The use of preterm birth drugs has always been a controversial topic in the field of medicine. While these medications are known to prevent preterm labor and save babies’ lives, they can also come with serious side effects that raise concerns among healthcare professionals and patients alike. Recently, one such drug- Makena- made headlines when it was taken off the market after 12 years due to insufficient evidence of its effectiveness. In this blog post, we’ll dive into the controversy surrounding Makena and what this means for expecting mothers everywhere.
What is the drug?
The drug is called Makena, and it is a synthetic form of progesterone. It is used to help reduce the risk of preterm birth in women who have a history of delivering babies early.
Makena was approved by the FDA in 2011, but its safety has been questioned ever since. In 2015, the FDA released a statement saying that there was no evidence that Makena was any more effective than natural progesterone in preventing preterm birth.
Last year, an independent review panel concluded that Makena should be taken off the market because it is ineffective and poses a potential risk to patients. The drug’s manufacturer has appealed the decision, but as of now, Makena is no longer available for prescription.
How did it come to be used for preterm births?
Makena, a drug given to women who are at risk for preterm birth, was taken off the market last week by its manufacturer.
The drug was approved by the FDA in 2011, but has been controversial since then. Some experts say it’s ineffective and too expensive, while others say it’s a vital tool to prevent preterm births.
Now that it’s been taken off the market, what does this mean for women who are at risk for preterm birth?
Makena was originally approved by the FDA in 2011 to help reduce the risk of preterm birth in women who had already had a spontaneous preterm birth. The drug is a synthetic version of progesterone, a hormone that helps support pregnancy.
Progesterone is produced naturally by the body during pregnancy, and levels of the hormone decline when labor begins. This decline is thought to play a role in triggering preterm labor. Makena is designed to maintain higher levels of progesterone in the body, which theoretically could help prevent preterm labor from occurring.
However, there has been controversy surrounding Makena since its approval. Some experts have questioned whether the drug is effective at reducing the risk of preterm birth, and whether it’s worth its high price tag (the list price for Makena is around $30,000 for a course of treatment). Additionally, some studies have raised concerns about potential side effects of Makena, such as
Why is it controversial?
The FDA has pulled the plug on Makena, a drug given to women who are at risk for preterm birth. The decision comes after years of controversy and debate over the drug’s efficacy and safety.
Makena was first approved in 2011, but its maker, KV Pharmaceutical, immediately came under fire for pricing the drug at $1,500 per injection. Critics argued that the high cost would limit access to the potentially life-saving medication.
KV eventually lower the price of Makena, but questions about its effectiveness remained. A large study published in 2016 found that the drug did not reducing the rates of preterm birth or improve neonatal outcomes.
The FDA’s decision to take Makena off the market is based on these findings. The agency says that there is no evidence that the drug is safe or effective, and that it should not be used to treat or prevent preterm birth.
What are the side effects?
The drug is known to increase the risk of preterm labor and birth, as well as a range of other serious side effects. These include:
– Preterm labor and birth
– Increased risk of infection
– Bleeding during pregnancy
– placental abruption (when the placenta breaks away from the uterus before delivery)
– perinatal death (death of a baby around the time of delivery)
The decision to take this drug off the market was made after years of controversy and debate. Many experts feel that the risks of taking this drug outweigh any potential benefits.
What does this mean for preterm births in the future?
The drug, Makena, was taken off the market after years of controversy. The drug was used to treat preterm births, but it was found to be ineffective and potentially harmful. This means that preterm births will continue to be a problem in the future. There is no easy solution to this problem, and it is something that must be addressed by medical professionals and parents alike.
Conclusion
The controversy surrounding the preterm birth drug, Makena, is a reminder of how important it is to evaluate drugs and treatments on an ongoing basis. The news that Makena was being taken off the market after 12 years highlights the need for further research into medications like these before they are released onto the open market. We should all be aware of what’s going on in medical circles so that we can make informed decisions about our own health and safety.
