Transgender and menopausal women continue to suffer from a nationwide shortage of injectible estrogen, which began in 2014 when high doses of Delestrogen began to dwindle.
Transgender women require higher doses and when the 40 mg supply began to run thin, many switched to two 20 mg doses. Before long those were harder to come by as well, and most doctors were hesitant to administer four 10 mg doses.
While pills and patches are available, this option is less attractive, as many transgender women report that they aren’t as effective. The patch is also cost prohibitive, and the pill has to be taken daily and can negatively affect the liver.
Delestrogen-maker Par Pharmaceuticals said it lost its supplier for a main ingredient, and while the company has since gotten another source for it manufacturing the product again, the Food and Drug Administration has to sign off on the change before it can return to market, BuzzFeed News reported.
“They have batches manufactured (10 mg, 20 mg and 40 mg) but cannot distribute until they receive FDA approval. Once that happens, they can begin to ship immediately,” said Heather Zoumas Lubeski, a spokesperson for Par Pharmaceuticals.
“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 assuring safety for patients,” Andrea Fischer, a spokeswoman for the agency, told BuzzFeed.
The FDA had hoped the product might return in October, but they announced a delay, saying it would instead not be available until November.
It is a situation that is leaving many transgender women feeling vulnerable. With discriminatory laws like HB2 and the blowback from nationwide efforts to push for rights, including the U.S. Department of Justice suing North Carolina and the Obama administration issuing a directive for public schools to honor students’ gender identities, another cause for anxiety is particularly taxing.
“At Callen-Lorde, it’s just under 900 patients who are affected by this,” Anthony Vavasis, director of medicine at Callen-Lorde, told Out. “If you can imagine for those 900 people, if you’re told a medication that is a life-saving intervention — and experience the pill as a second-tier option — is no longer available, how would you feel?
“We’re worried about safety implications. If you look at the history of trans medicine, hormones were readily available on the street, but you never knew what you were getting,” Vavasis adds. “Patients would report how they felt on [street] injections and it was very suspicious that it may not have been what they thought it was. We are really concerned at Callen-Lorde that patients, in the short term, out of desperation, may go back to try to find injections that they believe to be the same thing they received here and, by using those injections, would be putting themselves at risk. The trans community has faced so much marginalization, historically, that we don’t want this to become another way that happens.”
“The drive and desire to be authentic, to live in the correct body, it’s so strong,” Gina Bingham, a transgender woman, told BuzzFeed. “Something like this can throw people to a bad place.”
If injectible estrogen can indeed return to market, it will at least be one concern taken off the plate of the transgender community.