Supply shortage of breast cancer drug tamoxifen patients in fear for their health

Breast cancer patients are confused: There are supply bottlenecks for the drug Tamoxifen, which accompanies tens of thousands of patients for years.

The drug tamoxifen is designed to prevent breast cancer from recurring. But it is currently in very short supply, there are massive supply bottlenecks. How should affected women deal with this, who are afraid that without the drug the cancer will return?? Gynecologists and oncologists say don't panic. There are alternatives.

Breast cancer patients are severely distressed: There are massive supply shortages of the drug tamoxifen, which accompanies tens of thousands for years. "Our mailbox is full of concerned inquiries ", Andrea Hahne from the BRCA network, which advises women with breast cancer. "They are worried that the cancer will come back if therapy is not continued." Gynecologists and oncologists vehemently demand that supplies come soon, but they also say: There is no reason to panic.

Examination of a breast for breast cancer by mammography.

(Photo: picture alliance/dpa)

Tamoxifen is a so-called selective estrogen receptor modulator. These are drugs that mediate their effect through the receptors for the hormone estrogen. The active ingredient docks with the tumor cell. Blocks the influence of estrogens on tumor cell growth. Thus it ensures that tumor cells do not continue to grow. Tamoxifen is used in follow-up care – the aim is to reduce the likelihood of a relapse in the long term. "It is an indispensable part of the therapy of patients with hormone receptor-positive breast cancer", says a statement with which five professional societies have jointly reacted to the situation. Sufferers typically take 20 milligrams daily -. Although five to ten years. In the years 2019 to 2021, 27 to 28 million daily doses were prescribed according to the GKV drug index. Based on this, estimates that 120.000 to 130.000 female patients – but also some male patients – could be affected by the tamoxifen shortage.

"The causes of this lack of care are manifold", says the Federal Institute for Drugs and Medical Devices (BfArM): There is no single cause, but "interactions of different effects". The professional societies see a possible explanation, among other things, in an "increase in prescriptions since the first quarter of 2020 in connection with the lockdown measures due to the Covid 19 pandemic". It is conceivable that women may have stockpiled at the beginning of the Corona pandemic.

Measures to counter supply bottlenecks

The BfArM has already been monitoring the development since January. Because the market share of tamoxifen is high, it belongs to the "supply-relevant active substances". The Advisory Board for Supply Shortages at the BfArM has initiated measures to mitigate the supply bottleneck:

The companies are to examine whether quotas "can be made available for the German market without creating a shortage of supply in other countries". Doctors should "not ie prescriptions for individual stockpiling" in the coming months. Patients should switch to other package sizes, for example, take two 10-milligram tablets instead of the usual 20-milligram tablet.

The question remains what those affected should do if the supply comes to a complete standstill. "An alternative equivalent drug therapy is not available", it says in the official announcement of the Federal Ministry of Health in the Federal gazette on the 18. February. "But there are alternatives", says Michael Untch, head of gynecology at the Helios Klinikum Berlin-Buch: "No one need be afraid. So-called aromatase inhibitors in particular are available as an alternative. Hormone-inhibiting injections available. These are drugs that block estrogen production. The problem: "Replacing tamoxifen with other forms of endocrine therapy is fraught with a higher rate of side effects.", warn the professional societies. Bone problems ranging from joint pain to osteoporosis are mentioned above all. The side effects can be managed, says Untch. "The most important message is that an alternative therapy must be found." Interrupting therapy could increase relapse rate.

Whether or not it makes sense to switch drugs in the short term to bridge the bottleneck depends on the individual case, says Bernhard Wormann of the Clinic for Hematology, Oncology and Tumor Immunology at Berlin's Charite University Hospital. A short-term interruption of a few days would also be medically possible. However, it emphasizes, "Interrupting therapy is not a solution to this supply crisis." It is not yet clear how long the shortage will last. "The complex and time-consuming manufacturing process for drugs containing tamoxifen requires a lead time of several weeks, explains the BfArM. Supply could be "around the end of April 2022" are expected. The first imported batches could possibly arrive as early as next week, Wormann says.

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