Testosterone shortage worsens
Delays turn to discontinuations as users urged to seek alternatives
A Quebec drug manufacturer’s announcement that it will cut production of certain drugs means trans men may face new challenges in getting their hands on injectable testosterone.
Sandoz Canada said Feb 19 it was indefinitely suspending production of injectable medicines.
Xtra reported in December last year that there was a manufacturing delay, the second such delay in 2011.
According to an American Society of Health System Pharmacists bulletin published Feb 9, Sandoz, part of the Novartis group, discontinued production of intramuscular injection Testosterone Cypionate in September of last year.
The bulletin also reported that these delays and discontinuations are due to a US Food and Drug Administration crackdown, as Novartis is not meeting current "good manufacturing practice" standards at three of its North American facilities.
A response from Sandoz Canada states that “in light of the November 2011 FDA warning letter, Sandoz Canada has further intensified its ongoing efforts to ensure high quality standards across its manufacturing operations.”
The warning reveals that Novartis failed to submit reports, including those regarding bacterial contamination. More concerning, the letter states that Novartis “has not cleaned and maintained equipment at appropriate intervals to prevent contamination that would alter the safety, identity, strength or quality of the drug product.” Despite the FDA concerns, no recalls of products have been made.
The Sandoz response states that the company will temporarily suspend or discontinue the production of certain products at its Boucherville, Quebec, site, although which drugs is yet to be determined.
And although the response claims that most of the drugs being delayed or discontinued have alternatives in the marketplace, other manufacturers like Paddock, Teva and Watson have also delayed production, with only Paddock citing raw material shortage.
While many trans men are significantly affected by these shortages, Sandoz's response states the company needs to “prioritize production of most medically necessary products, and focus on the supply of critical medicines to the Canadian market.”