"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
The following adverse reactions, reported during menotropins therapy, are listed in decreasing order of potential severity:
- Pulmonary and vascular complications (see WARNINGS)
- Ovarian Hyperstimulation Syndrome (see WARNINGS)
- Adnexal torsion (as a complication of ovarian enlargement)
- Mild to moderate ovarian enlargement
- Ovarian cysts
- Abdominal pain
- Sensitivity to menotropins (Febrile reactions suggestive of allergic response have been reported following the administration of menotropins. Reports of flu-like symptoms including fever, chills, musculoskeletal aches, joint pains, nausea, headaches, and malaise have also been reported).
- Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal cramps, bloating)
- Pain, rash, swelling and/or irritation at the site of injection
- Body rashes
- Dizziness, tachycardia, dyspnea, tachypnea
The following medical events have been reported subsequent to pregnancies resulting from menotropins therapy:
- Ectopic pregnancy
- Congenital abnormalities
With menotropin therapy congenital abnormalities have been reported. One infant was shown to have multiple congenital anomalies consisting of aplasia of the sigmoid colon, cecovesicle fistula, bifid scrotum, meningocele, bilateral internal tibial torsion, and right metatarsus adductus. Other reported anomalies include imperforate anus, congenital heart lesions, supernumerary digits, hypospadias, extrophy of the bladder, Down's syndrome and hydrocephalus. The incidence of congenital abnormalities does not exceed that found in the general population.
There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.
Adverse events occurring in ≥ 1% of patients exposed to Repronex® (menotropins for injection) IM or Repronex® (menotropins for injection) SC are described in Table 4.
Table 4: Patients with Adverse Events ≥ 1%
|Adverse Events||n (%)||n (%)|
|INJECTION SITE AEs|
|Injection Site Edema||1 (1.0)||8 (8.3)*|
|Injection Site Reaction||2 (2.0)||8 (8.3)*|
|OHSS||2 (2.0)||5 (5.2)|
|Vaginal Hemorrhage||8 (7.9)||3 (3.1)|
|Ovarian Disease||3 (3.0)||8 (8.3)|
|Ectopic Pregnancy||1 (1.0)||1 (1.0)|
|Pelvic Pain||3 (3.0)||1 (1.0)|
|Breast Tenderness||2 (2.0)||2 (2.1)|
|Nausea||4 (4.0)||7 (7.3)|
|Vomiting||0 (0)||3 (3.1)|
|Diarrhea||0 (0)||2 (2.1)|
|Abdominal Cramping||7(6.9)||5 (5.2)|
|Abdominal Pain||5 (5.0)||7 (7.3)|
|Enlarged Abdomen||6 (6.0)||2 (2.1)|
|OTHER BODY SYSTEM AEs|
|Headache||6 (6.0)||5 (5.2)|
|Infection||1 (1.0)||0 (0)|
|Dyspnea||1 (1.0)||2 (2.1)|
|* Fisher's Exact/Chi-Squared Tests- significant for Repronex® SC vs.Repronex® IM.|
Drug Abuse And Dependence
There have been no reports of abuse or dependence with menotropins.
Read the Repronex (menotropins for injection) Side Effects Center for a complete guide to possible side effects
No information provided.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/9/2008
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