Bravelle is a fertility medication used to induce ovulation in women. In October 2015, the drug’s manufacturer quietly issued a Bravelle recall, after quality testing revealed that certain batches of the medication did not meet potency specifications for their full 24-month shelf life.

What is Bravelle?

Bravelle (urofollitropin) is a purified form of follicle-stimulating hormone (FSH), a hormone that helps the ovaries produce eggs. The injectable medication is indicated to treat infertility in women whose own natural FSH is not sufficient. Bravelle is also is used to help the ovaries produce multiple eggs for use in “in vitro” fertilization.

Bravelle is injected under the skin or into a muscle, usually once a day or as directed by a doctor. The dosage and length of treatment are based on a patient’s specific medical condition, response to treatment, laboratory tests, and other medications they may be taking.

Bravelle Side Effects

Initially, Bravelle may cause the following side effects:

  • Headache
  • Nausea and vomiting,
  • Mild stomach/abdominal pain
  • Bloating
  • Redness/pain at the injection site
  • Breast tenderness/pain

Women undergoing treatment with Bravelle should inform their doctor if any of the above side effects persist or worsen.

Women who experience the following Bravelle side effects should tell their doctor right away:

  • Unusual bleeding from the vagina/uterus
  • Pain/redness/swelling of the calf muscles
  • Cold/numb/pale skin of the arms/legs/hands/feet
  • Swelling of ankles/hands/feet

The following complications require immediate medical attention:

  • Weakness on one side of the body
  • Slurred speech
  • Vision changes
  • Sudden severe headache
  • Chest pain
  • Shortness of breath.

Bravelle may also cause a condition known as ovarian hyperstimulation syndrome (OHSS). Patients should seek immediate medical attention if they experience:

  • Severe pain or swelling in the lower abdominal (pelvic) area
  • Severe nausea/vomiting, sudden/rapid weight gain
  • Difficult/painful breathing
  • Change in the amount of urine

Patients should also seek medical attention if they experience symptoms that could be signs of an allergic reaction, including:

  • Rash
  • Itching/swelling (especially of the face/tongue/throat)
  • Severe dizziness
  • Trouble breathing

The Bravelle Recall

In October 2016, Ferring Pharmaceuticals issued a Bravelle recall, after the company determined that several batches of the medication did not meet potency standards through their expiry period. While the recall only affected certain lots purchased between March 2014 and October 2015, Ferring decided to remove all remaining lots from the U.S. market.

The Bravelle recall encompassed more than 32,000 vials of the drug. The affected lot numbers included:

  • K11813A-1 – Exp 1/16
  • K11813A-2 – Exp 01/16
  • K11813B-1 – Exp 1/16
  • K11813C-1 – Exp 04/16
  • K13031A-1 – Exp 5/16
  • K13031B-1 – Exp 5/16
  • K13031B-2 – Exp 05/16

Because the recall involved the effectiveness of Bravelle, rather than a health risk, the U.S. Food and Drug Administration (FDA) was not directly involved in the action.

Bravelle Lawsuits

A number of Bravelle lawsuits have been filed in the U.S. and Canada since the drug was pulled from the market in October 2015. While Ferring has offered patients reimbursement for the drug itself, it does not appear that the company has  any plans to compensate women for the costs of failed IVF treatments. Read More

  1. Ferring Pharmaceuticals (2014) “Bravelle: Highlights of Prescribing Information”
  2. FDA (2015) “Enforcement Report – Week of October 21, 2015”
  3. CTV News (2016) “B.C. couple launches class-action lawsuit over ineffective fertility drug”
Last Modified: April 13, 2016

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