French-based HRA Pharma, manufacturer of the emergency contraceptive drug Norlevo, is set to issue warnings on its drug which states that the drug will not prevent pregnancy in women over a certain weight limit.
The reason this is concerning is because Norlevo’s pill is identical to the version used in the United States.
This emergency contraceptive pill, better known as the “morning-after pill,” is commonly purchased up to 5 days after a woman has had unprotected sex, and is taken to inhibit pregnancy.
The new warning states that the drug is “not effective” for women over 80 kilograms (176 pounds) and is “less effective” in women 75 kilograms (166 pounds) or more. These warnings will be in place within the next 7 months.
Here’s something to consider: we have already mentioned that the emergency contraceptives used in the United States are almost identical in chemical structure and dosages found in Norlevo. So shouldn’t that mean that the emergency contraceptives women use here in the U.S. will be found to be “not effective” in women over 176 pounds?
The average weight of American women ages 20-29 is 161 pounds. The average weight of American women ages 30-39 is 169 pounds, which is right around the weight limit for Norlevo’s effectiveness range. So women who rely on this pill should be concerned.
Take that statistic, coupled with the statistic from the U.S. Center for Disease Control which states that one in nine women between the ages of 15 and 44 have used emergency contraceptives between 2006 and 2010, and we should realize just how much this drug is used.
An alternative to these emergency contraceptives, which is recommended by doctors, is to use a copper-T intrauterine device (IUD) for emergency contraception. According to Princeton and the Association of Reproductive Health Professionals’ website, the device is 99% effective as emergency contraception.
Erin Gainer, CEO of HRA Pharma, gave a statement to the Huffington Post in regards to this issue. It said: “the effect of a woman’s weight on levonorgestrel efficacy was first identified in 2011 during the development of an alternative emergency contraceptive product in the context of a clinical trial. As a result, HRA Pharma has performed further analyses in 2012, which enabled it to put together a safety variation which was presented to some European regulatory authorities at the start of 2013. By sharing the date in this manner it demonstrates a clear obligation by the company to be transparent with the healthcare community and provide regulators with the most up to date information to inform women.”
It will be interesting to see whether the United States emergency contraceptive manufacturers adopt these labels. It would be hard to justify how a European pill can have differing side effects than its American counterparts, even though they share the same chemical makeup and the same dosage.
What do you think about this news? Will you still use emergency contraceptives if you are above the “less effective” weight limits?
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