9.2%). The following adverse reactions are generally common during the initiation of an OC regimen and often subside after the first few months of routine OC use. These require medical attention only if prolonged or bothersome: abdominal discomfort or cramps, appetite stimulation, mild nausea/vomiting, fluid retention or edema with weight gain, azotemia, breast enlargement, and fatigue. In general, drospirenone; ethinyl estradiol exhibits a low incidence of these side effects. In some cases, switching to an oral contraceptive combination of a different dose strength or estrogen to progestin ratio or combination can resolve troublesome effects that continue.
The antimineralocorticoid actions of 3 mg of drospirenone are comparable to 25 mg of spironolactone and may cause hyperkalemia in predisposed patients. In clinical trials of otherwise healthy users of drospirenone; ethinyl estradiol, the serum lipid, glucose, and electrolyte values remained within normal range. Patients likely to be at risk for increased potassium levels from drospirenone include those on medications that may raise serum potassium. In renally impaired patients taking potassium-sparing medications concurrently with drospirenone in clinical trials, mean serum potassium levels increased by up to 0.33 mEq/l, but hyperkalemia was not observed. It is essential to avoid this OC combination in patients with adrenal insufficiency, hepatic disease, or renal disease.
The following additional adverse event information relates to the use of combination hormonal contraceptives as a class; in some cases the relation of listed side effects to drospirenone; ethinyl estradiol use specifically is not known:
Changes in vaginal bleeding patterns (e.g., menstrual irregularity) often occur after initiation of hormonal contraceptive therapy. Breakthrough bleeding and spotting are common during the first 3 months of administration of most OCs. These changes usually subside and are replaced by a more predictable menstrual bleeding pattern with appropriate continuation of dosing. Amenorrhea is occasionally reported in combination OC users.
The relationship of migraine headache and the administration of hormonal contraceptives is not clearly defined. A number of changes can occur when a woman initiates hormonal contraceptive therapy and include 1) migraines can appear for the first time, 2) a change in frequency, severity and duration of headaches may be seen, or 3) an improvement or decrease in the occurrence of migraine or other headaches may occur. When initiating therapy an individual’s headache pattern should be observed and if headaches worsen or if focal neurologic findings are present, consider discontinuing therapy.
Combined hormonal contraceptive use has traditionally been associated with various thromboembolic disorders. The risk for the development of deep venous thrombosis and/or pulmonary embolism is approximately 3—6 times greater in OC users than in nonusers. In several studies, the risk of thromboembolism was reported to be higher in smokers compared with nonsmokers. Both hormone amount and hormone type may be important factors. Estrogens decrease levels of antithrombin-III and increase the production of blood clotting factors VII, VIII, IX and X; risks increase with ethinyl estradiol doses > 50 mcg/day. The additional effects of progestin in combination with the estrogen may also influence embolic risk. Regarding stroke and OC use, risk may be related to the amount of estrogen as well as the type of progestin, although this issue is controversial. Early epidemiological studies showed an increased risk for stroke, however these studies assessed OCs containing more than 50 mcg of ethinyl estradiol. Recent literature has shown that the use of the lower dose (i.e., <= 35 mcg ethinyl estradiol) oral contraceptive combinations available today do not increase a healthy woman’s risk of heart attack or stroke. Smoking remains the largest risk factor for embolic events while on hormonal contraceptives.
In clinical trials, blood pressure values among healthy drospirenone; ethinyl estradiol users remained within normal range. In general, hypertension may occur within a few months of initiating hormonal contraceptive therapy and the prevalence increases with duration of use and patient age. Close monitoring of blood pressures is recommended for patients at risk for hypertension; blood pressures usually return to normal after discontinuation of therapy.
Vaginal discharge or vaginal irritation due to candidiasis or vaginitis can occur during therapy with hormonal contraceptive agents.
Mood or personality changes occur commonly in women taking hormonal contraceptive agents. These changes include emotional lability mental depression, anxiety, libido decrease, frustration, anger, or other emotional outbursts. In some cases, women discontinue the OC due to mood changes. In general, drospirenone; ethinyl estradiol does not appear to aggravate luteal phase emotional lability (such as PMS).
Ocular disorders can occur during therapy with hormonal contraceptive agents. These can include optic neuritis, diplopia, loss of vision, or retinal thrombosis. Estrogens can cause keratoconus. A conical cornea develops from increased curvature of the cornea, caused by thinning of the stroma. Patients with contact lenses may develop intolerance to their lenses. Any change in vision or visual acuity should be examined by an ophthalmologist. Hormonal contraceptive agents should be discontinued in patients developing any unexplained visual disturbance.
In a recent pooled-data analysis from 2 large United States sites, women between the ages of 18—44 years old who had no prior incidence of coronary heart disease (CHD) or cerebrovascular disease prior to their MI event were studied for relative risk related to low-dose oral contraceptives. After adjustment for ethnicity and major established risk factors for CHD, there was no evidence of increased risk of myocardial infarction associated with OC use. Most other recent studies have concurred. One major exception was the WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. This international multicenter case-control study found a 5-fold increased risk of MI associated with current OC use. The authors, however, concluded that the increased risk might reflect more frequent use of OCs internationally in populations at higher risk, such as smokers and those with pre-existing cardiovascular risk factors. No increased risk of MI was noted in women who were non-smokers and in whom blood pressure was screened prior to OC use. Smoking is a well known additive risk to hormonal contraceptive therapy, increasing the relative risk of MI by five-fold. There is a 10—12 fold increase in risk of MI in patients who use hormonal contraceptive therapy and smoke compared to females who do not smoke or use OCs. Thus one would expect a higher incidence of MI in any woman taking oral contraceptives whom has known risk factors.
