It doesn’t look good folks. Our neighbor to the north, Canada, has been experiencing testosterone shortages frequently- and constantly since early 2012.
Many pharmacies in the United States are having difficulties filling prescriptions for testosterone cypionate, mine most recently suggested swapping the 100mg/mL 10mL bottle for a 10 x 100mg/mL 1mL bottle. Oy vey. (I’m sweating out the major inconvenience of cost, etc, of this option- but that’s not the point of this post) I’ll be asking my pharmacy to check supply of the 200mg/mL as well in the morning and will report back.
The cause of these shortages is mostly due to manufacturers having issues meeting the general standards for contamination set out by the FDA to protect us. By all means, I’m not against the FDA- I appreciate that they enforce regulations that ensure chemical purity. This is why I don’t purchase essence of rhino horn or any other bullshit off the internet, because I care about what goes in my body.
The FDA does monitor drug shortages in the United States- but at the time of writing, does not have information on the testosterone shortage.
From the FDA:
Q. What can FDA do to address drug shortages?
A: FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage.
For manufacturing/quality problems, FDA works with the firm to address the issues. Problems may involve very low risk (e.g. wrong expiration date on package) to high risk (particulate in product or sterility issues). Regulatory discretion may be employed to address shortages to mitigate any significant risk to patients.
FDA also works with other firms making the drugs that are in shortage to help them ramp up production if they are willing to do so. Often they need new production lines approved or need new raw material sources approved to help increase supplies. FDA can and does expedite review of these to help resolve shortages of medically necessary drugs. FDA can’t require the other firms to increase production.
When a shortage occurs and a firm has inventory that is close to expiry or already expired, if the company has data to support extension of the expiration dating for that inventory, FDA is able to review this and approve the extended dating to help increase supplies until new production is available.
When the US manufacturers are not able to resolve a shortage immediately and the shortage involves a critical drug needed for US patients, FDA searches for overseas companies that are willing and able to import the drug during the shortage. When a firm is located that is willing and able to import, FDA has utilized regulatory enforcement discretion for temporary importation to meet critical patient needs during the shortage. FDA evaluates the overseas drug to ensure that it is of adequate quality and that the drug does not pose significant risks for US patients. The information about the imported drug, and how patients can access supplies is posted on the FDA Drug Shortage website along with the Dear Healthcare Professional letter from the company that is importing the drug. FDA cannot always find a firm willing and able to import a drug during a shortage, however it is something we explore when there is a critical shortage and US patient needs are not being met.
FDA works to find ways to mitigate drugs shortages; however, there are a number of factors that can cause or contribute to drugs shortages that are outside of the control of FDA.
If you have a moment- email the FDA and request that they start monitoring this shortage (and help push manufacturers back to producing quality products). They can me reached at firstname.lastname@example.org.
Information from the American Society of Health-System Pharmacists, continually updated:
I’ve heard back from a number of entities, rather quickly.
First off, props to my pharmacy (Walgreens) for presenting me with options. Option #1, keep 100mg/mL concentration and purchase 10mL vial for ~$125 because of name brand. Option #2, move to more available 200mg/mL concentration and have insurance cover 3 x 1mL vials – “3 month supply”. I find the 1mL vials to be totally assinine and I deplore trying to precisely inject 0.25mL from a 3mL syringe, so I chose option #1. Completely privileged choice I’m able to make based on my employment- and a consideration I made due to my current health insurance plan being a high deductible with HSA plan. Hello tax-free $$. The pharmacist I spoke to today stated that the generic manufacturer (Sandoz) has discontinued the 100mg/mL concentration, hence the brand name being the only one available.
Which brings me to the 2nd communication. Sandoz was nice enough to email me back. I asked: “I see that you have discontinued the 200mg/mL concentration of this medication, do you have plans to increase production or even continue the 100mg/mL concentration?” A customer relationship associate responded “We have not discontinued making the product at this time, however the product is temporarily unavailable with no eta. Thank you.” I’m not sure there’s a difference between discontinued and “unavailable with no eta”.
Last but not least, the FDA. “Thank you for your email message. We are doing everything within FDA’s regulatory authority to ensure that the products listed in your email below continue to be available for patients. The main reason for this shortage is the discontinuation of production by the manufacturing company. … It appears the 10 ml vial is available from West Ward and Paddock.”
There are a number of options for testosterone delivery. You can be less picky than me and accept the 200mg/mL concentration (if available in your area). You may have luck getting your insurance company to cover the brand names at generic prices due to the unavailability of the generic. Compounded gels are also an option, as theevolutiononman reminded us in the comments section. For myself, I choose to never use a topical hormonal treatment due to my female partner.