UPDATED: Merck runs into manufacturing glitch for ovulation drug

Merck & Co. headquarters
Merck & Co. headquarters

Merck & Co. ($MRK) is facing another supply interruption for its ovulation-stimulating hormone Follistim, and like the supply lapse from several years ago, Merck has little to say.

A notice on the American Society of Health-System Pharmacists (ASHP) website indicates the drugmaker said in mid-May that all dose forms of its Follistim AQ Cartridges were on backorder but didn’t give a reason.

Merck spokeswoman Megan Wilkinson said in an email this week, “I can confirm that we have informed customers that we are experiencing a supply shortage and we are working to re-supply FOLLISTIM as quickly as possible and expect that supply shortage will be resolved by July 1.” She said the drug is manufactured in the U.S. but did not say what led to the interruption. 

Used primarily to help women with ovulation difficulties to get pregnant, the injected medication contains follicle-stimulating hormone (FSH), which helps healthy ovaries to produce eggs. Merck is the sole producer of Follistim, but other injectable FSH drugs work similarly.

Dr. Eric Levens, a physician partner at Shady Grove Fertility in the Washington, D.C., area, said the recall was problematic because Follistim is one of only three urofollitropin injection drugs in the marketplace to begin with. Another of those, Bravelle, was recalled by Ferring Pharmaceutical last fall because of potency concerns. While patients can be switched to another product if it is available, that situation is not ideal.

“The Follistim recall creates more of a shortage and leaves you with one option,” Dr. Levens said.  “Everyone has their favorite and patients often feel beholden to what they have done before. It can create a lot of stress for patients.”

Merck ran into a supply interruption with Follistim in 2012 which information indicates ran until 2013. In that situation, Merck also did not disclose the reason for the supply problems for Follistim AQ, a drug that generated sales of $383 million for Merck in 2015, down from $412 million in 2014 and $481 million in 2013.

Of course, drug shortages tied to manufacturing interruptions are a fact of life in healthcare these days, with dozens of drugs in short supply at any one time. Currently, about 150 are listed by the University of Utah Drug Information Service. Recently, a supply problem at a Pfizer ($PFE) plant led to a shortage of a particular antibiotic that is the only drug approved for treating syphilis in pregnant women.

In that case, a Pfizer spokeswoman said it recognized the importance of Bicillin to patients and had taken “remedial action to minimize the duration of the supply shortage,” including allocating shipments to help avoid a stockout. It said it expects to be able to resupply the antibiotic in July.

- here’s the ASHP notice

Related Article: 
Pfizer drug shortage causes issues for syphilis treatment

Editor's note: This story was updated with comments from Dr. Eric Levens. 

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