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Pre-Term Birth Drug Sparks Disagreement

Makena is a prescription drug that is described as having the ability to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The status of the drug has been uncertain since October when an expert panel convened by the Food and Drug Administration (FDA) reviewed the accumulated evidence and concluded that Makena is not effective in preventing preterm birth.

Last fall, an FDA panel reviewed the studies conducted on the effectiveness of Makena. The panel concluded that the drug is not effective in preventing preterm birth. The panel voted that the FDA withdraw its approval of the drug and remove it from the market. However, this decision has become controversial with many physicians taking issue with the vote.

Preterm birth is the leading cause of infant mortality and disability in the United States. Makena is currently the only prescription drug available to prevent preterm birth. Many doctors are concerned about losing the ability to prescribe the drug. This has led what is being classified as a “fierce debate within the healthcare community.”

Two clinical studies of Makena have demonstrated different results: an older trial of American women at high risk of having a pre-term delivery showed the drug’s active ingredient seemed to be effective. More recently, a larger trial of lower-risk, international patients conducted by the drug’s manufacturer suggested that the ingredient did not work. Minor side effects of the drug include mental/mood changes (including depression), abdominal pain, vomiting, and vaginal bleeding. Serious side effects include blood clots and a very serious allergic reaction.

While Makena remains approved and available for purchase (and many doctors are lobbying to keep it that way), insurers are under no obligation to continue to cover the drug, and it seems as though the companies may indeed decline to provide coverage. A spokesperson for America’s Health Insurance Plans (AHIP), claimed AHIP is convinced by the larger, more recent trial concerning the drug, stating, “Now it is clear it is not effective.”

If the FDA pulls approval for the name-brand drug, all generic versions will be pulled as well. Many doctors passionately believe that the main ingredient is effective and should be prescribed. Dr. George Saade, the director of maternal-fetal medicine and chief of obstetrics at the University of Texas Medical Branch at Galveston, argues that cutting off all access to the active ingredient would be “a big disaster,” especially for women in disadvantaged communities who are at a higher risk of preterm birth.

Defective Medicine and Device Representation

The FDA maintains rigorous procedures for approval of prescription drugs and medical devices. However, the history of healthcare in the United States contains a multitude of examples of both devices and drugs that were approved for the market but later found to pose serious health risks, undocumented complications, and more. If you or a loved one have been injured (or you think you might have been injured) due to a defective drug or medical device, the road to recovery may be long and costly. Let our experienced and aggressive medical malpractice attorneys fight for the compensation you need to move forward. Contact our firm for a review of your case today.

About the Author

Briggs Bedigian
Briggs Bedigian

H. Briggs Bedigian (“Briggs”) is a founding partner of Gilman & Bedigian, LLC.  Prior to forming Gilman & Bedigian, LLC, Briggs was a partner at Wais, Vogelstein and Bedigian, LLC, where he was the head of the firm’s litigation practice.  Briggs’ legal practice is focused on representing clients involved in medical malpractice and catastrophic personal injury cases. 


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