Teva’s recall of products due to poor drug dissolution may lead to a shortage of 24 injections
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Teva’s recall of products due to poor drug dissolution may lead to a shortage of 24 injections
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Teva’s recall of products due to poor drug dissolution may lead to a shortage of 24 injections.
During routine stability testing of its thrombocytosis drug Anagrelide, Teva discovered poor dissolution issues.
Teva is recalling a batch of 0.5 mg doses of Anagrelide capsules in the U.S. market due to a failed drug dissolution test, which took longer for patients to dissolve after taking the drug. Other batches have not been affected for the time being.
In a notice on the FDA’s website, Teva warned that taking Anagrelide capsules that don’t dissolve properly would inhibit or counteract the drug’s platelet-reducing effects.
Poorly dissolving capsules can hinder the effectiveness of the drug or even render the treatment ineffective, and taking these problematic Anagrelide capsules can have fatal effects in patients with severe blood disorders.
As of Monday, Teva said it had not received any quality complaints or reports of side effects from the suspect batch.
Between July 30 and September 2, 2020, the company distributed a total of 4,224 bottles in the U.S. market, with the batch of Anagrelide capsules in question expiring this month.
Anagrelide capsules were previously approved by the US FDA for the treatment of thrombocytosis secondary to myeloproliferative neoplasms.
Specifically, the body of a person with thrombocytosis produces too many platelets, causing bleeding and abnormal blood clotting, putting the patient at risk for a heart attack or stroke.
Teva explained that poor dissolution of Anagrelide capsules designed to reduce platelet counts may slow the rate and extent of drug release, reducing the amount of Anagrelide available in the patient’s body, making it difficult for patients to avoid blood clotting and bleeding. or coagulation and bleeding events.
It’s worth noting that this isn’t the first time Teva has appeared on FDA recall records this year. Back in March, the company said it was recalling a batch of injectable leukemia drug IDA rubicinhydrochloride after an internal inspection found that the bottled drug contained silica and iron oxide particles.
Mild side effects, such as local irritation or swelling, may occur if a patient is injected with a drug contaminated with foreign particles, but if the particulate matter reaches the blood vessels, these impurities can circulate with the bloodstream to various organs of the body and block the heart, lungs, or brain of the patient. blood vessels, leading to stroke and even death.
However, the company noted in late March that the likelihood of patient harm determined based on internal health assessments is low.
On top of that, industry groups predict that the chronically troubled Teva manufacturing plant in Irvine, Calif., could lead to a shortage of as many as 24 generic sterile injectable drugs.
The Ultimate Drug Shortage Alliance (EDSA) recently concluded that there will be shortages of medicines made at the facility to treat cancer, diabetes in adults and children, and pancreatic neuroendocrine tumors.
The EDSA said the most likely shortages were the vasodilator alprostadil, the antibiotic amikacin, and the chemotherapy drugs bleomycin, dacarbazine, idarubicin, ifosfamide, mitoxantrone, streptozotocin Uzotocin and topotecan, as well as the hormone octreotide, are used to treat symptoms of intestinal tumors.
Other injectables that are unlikely to face shortages are adenosine, daunorubicin, desmopressin, epoprostenol, and others.
The EDSA urges drugmakers to consider the need to increase production of the affected drugs in a timely manner, while recommending that wholesalers stock up on sufficient supplies to ensure adequate availability of the drugs.
In addition, EDSA calls on the FDA to expedite approval of all drug applications affected by plant closures, or to allow the importation of these drugs, especially some where alternatives are not available (such as streptozotocin for pancreatic cancer).
In July last year, an FDA inspection found that the company had not repaired water damage at the site, had not followed procedures to prevent the spread of mold and bacteria by factory workers, and Teva had failed to ensure sterile and pest testing equipment was working properly.
Teva had to eventually halt operations at the plant in response to FDA concerns about contamination at the plant.
Contamination issues have already led to the company being forced to recall 2.5 million vials earlier this year for cancer, arthritis, schizophrenia and muscle relaxants, among other drugs.
Reference:
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
Teva’s recall of products due to poor drug dissolution may lead to a shortage of 24 injections
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