Is Clomiphene Citrate Discontinued or Shortage in 2023

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Is Clomiphene Citrate Discontinued? Women who don’t generate ova (eggs) but want to get pregnant can use clomiphene to stimulate ovulation (egg production). The drug clomiphene belongs to the group of drugs known as ovulatory stimulants. It works in the same way as estrogen, a female hormone that promotes the development and production of eggs from the ovaries.

Clomiphene is sold under the brand name Clomid. Also, the FDA has approved it in these formulations: CLOMID (clomiphene citrate, tablet; oral). The manufacturer of this drug was Sanofi-Aventis US. This medication was authorized before January 1, 1982. The above formula is no longer available. Pfizer discontinued clomiphene citrate pills in September 2022.

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s there a shortage of clomiphene?

Since many years ago, clomiphene citrate has been the most often recommended oral medication for ovulation induction. But beginning in June 2017, the clomiphene medication from EMD Serono was discontinued, according to a statement. The only option left to the medical professionals for ovarian stimulation and ovulation induction was injectable gonadotropins. This was stated by Togas Tulandi, Chief Department of Obstetrics and Gynecology and Medical Director.

A 50-mg tablet of clomiphene is provided for oral use. The first tablet is normally taken on or around the fifth day of the menstrual cycle. It is usually taken once a day for five days. Females who do not have monthly cycles can take the medication anytime.

Clomiphene should be used exactly as prescribed, and dosage adjustments should only be made with a doctor’s approval. There could be some negative side effects from clomiphene. The most typical of these symptoms are bloating and pelvic or stomach pain.

If patients develop any of the following clomiphene side effects, they should call their doctor right away. The side effects include:

  • distorted vision
  • dual perception
  • observing flashes or spots
  • abdominal pain
  • enlarged stomach
  • gaining weight
  • breathing difficulty

Taking clomiphene can cause ovarian hyperstimulation syndrome (OHSS) in certain people. This may endanger their lives too. If users experience the following OHSS signs, get in touch with the doctor immediately. These symptoms include:

  • Nausea
  • Vomiting
  • Diarrhea
  • Diarrhea
  • abdominal pain
  • enlarged stomach

The drug clomiphene may affect vision. Patients should only drive or operate heavy machinery if they are certain this medication does not cause them to develop blurred vision.

A non-steroidal oral drug called clomiphene citrate is prescribed to treat certain types of infertility. It induces ovulation in females. Clomiphene’s brand name, Clomid, has been discontinued in the US. But the generic form can still be accessible. In September 2022, Cosette purchased tablets of Clomid 50 mg. The product was first distributed in October 2022. Clomiphene citrate tablets were stopped in September 2022.

The products affected by the discontinuation are as follows:

  • Clomiphene citrate oral tablet, 50 mg, unit-dose blister pack, 10 counts, NDC 49884-0701-54, Par Pharmaceuticals
  • Clomiphene citrate oral tablet, 50 mg, unit-dose blister pack, 30 counts, NDC 49884-0701-55, Par Pharmaceuticals

There isn’t a clinically equivalent kind of Clomid in America right now.

Fertility drugs for ovulation

The female reproductive system produces a mature egg every month during ovulation. During ovulation, the pituitary gland in the brain secretes two hormones. They are follicle-stimulating hormone (FSH) and luteinizing hormone (LH). These hormones are collectively referred to as gonadotropins. The pituitary gland’s “messenger” hormone, FSH, encourages the growth of follicles in the ovaries, each containing one egg. LH is in charge of initiating the release of the egg (ovulation).

A wide range of disorders affects the body’s ability to ovulate successfully. Utilizing drugs that encourage the ovarian follicles to generate several eggs in a single cycle is one of the best strategies for overcoming this difficulty. Clomiphene citrate (Clomid or Serophene) and gonadotropins (Follistim, Menopur, Bravelle, and Gonal-F) are the two most popular reproductive drugs used to stimulate ovulation.

When clomiphene is taken, it binds to estrogen receptors in the brain and raises pituitary FSH levels. Gonadotropins are similar to the human protein hormones FSH and LH. When given by injection, it skips the pituitary gland and activates the ovaries directly.

Clomiphene Citrate uses

Generally, clomiphene is used to treat infertility in women. Men also use clomiphene to boost testosterone production. By decreasing estrogen’s attraction to the pituitary gland, clomiphene boosts the production of luteinizing hormone, follicle-stimulating hormone, and testosterone.

Oral clomiphene is a widely used drug with a good reputation for being safe, efficient, and affordable. Clomiphene treats missing or irregular menstrual cycles(ovulation induction). This is to address a condition called a luteal phase defect. This is achieved by increasing progesterone secretion during the second half of the cycle. Clomiphene may also enhance ovulation in women who are already ovulating (ovulation augmentation).

When given clomiphene, roughly 70% of anovulatory women (unable to generate an egg each month) will ovulate. Furthermore, conception rates comparable to a patient’s age should be achieved. 

To initiate menstruation and ovulation in women without a menstrual cycle, clomiphene may be given together with the drug Provera.

These treatment methods will be stopped if ovulation cannot be achieved even with a greater dose of clomiphene. In this situation, a different fertility medication (letrozole or gonadotropins) may be used to try again to stimulate ovulation.

Conclusion

If clomiphene therapy does not work for someone, they can try other fertility treatments. Other treatments for ovulation induction may be considered if 3-6 complete clomiphene cycles fail to result in a pregnancy. Gonadotropins and intrauterine insemination may be advised for older adults. Younger patients, in whom the risk of multiple pregnancies with gonadotropins and IUI is higher. The best course of action that will likely be suggested is in vitro fertilization.

Anyone who has infertility should know that they are not alone. While going through fertility treatments, get help from a therapist, a support group, and reliable friends and family. Patients don’t have to and shouldn’t accomplish this by themselves. It is better to have more assistance.

References:

  • https://www.verywellhealth.com/clomid-5116569
  • https://www.jogc.com/article/S1701-2163(17)30531-5/pdf
  • https://www.pavilioncompounding.com/clomiphene-citrate-compounded-during-drug-shortage/
  • https://www.drugs.com/drug-shortages/clomiphene-citrate-tablets-538#:~:text=Par%20 discontinued%20 clomiphene%20 citrate%20 tablets%20in%20 September%202022.
  • https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=538
  • https://www.jogc.com/article/S1701-2163(17)30531-5/fulltext
  • https://www.drugs.com/availability/generic-clomid.html
  • https://www.pacificfertilitycenter.com/treatment-care/clomiphene#:~:text=The%20two%20 most%20 common%20 fertility,Bravelle%20and%20 Gonal%2DF).
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