What is Makena: the premature birth drug hydroxyprogesterone caproate

Makena, also known as hydroxyprogesterone caproate, is a synthetic form of the hormone progesterone. It is a prescription medication used to lower the risk of preterm birth in pregnant women who have previously experienced a spontaneous preterm birth. Preterm birth refers to the delivery of a baby before 37 weeks of gestation. By reducing the risk of preterm birth, Makena can help improve the chances of a healthy pregnancy and reduce the potential complications associated with premature delivery.

Makena is administered as an intramuscular injection, usually starting between the 16th and 20th week of pregnancy and continuing until the 37th week or until the baby is born, whichever comes first. The injections are typically given once a week by a healthcare professional.

It is important to note that Makena is not intended for use in women with multiple pregnancies (e.g., twins, triplets) or other risk factors for preterm birth, aside from a prior history of spontaneous preterm birth. Pregnant women should discuss their individual risk factors and medical history with their healthcare provider to determine if Makena is an appropriate treatment option for them.

History of the drug Makena

  • 1950s: Hydroxyprogesterone caproate is first synthesized. Researchers begin studying its use in the prevention of preterm birth.
  • 1960s-2000s: Studies investigating the use of hydroxyprogesterone caproate for the prevention of preterm birth continue. The drug is available through compounding pharmacies, where it is custom-prepared according to healthcare provider prescriptions.
  • 2006: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) sponsors a clinical trial (known as the Meis trial) to evaluate the effectiveness of hydroxyprogesterone caproate in preventing recurrent preterm birth.
  • 2011: Based on the results of the Meis trial and other supporting evidence, the U.S. Food and Drug Administration (FDA) approves Makena, a branded version of hydroxyprogesterone caproate developed by KV Pharmaceutical (later known as Lumara Health), specifically for reducing the risk of preterm birth in women with a history of spontaneous preterm birth.
  • 2011: After the FDA approval, Makena initially faces controversy over its high pricing compared to the previously available compounded version of hydroxyprogesterone caproate. In response, the FDA releases a statement indicating that it will not take enforcement action against pharmacies compounding the drug, provided specific conditions are met.
  • 2014: KV Pharmaceutical, now known as Lumara Health, is acquired by AMAG Pharmaceuticals, which continues to manufacture and market Makena.
  • 2018: The FDA approves a subcutaneous auto-injector form of Makena, providing an alternative to the original intramuscular injection.
  • 2020: In October, the FDA considers withdrawing approval for Makena due to conflicting evidence from a follow-up study (the PROLONG trial) that questions the drug's effectiveness in preventing preterm birth. However, the FDA's decision is postponed, allowing Makena to remain on the market pending further review.
    • Oct. 2020: Covis Group agreed to acquire biopharmaceutical company AMAG Pharmaceuticals for a total consideration of approximately $647 million, or $13.75 per share, including debt obligations.
  • 2021: Makena is still available for use, but healthcare providers and patients must consider the latest evidence and individual circumstances when deciding whether to use the drug for preterm birth prevention.

The 2023 FDA market removal of Makena

On Thursday, April 6, 2023, the Food and Drug Administration (FDA) demanded the immediate removal of a drug designed to prevent premature births from the market. This drug has remained accessible for years, despite evidence suggesting it is ineffective for pregnant women.

Swiss pharmaceutical company Covis Pharma had made multiple attempts to keep Makena available in the U.S. while conducting further research. Makena was the sole medication approved in the U.S. to mitigate the risk of early births for women with a history of preterm deliveries.

Recently, under pressure from the FDA, Covis agreed to a "winding down" period lasting several months, allowing women currently using the drug to finish their treatment. However, the FDA declined this proposal and announced on Thursday that the decision against Makena and its generic counterparts should be implemented right away.

The agency stated, "Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce."

Side effects of Makena

As with any medication, Makena may have side effects, which can include injection site reactions, itching, and swelling. More serious side effects are less common but may include blood clots, allergic reactions, or jaundice. Pregnant women should consult their healthcare provider if they experience any concerning side effects while receiving Makena.