Estrogens can cause a variety of dermatological reactions. Melasma, in the form of tan or brown patches, may develop on the forehead, cheeks, temples, and upper lip. These patches may persist after the drug is discontinued. Photosensitivity can be experienced with combined contraceptive use and protective clothing and sunscreens should be employed when exposed to sunlight or UV light. Other dermatologic reactions are infrequent and include maculopapular rash, urticaria, erythema nodosum, alopecia, or hirsutism. Other erythematous eruptions may occur. Although combined hormonal contraceptives have been used to treat acne vulgaris, in some cases they may induce or aggravate an existing acne vulgaris. Combined hormonal contraceptives have not been shown to increase the incidence of skin cancer of any type, including melanoma.
Some women taking combination hormonal contraceptives notice tenderness, swelling, or minor bleeding of their gums, which may lead to gingivitis. Proper attention to oral care and regular dental visits are recommended.
Abdominal pain occurring with the use of combined hormonal contraceptives can indicate cholelithiasis, cholecystitis, or cholestasis. Abdominal pain and anorexia occurring with the use of combined hormonal contraceptives can indicate hepatitis (and elevated hepatic enzymes), hepatoma (benign liver tumor), peliosis hepatis, or pancreatitis. Hormonal contraceptive agents should be discontinued in any patient developing severe abdominal pain and/or jaundice until the patient has been evaluated. Most case-control studies have shown a relationship between oral contraceptives and the incidence of benign hepatoma and hepatocellular cancer. Risk may increase with increasing duration of combined hormonal contraceptive use.
The relationship between hormonal contraceptive use and certain types of secondary malignancy is controversial. The information from any study must be balanced with the knowledge that virtually all epidemiologic data on cancer risks and combined oral contraceptive use pertain to women younger than 60 years of age because oral contraceptives (OCs) were first available for general use in the early 1960’s. The World Health Organization (WHO), after a thorough review of published data, has classified combined estrogen-progestin oral contraceptives as carcinogenic in the development of breast, cervical, and hepatocellular cancer. However, there continues to be some controversy regarding the use of OCs and the risk of developing breast cancer as several large, well designed observational studies have provided conflicting data. It should be noted that the increased risk of breast cancer is small, and is only relevant in current or recent users (i.e., within the last 10 years).The breast cancer studies noted pertain to the use of OCs for the purpose of contraception, and may not apply to the use of OCs as hormone-replacement therapy alternatives in the perimenopausal woman (i.e., use of hormones later in life). The issue of prescribing hormonal contraceptives to women with a family history of breast cancer remains controversial. All women should be advised to report breast enlargement, lumps or unusual breast discharge (e.g., galactorrhea) to their health care professionals. If breast cancer is suspected in a woman who is taking hormonal contraceptives, the contraceptive should be discontinued. An association between oral contraceptive use and cervical cancer has been demonstrated. However, studies of cervical dysplasia and carcinoma in situ have been difficult to interpret due to the presence of confounding factors, such as difference in sexual practices and the presence of human papillomavirus (HPV). There has been suggestion that OCs may in some way act as a promoter for HPV-induced cancer, but this is speculative. In most studies, risks of cervical cancer begin to increase after 2 years of use and become clinically significant after 5 years of use. A meta-analysis of 14 studies in over 3800 women showed a summary relative risk of invasive cervical cancer of 1.37 after 4 years of use; relative risk increased to 1.6 after 8 years of use. Because a potential for cervical dysplasia may exist, it is prudent to regularly evaluate patients on OCs via cervical cytology screening on an annual basis. Most case-control studies have shown a relationship between oral contraceptives and the incidence of benign hepatoma and hepatocellular cancer. Risk may increase with increasing duration of combined hormonal contraceptive use. It must be noted that many studies of hepatocellular cancer and OCs have not controlled for the presence of the hepatitis B virus. Infection with hepatitis B has a strong correlation with the pathogenesis of hepatic carcinoma, and exclusion of this important variable in the OC studies makes it difficult to interpret true risk. Only one case of death related to liver cancer has been reported in the past 20 years of studies of OCs. Given the overall rarity of hepatocellular cancer in any population, the risk to women taking OCs is probably negligible. However, because liver tumors may spontaneously rupture and produce life-threatening hemorrhage, it is important to be aware of the possibility that tumors could occur.
A meta-analysis of 10 studies indicated significant trends in decreasing endometrial and ovarian carcinoma risks with increased duration of combined hormonal contraceptive use. Risk of endometrial or ovarian cancers may be reduced by up to 60% with 4 or more years of use. Current evidence suggests OCs do not protect against hereditary forms of ovarian cancer (e.g., women who carry BRCA1 or BRCA2 gene alterations).
[ Last revised: 8/5/2005 11:14:00 PM ]
Related entries
Monthly Archives
Syndicate
Allergies
