Levonorgestrel Adverse Reactions
- abdominal pain
- acne vulgaris
- alopecia
- amenorrhea
- anemia
- anorexia
- anxiety
- appetite stimulation
- back pain
- biliary obstruction
- breakthrough bleeding
- breast discharge
- cervicitis
- cholestasis
- depression
- dizziness
- dysmenorrhea
- dyspareunia
- ectopic pregnancy
- edema
- elevated hepatic enzymes
- emotional lability
- exfoliative dermatitis
- fluid retention
- headache
- hepatitis
- hepatoma
- hirsutism
- hyperglycemia
- hypertension
- infection
- injection site reaction
- jaundice
- leukorrhea
- libido decrease
- mastalgia
- menorrhagia
- menstrual irregularity
- myocardial infarction
- nausea/vomiting
- paresthesias
- phlebitis
- pruritus
- pseudotumor cerebri
- retinal thrombosis
- stroke
- thromboembolism
- uterine pain
- uterine rupture
- vaginitis
- visual impairment
- weight gain
Levonorgestrel Adverse Reactions
For acute oral emergency contraception, Plan-B™:
Adverse reactions associated with levonorgestrel used orally as an oral contraceptive are usually minimal. Nausea/vomiting occurs in roughly 23%/5.6% of patients respectively versus 51%/19% of those who take estrogen-progestin oral emergency contraceptives (e.g., the Yuzpe methods). Other common side effects include abdominal pain (18%), fatigue (17%), headache (17%), menstrual changes [heavier (13%) or lighter bleeding (13%)], dizziness (11%) and breast tenderness (11%). A pregnancy test is indicated if menstrual bleeding does not occur within 21 days of taking the emergency regimen. Serious side effects are not common.
For the Mirena® IUD system:
Syncope, bradycardia, or other neurovascular episodes may occur during insertion or removal of the Mirena® IUD, especially in patients predisposed to these conditions or with cervical stenosis. These side effects are due to the device procedures involved and not due to the drug itself. If decreased pulse, diaphoresis, or pallor are observed, the patient should remain supine until these signs have disappeared.
Because levonorgestrel in the Mirena® IUD system is released just within the uterus, very few systemic side effects are expected to occur. The most serious adverse events include device expulsion; ectopic pregnancy (rate of 1 per 1000 users per year); pelvic inflammatory disease or other infection; sepsis (e.g., toxic shock syndrome or group A streptococcal sepsis); and risks of embedment of the device or perforation of the cervix or uterus (uterine rupture) by the IUD device. Most serious events are infrequent in nature with proper patient selection and education.
Other adverse events reported in 5% of Mirena® IUD users include: abdominal pain; abnormal pap smear; acne or skin disorder not specified; back pain; depression; dysmenorrhea; headache; hypertension; mastalgia; nausea; nervousness; leukorrhea; libido decrease; sinusitis; upper respiratory infection; vaginitis; and weight gain. Other reported adverse reactions in <= 3% of patients included: failed insertion; anemia; cervicitis; dyspareunia; eczema; hair loss (alopecia); migraine; vomiting. The Mirena® IUD should be removed for any of the following medical reasons: menorrhagia and/or metrorrhagia that produces anemia; AIDS or other sexually transmitted disease; pelvic infection; endometritis; genital actinomycosis; intractable pelvic or uterine pain or severe dyspareunia; pregnancy; endometrial or cervical malignancy; or uterine or cervical perforation. Consider removal if migraine headaches or exceptionally severe headaches occur, especially if migraine is focal in nature with asymmetrical vision impairment or other symptoms that suggest transient cerebral ischemia. Marked hypertension, the appearance of jaundice, or severe arterial disease such as stroke or myocardial infarction are other reasons to consider IUD discontinuation.
For the Norplant® implant system and routine systemic use of levonorgestrel in general:
NOTE: The Norplant® drug product is discontinued in the US.
Adverse reactions that have been reported frequently, particularly during the early months of implantable levonorgestrel therapy, include breakthrough bleeding, spotting, menstrual irregularity, scanty bleeding, and amenorrhea. Other reported adverse reactions during levonorgestrel therapy include abdominal pain; acne vulgaris or exfoliative dermatitis (e.g., eczema); anorexia; breast discharge; cervicitis; dizziness; hirsutism; leukorrhea; nausea/vomiting; anorexia, vaginitis; and appetite stimulation or weight gain.
As with all hormonal contraceptives, headache patterns may change during levonorgestrel use. Consider removal if migraine headaches or exceptionally severe headaches occur, especially if migraine is focal in nature with asymmetrical visual impairment or other symptoms that suggest transient cerebral ischemia.
Levonorgestrel sub-dermal implants can cause a type of injection site reaction. Pain or pruritus at the implant site have been reported in 5 - 6% of patients. In addition, there is growing concern regarding the removal of the six silicone rods that release levonorgestrel. Removal of the implants can require surgery and may be painful or result in scarring.
Fluid retention and/or edema may occur in patients receiving levonorgestrel. Patients with heart failure and/or renal disease may experience an exacerbation of their condition.
Patients receiving levonorgestrel or other hormonal contraceptives can experience emotional lability. This adverse effect may be manifest as mental depression, anxiety or nervousness, frustration, anger, or other emotional outbursts.
Thromboembolism or thrombus formation has been associated with high doses of progestins. Other rare adverse reactions that may occur during progestin therapy may include retinal thrombosis, elevated blood pressure, hepatoma, hepatitis (and elevated hepatic enzymes), biliary obstruction or cholestasis, and hyperglycemia. Marked hypertension, the appearance of jaundice, or severe arterial disease such as stroke or myocardial infarction are reasons to consider levonorgestrel discontinuation.
Levonorgestrel sub-dermal implants have been possibly associated with the development of pseudotumor cerebri (benign intracranial hypertension) in less than 1% of patients.
A surgical incision is required to insert levonorgestrel subdermal implants, and complications related to insertion such as pain, edema, and bruising may occur. Other effects related to implant insertion such as infection (including cellulitis and abscess formation), blistering, ulcerations, sloughing, excessive scarring, phlebitis, and hyperpigmentation at the insertion site are possible. In addition, arm pain, numbness, and tingling (i.e., paresthesias) following insertion and removal have been reported. Nerve injury is possible and is most commonly associated with deep placement and removal. Expulsion of the implants is possible and occurs more often when placement of the implants is shallow or too close to the incision, or when infection is present. The implants can become displaced; while most reports involve minor changes in the positioning, significant displacement (a few to several inches) can occur (< 1%). Some of these reports have been associated with pain and difficult removal. Removal is also a surgical procedure and may take longer, be more difficult, and/or cause more pain than insertion and may be associated with difficulty locating the implants. Removal difficulties affecting subjects (including multiple incisions, capsule fragments remaining, pain, multiple office visits, deep placement, or lengthy removal procedure) have been reported with a frequency of 6.2%, which is based on 849 removals occurring through 5 years of use.
[ Last revised: 7/25/2005 4:54:00 PM ]
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