Here is a list of potential side effects associated with the drug Makena (hydroxyprogesterone caproate). It's important to note that not all patients experience these side effects, and some may be more common or severe than others. If you have concerns about side effects, consult your healthcare provider.

  • Injection site reactions: Pain, swelling, itching, or bruising at the site of the injection are common side effects. These reactions are usually mild and temporary.
  • Hives or rash: Some patients may experience hives or a rash as an allergic reaction to the medication.
  • Nausea: Makena may cause mild nausea in some individuals.
  • Diarrhea: The drug may cause diarrhea in some patients, which is typically mild and manageable.
  • Itching: Generalized itching, apart from the injection site, may occur in some cases.
  • Swelling: Makena may cause swelling, particularly in the hands, feet, or lower legs.
  • Fluid retention: Some patients may experience fluid retention while taking Makena, which can contribute to swelling.
  • Fatigue: The drug may cause tiredness or fatigue in some individuals.
  • Blood clots: Although rare, Makena may increase the risk of blood clots. If you experience symptoms like sudden shortness of breath, chest pain, or leg swelling, contact your healthcare provider immediately.
  • Allergic reactions: Severe allergic reactions to Makena are rare but can be life-threatening. Symptoms may include difficulty breathing, rapid heartbeat, chest pain, or swelling of the face, lips, or tongue. Seek immediate medical attention if you experience any of these symptoms.

What is the hormone Progesterone

Progesterone is a steroid hormone that plays a crucial role in the female reproductive system. It is primarily produced by the ovaries, but during pregnancy, the placenta also produces progesterone. This hormone is essential for various reproductive functions, including:

  • Menstrual cycle regulation: Progesterone levels rise during the second half of the menstrual cycle (the luteal phase) after ovulation. It prepares the endometrium, the inner lining of the uterus, for potential implantation of a fertilized egg. If pregnancy does not occur, progesterone levels drop, leading to the shedding of the endometrium and the onset of menstruation.
  • Pregnancy maintenance: If a fertilized egg implants in the endometrium, progesterone helps maintain the pregnancy by keeping the endometrium thick and providing a supportive environment for the developing embryo. It also suppresses the immune system to prevent the mother's body from rejecting the developing fetus and helps prevent contractions of the uterus that could lead to premature labor.
  • Breast development and milk production: Progesterone, along with other hormones like estrogen and prolactin, contributes to breast development during puberty and pregnancy. It also plays a role in preparing the breasts for milk production during pregnancy, although the hormone's levels decrease after giving birth to allow lactation to occur.

Why would an expecting mother require a synthetic form of progesterone

A pregnant woman may require a synthetic form of progesterone for various reasons, some of which include:

  • History of preterm birth: As mentioned earlier, Makena (hydroxyprogesterone caproate) is used to lower the risk of preterm birth in pregnant women with a previous spontaneous preterm birth. This synthetic progesterone helps maintain adequate hormone levels in the body, which may contribute to a more stable uterine environment and reduce the risk of early labor.
  • Progesterone deficiency: Some women may have a progesterone deficiency, which can increase the risk of miscarriage or preterm birth. In such cases, supplemental progesterone in the form of synthetic hormones may be prescribed to help support the pregnancy.
  • Assisted reproductive technology (ART): Women undergoing fertility treatments, such as in vitro fertilization (IVF), may be given synthetic progesterone to help prepare the uterus for embryo implantation and maintain the pregnancy after embryo transfer. The hormone supplementation supports the endometrium, providing a favorable environment for the developing embryo.
  • Luteal phase support: Some women may experience a luteal phase defect, which is characterized by inadequate progesterone production following ovulation. This can lead to problems with embryo implantation and early pregnancy loss. In these cases, synthetic progesterone can be used to supplement the body's natural hormone production and improve the chances of a successful pregnancy.

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