The European manufacturer of NorLevo, a product that is identical to the emergency contraceptive Plan B One-Step, will be introducing a new warning on its packaging that the product may not work in women weighing more than approximately 176 pounds, according to a new report from Mother Jones.
Let me repeat: This pill is exactly the same as the emergency contraceptive pills sold in the United States. It just happens to be manufactured in Europe by a company called HRA Pharma.
After research from the University of Edinburgh revealed that emergency contraceptive pills containing a compound called levonorgestrel may fail in women with higher body mass indexes (BMIs), HRA Pharma conducted a review of the available data. They then requested permission from the European Union to update the drug’s product information, Mother Jones reported.
And by the way, this data was first published in 2011.
Any health care professional can tell you that any hormone or any medication – whether an antibiotic or painkiller – gets diluted when a person’s body weight is higher. The prevention of a pregnancy is a serious matter, and now we have research to suggest emergency contraceptives may not work if you’re overweight – a problem that millions of Americans deal with.
So what’s going on now? In Europe, the manufacturer plans to issue new warnings so that patients who are overweight – especially those weighing more than 176 pounds – will know that the drug may not be effective for them, and therefore, a pregnancy may not be prevented. Furthermore, the company will warn that the pill may begin to lose effectiveness in women who weigh more than approximately 165 pounds.
In the United States, both pharmaceutical companies and the FDA are going to have a lot of explaining to do. Was this information buried in the files of the FDA? Was this information buried in the due-diligence safety studies that pharmaceutical companies are required to do? And how are they going to handle updating women with this information?
Teva Pharmaceuticals, the manufacturer for Plan B One-Step, did not immediately respond to FoxNews.com’s request for comment. However, a spokesperson for the FDA said in a statement:
"The FDA is currently reviewing the available and related scientific information on this issue, including the publication upon which the NorLevo labeling change was based. The agency will then determine what, if any, labeling changes to approved emergency contraceptives are warranted.
"As background, the original approval of Plan B for use in the U.S. did not include an assessment specific to weight. NorLevo is not approved under this brand name in the U.S."
One of the things that I’ve argued so strongly in the past is that hormonal therapy is very complex. In my opinion, putting these types of medications in the hands of teenagers is highly inappropriate, because a young teenage girl may not have the maturity to realize if she is experiencing an adverse side effect of the drug.
Let me tell you, that there are a lot of 18-year-olds and 21-year-olds in this country who weigh more than 176 pounds. It seems that if we want to make these types of emergency contraceptives available to them, they will need to be counseled by medical professionals to make sure they receive the correct dosages.
That counseling needs to come from the men and women working in health care. It can’t come from Washington. The FDA needs to come to their senses and re-examine the issues with Plan B One-Step, and similar drugs, more carefully.
This astonishing revelation clearly demonstrates that when the government pushes an agenda out of political desire – such as their desire to make a product like Plan B accessible over-the-counter – mistakes can happen.
Dr. Manny Alvarez serves as Fox News Channel's senior managing health editor. He also serves as chairman of the department of obstetrics/gynecology and reproductive science at Hackensack University Medical Center in New Jersey. For more information on Dr. Manny's work, visit AskDrManny.com.