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Plan B Morning-After Pill Isn’t Effective For Many American Women

Submitted by on November 26, 2013 – 9:58 amNo Comment

A manufacturer of a European emergency contraception pill, one identical to US-branded Plan B, has added a warning to its packaging that the medication is ineffective for women weighing over 176lbs. US manufacturers have not announced any similar changes to packaging and labeling, despite the fact that this news would affect American women even more.

Molly Redden at Mother Jones reported this week that HRA Pharma, the French manufacturer of the drug Norlevo, will change its packaging to reflect that the drug loses effectiveness for women weighing more than 165lbs, and is completely ineffective for women weighing more than 176lbs. The change comes after Scottish researchers looked into randomized trials of women on birth control to see if any were at higher risk of still becoming pregnant. They found that this affected women with higher Body Mass Indexes (BMIs). It seems like it’s still unknown why this is the case, but an HRA Pharma spokesperson told Redden that increasing dosage levels was “not proven to be a solution.”

HRA Pharma applied to the European Union to change their packaging, and received approval.

Norlevo is the brand name for levonorgestrel, and is identical to several drugs in the US, including Plan B One Step, which is produced by Gavis. Plan B is the only emergency contraception available over-the-counter to women of all ages.

This issue is even more pressing for women in America, where 35% of adults are obese. According to the latest data from the CDC, the mean weight for an American woman over the age of 20 is 166lbs- within the range of decreased effectiveness for the emergency contraception.

In the black community, the news is even worse. The mean weight for a black woman over the age of 20 is almost 188lbs, well over the point for complete ineffectiveness.

However, reportedly, no US manufacturer has contacted the FDA to change its packaging or labeling of the drug. And due to FDA guidelines, generic drug makers are not allowed to change their packaging before the primary drug maker does.


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