Mother Jones
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Monday morning, Mother Jones reported that the European manufacturer of an emergency contraceptive pill identical to Plan B, also known as the morning-after pill, will warn women that the drug is completely ineffective in women weighing more than 176 pounds, and begins to lose effectiveness in women weighing more than 165 pounds. HRA Pharma, which makes the European drug, Norlevo, asked European regulators for permission to change the drug’s labeling after reviewing its own clinical data and scientific research from 2011 which showed emergency contraceptives are prone to fail in women with higher body mass indexes.
Now the Food and Drug Administration has responded to this story, telling Mother Jones that FDA officials are weighing whether pharmaceutical companies that sell similar emergency contraceptive pills in the US must change their labeling. Many popular morning-after pills sold in the US—including one-pill emergency contraceptives Plan B One-Step, Next Choice One Dose, and My Way, as well as a number of generic two-pill emergency contraceptives—are chemically identical to Norlevo, which also uses the chemical compound levonorgestrel to prevent pregnancy after sex.
“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,” FDA spokeswoman Erica Jefferson writes in an email. “The agency will then determine what, if any, labeling changes to approved emergency contraceptives are warranted.”
Jefferson declined to say when the FDA began its review. If FDA officials feel they have sufficient data to justify a change to product information, the FDA can order companies to update their labels. Jefferson adds that US drug companies have a legal obligation to alert the FDA if new information makes their existing labeling inaccurate.
See original:
FDA Reviewing Evidence That Morning-After Pill Doesn’t Work in Women Weighing Over 176 Pounds
