Women can take abortion pill later says FDA

The US Food and Drug Administration (FDA) has approved a label change allowing Danco’s Mifeprex (mifepristone) ‘morning after’ pill to be used up to 70 days after a woman’s last period, instead of the 49 days it previously allowed.

Information provided by Danco shows that the new label allows for a single 200mg dose, which has fewer side effects than the previous dose of three 200mg tablets.

The accompanying dose of misoprostol has increased to 800 mcg buccally, from the previous 400 mcg orally.

New labelling requires assessment 7-14 days after taking the drug, instead of a follow-up 14 days later at the same clinic, which could reduce costs for patients and providers.

The pro-abortion National Abortion Federation welcomed the news – president and CEO Vicki Saporta said the FDA’s changes reflected an evidence-based regime that was already used widely across the US since the drug was approved in 2000.

But some states, such as Ohio, North Dakota and Texas, had prohibited “off-label” use such as this.

Saporta said: “What will change is that politicians can no longer deny women access to this safe and effective method of early abortion care by insisting on an outdated regimen.”

Bloomberg noted that lawmakers in Arizona have already sought to thwart the label change by sending its governor a bill explicitly requiring the old label, which could become law this week.

Randall O’Bannon, director of education and research at the anti-abortion group, National Right to Life, said: “It is obvious that the FDA’s new protocol serves only the interests of the abortion industry by expanding their base of potential customers, increasing their profit margin, and reducing the level of staff and amount of resources they have to devote to the patient.”

Related stories:

FDA rejects call for label change for depression drug Brintellix

FDA rejects Newron’s Parkinson’s drug, better news for potential Acadia blockbuster

 

 

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.