Shortage of injected hormone falling hard on transgender women


A shortage of an injected estrogen drug in the U.S. is falling particularly hard on transgender women who need the drug for their transition.

The FDA Drug Shortages website lists both Delestrogen, Par Pharmaceuticals’ branded version of injected estradiol valerate, and a generic version from Perrigo ($PRGO) in short supply.

Perrigo indicates it is facing a shortage of an inactive ingredient used in the product. Par gives no reason for its shortage on the FDA site. But the company told the website Out that it had to switch API suppliers after its original source quit making the product. It is awaiting FDA approval of its new supplier.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

This has become very disruptive to transgender women, Dr. Asa Radix of Callen-Lorde, an LGBT health clinic in Manhattan’s Chelsea neighborhood, explained to the Guardian. There are alternative patches and pills but it creates problems for those women who have become accustomed to taking the injections every couple of weeks.

“Some of these women have been on their formula for a very long time,” Dr. Radix told the newspaper. “Imagine all of a sudden you’re told you can’t get the medication you’re been using maybe all of their lives. So it’s not just a matter of, does the alternative perform the same?”

Women taking ovulation drugs to get pregnant have recently faced similar issues because of a shortage.

The FDA is working with Par and Perrigo and talking with other drug producers to help restore supplies of the hormone. “The FDA recognizes this is an important drug, and will do whatever we can to help return the drug to the market for patients as quickly as possible,” FDA spokeswoman Andrea Fischer told the newspaper.

- see the FDA shortage listing here 
- read the Out story 
- more from the Guardian

Related Articles: 
Merck runs into manufacturing glitch for ovulation drug 
FDA blesses Baxter saline plant in Spain to produce for U.S. 
To avoid shortages, FDA allows imports from 8 drug plants banned for quality shortfalls

Suggested Articles

Neopharma, which has been buying and building plants for several years, is buying a sterile injectables plant and assets in Japan from India’s Lupin. 

Already knocked by the FDA four times this year, Dr. Reddy’s now has a fifth Form 483 to dwell on. This time it’s at a plant with a history of faults.

In a warning letter, the FDA details how a Chinese OTC drugmaker handed over documents faked just for the agency's inspection—and admitted it.