Teva Recalls Anagrelide Capsules Due to Dissolution Failure and Faces Potential Shortages of 24 Injectable Drugs Amid Irvine Plant Shutdown

Compiled by Fan DongEast

Recently, during routine stability testing of its thrombocytosis drug Anagrelide, Teva discovered that the drug had poor dissolution. Due to the failure of the dissolution test, patients taking the drug would require more time for it to dissolve. As a result, Teva is recalling a batch of 0.5 mg Anagrelide capsules in the U.S. market, while other batches are currently unaffected.

Teva warned in a notification on the U.S. FDA website that taking Anagrelide capsules which do not dissolve properly may suppress or negate the drug's effect of reducing platelets. Poorly dissolved capsules can hinder the efficacy of the medication, potentially rendering the treatment ineffective. For patients with severe blood disorders, consuming these problematic Anagrelide capsules could have fatal consequences.

As of this Monday, Teva stated that it has not received any quality complaints or side effect reports regarding the suspected batches. Between July 30 and September 2, 2020, the company distributed a total of 4,224 bottles in the U.S. market, with the affected batch of Anagrelide capsules set to expire this month.

Previously, Anagrelide capsules received approval from the U.S. FDA for the treatment of thrombocytosis secondary to myeloproliferative neoplasms. Specifically, patients with thrombocytosis produce an excessive number of platelets, leading to abnormal bleeding and clotting, which in turn places them at risk of heart attack or stroke.

Teva explained that Anagrelide capsules, which aim to reduce platelet counts, may lead to slower speed and extent of drug release if there are issues with poor dissolution. This could result in a reduced availability of Anagrelide in the patient's body, making it difficult for patients to avoid clotting, bleeding, or both clotting and bleeding events.

Notably, this is not the first time Teva has appeared in the U.S. FDA's recall records this year. As early as March this year, the company announced it would recall a batch of injectable leukemia drug IDA rubicinhydrochloride after discovering silica and iron oxide particles in bottled medications during an internal inspection.

If a patient is injected with drugs contaminated by impurity particles, it may lead to mild side effects such as local irritation or swelling. However, if the particulate matter enters the bloodstream, these impurities can circulate throughout the body via the blood, potentially blocking blood vessels in the heart, lungs, or brain, which could result in a stroke or even death for the patient. Nevertheless, the company noted in late March that based on an internal health assessment, the likelihood of patients being harmed was minimal.

In addition, industry organizations predict that due to the long-standing difficulties at Teva's manufacturing plant in Irvine, California, there may be shortages of up to 24 generic sterile injectable drugs. The End Drug Shortages Alliance (EDSA) recently concluded that shortages of drugs produced at this plant, which are used to treat cancer, adult and pediatric diabetes, and pancreatic neuroendocrine tumors, are expected.

EDSA Indicates Potential Shortages of Vasodilator Alprostadil, Antibiotic Amikacin, and Chemotherapy Drugs Bleomycin, Dacarbazine, Idarubicin, Ifosfamide, Mitoxantrone, Streptozocin, and Topotecan, Along with Hormone Octreotide for Symptom Management in Intestinal Tumors. Other Injectable Agents Less Likely to Face Shortages Include Adenosine, Daunorubicin, Desmopressin, Epoprostenol, and More.

EDSA Urges Pharmaceutical Manufacturers to Timely Consider Increasing Production of Affected Drugs, While Advising Wholesalers to Stock Sufficient Supplies to Ensure Adequate Drug Availability. Additionally, EDSA Calls on the U.S. FDA to Expedite Approval of All Drug Applications Impacted by Plant Closures or Allow Importation of These Drugs, Especially in Cases Where No Alternatives Exist (e.g., Streptozocin for Pancreatic Cancer Treatment).

Last July, the U.S. FDA found during an inspection that the company had not repaired the damage to the water supply at the site, nor had it complied with preventive procedures to stop factory workers from spreading mold and bacteria. Teva also failed to ensure the proper functioning of sterile and pest control testing equipment. In response to the U.S. FDA's concerns about contamination at the plant, Teva was ultimately forced to halt operations at the facility. The contamination issues had already led the company to recall 2.5 million bottles of drugs earlier this year, which were used to treat cancer, arthritis, schizophrenia, and as muscle relaxants.

Reference Source:

1、Teva recalls one lot of blood disorder med after testing flags capsule woes

2、Teva's halt at troubled plant threatens to create shortages in wide range of injectable meds: report