There’s an ongoing nationwide shortage of an injectable estrogen used by menopausal and transgender women, and the federal government just announced it still won’t be back in stock this month, as was previously expected.
Doctors began running out of high doses of Delestrogen in 2014, but there were hopes that a generic version of estradiol valerate would be on pharmacists’ shelves by October. In an update last week, however, the U.S. Food and Drug Administration said that option was still unavailable and is now slated for November, due to a shortage of an inactive ingredient.
“The FDA recognizes this is an important drug and is working with the drug manufacturers so that the drug may return to the market as quickly as possible, while ensuring safety for patients,” the federal agency said in an emailed statement on Tuesday.
Estrogen injections are sold in three doses: 10mg, 20mg, and 40mg. The hormone is naturally present in women’s bodies but declines during menopause, and for transgender women the hormone helps promote the development of female characteristics when administered over a period of about 1 to 2 years.
The lower doses are primarily given to women in menopause, while the preferred amount for transgender women is 40mg. The 40mg version stocks emptied out around March of 2014, but transgender women still had the option of taking two 20mg injections. But this summer, those stocks also dwindled. Doctors are hesitant to administer four of the 10mg injections, and other estrogen options like the patch are not preferred, due to cost.
Several factors are at play in the shortage. Delestrogen-maker Par Pharmaceuticals said it could no longer obtain an important ingredient after the supplying company stopped producing it. The company has since gotten another source for the ingredient and is manufacturing the product again, but the FDA has to sign off on the change before the drug can get back on the market, BuzzFeed News reported.
While the public waits for Delestrogen to get re-approved, there’s been optimism about the generic option, known as estradiol valerate injection and produced by pharmaceutical company Perrigo. The 20mg and 40mg generic versions were tentatively set to be released this month before the FDA announced the latest delay. A shortage of an inactive ingredient is the reason for the availability issues, according to the FDA’s latest drug shortage update.
Hormone therapy is critical for transgender individuals and losing access to estrogen injections could create a serious health threat to transgender women, according to the Human Rights Campaign.
“The injectable form is preferred by many transgender women and health professionals are concerned that these women may turn to unregulated sources such as the street or black-market online pharmacies that ship drugs from other countries,” the campaign wrote in a statement last month.