Merck, J&J and Allergan Seek Changes on FDA Draft Guidance on Hormonal Contraceptive Labeling
Posted 07 March 2018 | By
Three drugmakers – Merck, J&J and Allergan – are seeking tweaks to the US Food and Drug Administration’s (FDA) draft guidance on hormonal contraceptive labeling, according to comments submitted this week.
The draft guidance, released in January
, sought to align recommendations with requirements from the agency's 2006 physician labeling rule and 2014 pregnancy and lactation labeling rule.
But both Merck and J&J noted that the draft does not include a warning on the risk of concomitant hepatitis C treatment.
Merck noted that such a “contraindication was recently added to some contraceptive labels due to a contraindication in the Viekirax label. We would appreciate clarification on whether this information should be included in the document.”
Janssen suggested that FDA add to the draft: “During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT [alanine aminotransferase] elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as CHCs [combined hormonal contraceptives]. Discontinue [Tradename] prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4)]. [Tradename] can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.”
Merck also noted that the draft says it does not apply to patient labeling and Merck suggested that either this draft or a separate document should address such labeling.
And Allergan questioned FDA’s broadening of its labeling guidance to include that “studies suggest an increased risk of developing gallbladder disease among CHC users. Use of CHCs may also worsen existing gallbladder disease.”
“Allergan is unclear about any new evidence or study data which indicate an increased risk of developing gallbladder disease among patients prescribed CHCs,” the comment said.