Day 31 of Our 31 Day Series of How Medicine Got it Wrong

Breaking News: Makena Recall - The Dangers of a Premature Birth Drug

Makena was recalled TODAY!

Makena is a synthetic form of the hormone progesterone, which is used to reduce the risk of preterm birth in women who have had a previous preterm birth. However, the FDA has found that Makena does not significantly reduce the risk of preterm birth, and has potential safety risks.

Makena was previously approved by the FDA in 2011, based on a clinical trial that showed a reduction in preterm birth in women who had previously given birth prematurely. However, the FDA required a follow-up study to confirm the drug's effectiveness. This study did not find a significant difference in preterm birth rates between women who received Makena and those who did not. As a result, the FDA has decided to withdraw approval for Makena.

In addition to its lack of effectiveness, Makena has also been associated with potential safety risks. Some of the reported side effects of Makena include pain, swelling, or warmth at the injection site, hives, difficulty breathing, swelling of the face, lips, tongue, or throat, chest pain, coughing up blood, vision changes, severe headache, confusion, slurred speech, sudden numbness or weakness on one side of the body, rapid weight gain, or jaundice.

The recall of Makena has highlighted the importance of careful evaluation of the safety and effectiveness of medications. While Makena was initially approved based on a clinical trial, it is important to continue monitoring the safety and effectiveness of drugs to ensure that they provide the intended benefits without causing harm.

Women who have been taking Makena should talk to their healthcare provider about alternative treatments. There are other treatments available to reduce the risk of preterm birth, such as cervical cerclage or the use of vaginal progesterone. It is important for women to discuss their options with their healthcare provider, as preterm birth can have serious health consequences for both the mother and baby.

It is important to note that Makena's recall has not affected the availability of other forms of progesterone, which are commonly used in fertility treatments and to support pregnancy. It is also important to discuss any concerns about medications with a healthcare provider before starting or stopping any treatment.

In conclusion, Makena's recall by the FDA has raised concerns about its safety and effectiveness. Women who have been taking Makena should talk to their healthcare provider about alternative treatments, and it is important for all patients to discuss any concerns about medications with their healthcare provider. Careful evaluation and monitoring of the safety and effectiveness of medications is crucial to ensure that they provide the intended benefits without causing harm.

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References:

1. "FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena." U.S. Food and Drug Administration, 2023, https://www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena.

2. "Only Drug That Prevents Preterm Births to Be Pulled from US Market." Bloomberg, 2023, https://www.bloomberg.com/news/articles/2023-03-08/only-drug-that-prevents-preterm-births-to-be-pulled-from-us-market.

3. "Makena, the Only FDA-Approved Treatment for Reducing the Risk of Preterm Birth." Makena, 2023, https://makena.com/reducing-preterm-birth-risk-with-makena/.

4. "Makena Side Effects Center." RxList, 2023, https://www.rxlist.com/makena-side-effects-drug-center.htm.

5. "FDA forces Makena premature birth drug off the market." USA Today, 2023, https://www.usatoday.com/story/news/health/2023/04/06/fda-forces-makena-premature-birth-drug-market/11614142002/.

6. "Makena, a drug meant to prevent preterm births, has been pulled from the market by the FDA." The Philadelphia Inquirer, 2023, https://www.inquirer.com/health/fda-makena-preterm-birth-drug-20230406.html.

7. "FDA Withdraws Approval of Drug Meant to Prevent Preterm Births." The Free Lance-Star, 2023, https://fredericksburg.com/lifestyles/health-med-fit/fda-withdraws-approval-of-drug-meant-to-prevent-preterm-births/article_525f14e4-9b96-5da1-b52d-d4d09923a915.html.