Nifedipine shortages continue in wake of Adalat discontinuation
The discontinuation of immediate-release (IR) Adalat capsules and shortages of some other nifedipine products has led to supply issues in parts of the UK, C+D has learned.
The 5mg and 10mg Adalat capsules were the only form of IR nifedipine available, as well as the only licensed treatment for Raynaud’s syndrome, until both strengths were discontinued by manufacturer Bayer in February and March respectively.
Commenting on the discontinuation in June, the NHS Specialist Pharmacy Service (SPS) advised that patients with Raynuad’s syndrome on Adalat IR capsules could be switched to a similar dose of a modified-release (MR) nifedipine preparation.
Bayer discontinued its own MR nifedipine products – sold as Adalat Retard – last year, while it expects its three strengths of Adalat LA prolonged-release tablets to be out of stock until 2021.
The DH told C+D that another supplier is in the process of launching a replacement IR preparation, which it expects to be available by early September.
In the meantime, other brands of MR nifedipine are available – such as Chiesi’s Adipine, UCB’s Coracten, Dexcel’s Nifedipress and Genus’s Tensipine – although the SPS warned in June that there had been “intermittent supply issues with some of these products”.
The organisation said at the time that these issues “are now resolving” and it expected stock to return to normal levels by mid-July. But some manufacturers have told C+D that local supply issues are ongoing.
“A long-term problem”
Chiesi reported in May that its Adipine 10mg and 20mg MR tablets were experiencing a “bulk supply issue with raw ingredients and an increase in demand” following the discontinuation of Adalat.
There is “no further supply date available” for these strengths, the manufacturer told C+D yesterday (August 12). “We anticipate this to be a long-term problem.”
Chiesi’s Adipine XL prolonged-release 30mg and 60mg tablets are still in stock, it pointed out.
Updates from other manufacturers
Both 10mg and 20mg strengths of Tensipine MR are out of stock until further notice, said Genus, while Zentiva said Valni XL prolonged-release tablets are temporarily out of stock while its supplies are moved to a new distributor.
Dexcel told C+D that both the 10mg and 20mg strengths of its Nifedipress MR tablets are in stock. The manufacturer has been in contact with the DH about “ongoing supply issues” for similar products and has tried to “support with additional product availability where possible”.
UCB told C+D that it has stock of its 10mg and 20mg Coracten slow-release capsules, while it is “largely out of stock” of its Coracten XL 30mg capsules – although it has a limited emergency supply available – and there is “mixed” supply of Coracten 60mg capsules across the country.
Advanz told C+D that an increase in demand had led to “some shortages” of its Adanif XL and Fortipine LA MR tablets, but it “expects the situation to improve as stocks increase”.
C+D also attempted to contact Morningside for an update on the availability of its Nidef PR tablets, but had not received a response at time of going to press.
Helen Lewis, a locum pharmacist based in Wales, told C+D last week that the shortages have been a “nightmare” and described trying to source the correct brand as “like trying to win the lottery”.
“Unless [the prescriber] has written the script generically, you’re not going to have the one you want when a patient comes in,” she said.
“Patients and pharmacists are confused,” she added. “It’s frustrating not having answers for people.”
Ms Lewis is particularly concerned for patients with Raynaud’s syndrome who had previously been on the now-discontinued IR Adalat, she said.
“When doctors are switching [patients] to other preparations of nifedipine, they are effectively prescribing off-licence.”
Read C+D's free CPD module explaining how to advise patients with Raynaud’s syndrome about the current nifedipine shortages and the considerations when switching them to a MR preparation.
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