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The Clomid Drug Lawsuit

Clomiphene Citrate, marketed under the brand names Clomid and Serophene, helps stimulate egg production for women who have faced fertility issues. Unfortunately, there is some evidence that Clomid may be associated with an increased risk of birth defects, including skull and heart defects, if taken by women who are pregnant.

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What is Clomid?

Clomiphene, marketed under the brand name Clomid, is an orally administered, nonsteroidal which increases ovulation or the production of eggs in women with fertility issues. Clomid can be taken by tablet one time per mouth at a specific time in the menstrual cycle.

What is Clomid used for?

Clomid can be used to assist with menstrual abnormalities, fibrocystic breasts, and persistent breast milk generation. Clomid has also been used to treat secondary male hypogondadism and has been used as an alternative to testosterone replacement. The FDA has not given its approval for treatment for hypogondadism so this is considered an “off-label” prescription. All information regarding the use of this medication for off-label uses should be discussed with your doctor. As with all medication, there are side-effects and risks, especially for nursing mothers or for the unborn. This medication may cause serious side-effects for certain patients, even if used correctly. Common side-effects can include upset stomach, breast discomfort, headache, abnormal vaginal bleeding, vomiting, flushing, blurred vision, double vision, stomach pain, weight gain, shortness of breath, and visual spots.

  • Fibrocystic breasts
  • Persistent milk generation
  • Menstrual abnormalities
  • Male infertility
  • Increased ovulation

Clomid Usage and Statistics

Clomid, which is manufactured by Sanofi-Avantis, has been used by women in the United States since its approval in 1967. Clomid helps stimulate ovulation in women struggling with fertility issues. Lawsuits have been filed against Sanofi-Avantis which claim that although Clomid may help increase fertility, it may also remain in a woman’s body following pregnancy and cause risks to the unborn baby. The Federal Drug Administration currently classifies Clomid as a Category X drug, which means it may cause birth defects in the unborn. Do not take Clomid if you are pregnant or nursing.

How Clomid Works

Millions of women throughout the United States suffer with infertility issues. Thankfully, modern medications and new technology have given these women a chance to have children. One popular medication is clomiphene, which is marketed under the brand names Clomid and Serophene. Clomiphene works by stimulating the release of certain hormones, specifically the follicle-stimulating hormone (FSH). The drug is consumed early in the menstrual cycle and is especially helpful for women who have an irregular menstrual cycle or who fail to ovulate entirely. Clomiphene is only used if the woman is determined to have stable and normal pituitary gland function and estrogen levels.

Side Effects of Clomid

  • Although the benefits of most medications outweigh the negative side-effects, it is important to understand the risks of taking medication. Talk to your doctor before taking any medication and notify them if you experience any serious issues. Clomid can have serious side-effects such as the following:
  • Pain and swelling
  • Ovarian hyperstimulation syndrome
  • Severe GI symptoms
  • Pleural Effusions
  • Shortness of breath
  • Abdominal swelling
  • Seizures
  • Stroke
  • Chest pain
  • Vision issues

Clomid Medical Studies

Clinical studies have been completed for Clomid. Under these studies 7,578 patients with fertility impediments were evaluated. During the studies pregnancy occurred in approximately 30% of these patients. Fetal abnormalities were reported for less than 1% of the babies. Abnormalities, according to information provided by the FDA, included “congenital heart lesions, Down syndrome, club foot, congenital gut lesions, hypospadias, microcephaly, harelip and cleft palate, congenital hip, hemangioma, undescended testicles, polydactyly, conjoined twins and teratomatous malformation, patent ductus arteriosus, amaurosis, arteriovenous fistula, inguinal hernia, umbilical hernia, syndactyly, pectus excavatum, myopathy, dermoid cyst of scalp, omphalocele, spina bifida occulta, ichthyosis, and persistent lingual frenulum.” At the completion of these studies researchers concluded the number of deformities and issues were “within the range of that reported for the general population.” The FDA does acknowledge, however, that there have been reports of fetal and neonatal anomalies since Clomid has been approved including “abnormal bone development, skeletal malformations of the skull, skeletal malformations of the face, nasal passages and jaw, malformations of the hands, clubfoot, malformations of the spine and joints, cardiac abnormalities, septal heart defects, muscular ventricular septal defects, coarctation of the aorta, chromosomal disorders such as Downs syndrome, ear abnormalities and deafness, gastrointestinal tract abnormalities including cleft lip and palate, imperforate anus,diaphragmatic hernia, and omphalocele.”

Clomid Black Box Warnings

  • Users with liver disease, mental depression, or thrombophlebitis should notify their doctor before taking Clomid. This medication may cause dizziness, light headedness, and vision issues and should be used carefully if you are driving or operating heavy machinery. Patients may also experience an allergic reaction to this medication which is indicated by swelling in the face, tongue, or lips. Other side-effects can include pelvic pain, flushing, nausea, diarrhea, blurred vision, and abnormal uterine bleeding. Do not use this product if you have any of the following:
  • Hypersensitivity
  • Liver or kidney failure
  • Metrorrhagia of unknown etiology
  • Ovarian failure together with hyperprolactinaemia
  • Pregnancy
  • Ovarian cysts
  • Neoplasms of genital organs
  • Tumor or hypofunction of the hypophysis
  • Endometriosis

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