Mushroom Poisoning

Across both recalls, Pfizer and Hospira said they hadn’t received any side effect or safety reports as of Dec. 21. After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. What’s more, the company’s latest product pulls threaten to intensify the ongoing shortages of several critical hospital drugs. Shortly before the holiday, Pfizer’s Hospira announced two separate recalls over the potential presence of glass particulates in vials and syringes of certain meds. In the case of injectable cancer medication bleomycin—of which Hospira is recalling one lot—a confirmed customer report alerted the company to the presence of glass particulates within a single vial, the company said in a notice posted on the FDA’s website. The second recall, which covers three drugs—two strengths of injectable sodium bicarbonate, plus one lot of atropine sulfate injection—kicked off after the company flagged “the potential presence of glass particulate matter” during routine product inspection. In both cases, Pfizer and Hospira said they hadn’t received any side effect or safety reports as of Dec. 21. Particulate contamination can have serious safety implications, and for hospital drugs especially so. Hospira, for its part, warned of the potential for “serious adverse events” should patients receive medications tainted with glass. Potential complications could include vein inflammation and the formulation of granulomas, or tiny clusters of white blood cells and tissue that arise as a reaction to infections and inflammation, irritants or foreign objects. Injecting a drug that contains glass particulates can also block vessels and lead to life-threatening blood clotting events, Hospira warned. “The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies,” Hospira noted in its press release. Thankfully, there are safeguards in place to prevent administration of a contaminated drug. Hospira pointed out that the labels for each drug covered in the recall contain statements directing healthcare professionals to visually inspect the products for particulate matter and discoloration prior to administration. The single batch of injectable bleomycin is stored in ONCO-TAIN glass fliptop vials, Hospira explained. The drug is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus. Bleomycin is often used in conjunction with other chemotherapies and can be used to treat malignancies like non-Hodgkin’s lymphoma, testicular cancer, ovarian cancer and cervical cancer. The single bleomycin batch comes one vial to a carton, with 112 vials stored in each case. The units were due to expire on June 30, 2024. Injectable sodium bicarbonate, meanwhile, is indicated to treat a range of conditions, from metabolic acidosis—a potential complication of severe kidney disease—to uncontrolled diabetes, cardiac arrest and circulatory insufficiency due to shock or severe dehydration. The medication can also be used to help reverse the effects of certain drugs like barbiturates or treat poisoning by salicylates or methyl alcohol, among other uses. The batches of sodium bicarbonate 4.2% and sodium bicarbonate 8.4% were expected to be good until Jan. 1, 2025, and Mar. 1, 2025, respectively. The final drug covered in the recall, atropine sulfate injection, is given parenterally for the temporary blockade of severe or life-threatening muscarinic effects—for example, as an antidote for organophosphorus or muscarinic mushroom poisoning. The medication can also help patients suffering from bradyasystolic cardiac arrest. The single atropine lot was set to expire on Feb. 1, 2025. Despite the frequency of Hospira recalls this past year—often over similar particulate concerns—Pfizer noted in the company’s press release that it places the “utmost importance on patient safety and product quality at every step in the manufacturing and supply chain process.” Still, this is hardly Hospira’s first recall rodeo. Late last December, Hospira recalled one lot of its antibiotic vancomycin hydrochloride at the 1.5-gram dose because of glass particles in vials. Glass concerns cropped up again in October, when Hospira yanked a single batch of 4.2% sodium bicarbonate injection with an August 2024 expiration date. The company also recalled a 1% lidocaine HCI injection lot with a June 2024 expiration date and a 2% lidocaine HCI injection lot with a July 2024 expiration date. Hospira, which Pfizer purchased for $17 billion in 2015, has a history of recall problems. Back in 2017 and 2018, the company issued several recalls of injectables due to problems with particulates, microbial growth and a human hair found in a syringe of one lot of 25% dextrose injection for infants. Hospira’s latest recalls come at an especially inopportune time. According to the FDA’s drug shortage database, myriad strengths of injectable sodium bicarbonate are in shortage right now. Hospira, for its part, credited the supply squeeze to shipping delays and increased demand. Other companies caught up in the sodium bicarbonate shortfall include Exela, Amphastar and Fresenius Kabi. Atropine sulfate injection is also in shortage from a range of drugmakers, according to the FDA.

GLENDALE HEIGHTS, Ill.--( BUSINESS WIRE )--Medefil, Inc., a domestic manufacturer of injectable products, has announced availability of its FDA-approved ANDA products, Atropine Sulfate Injection, USP, 1 mg per 10 mL (0.1 mg/mL), and 10% Calcium Chloride Injection, USP, 1000 mg per 10 mL (100 mg/mL). Both are offered in a single-dose prefilled syringe. These products are currently listed on the FDA drug shortage list and are available immediately for purchase from Medefil through national wholesalers. Atropine Sulfate Injection, USP, is used for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest. 10% Calcium Chloride Injection, USP is used for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels. “ Medefil is proud to supply two prefilled syringe products that have been approved by the FDA in a ready-to-administer format, critical for emergency situations,” said Pradeep Aggarwal, CEO & President of Medefil, Inc. “ We look forward to growing our injectables portfolio while maintaining our reputation as a consistent and reliable supplier of US developed and manufactured products.” For complete prescribing information and risks, please see the following link for Atropine Sulfate Injection, USP, and the following link for 10% Calcium Chloride Injection, USP. About Medefil, Inc. Medefil is a fully integrated specialty pharmaceutical company that develops, manufactures, and markets flush syringes and injectable drug products. The Company manufactures all products at its fully automated state-of-the-art facility in Glendale Heights, Illinois. Developing and manufacturing products at the highest quality levels with a reliable supply while ensuring safety for patients and ease-of use for providers is our key mission. For more information about Medefil, Inc. and our products, please visit https://www.medefilinc.com

PHILADELPHIA, Oct. 18, 2022 /PRNewswire/ -- One of the spookiest parts about this Halloween season has been the number of people being hospitalized after ingesting wild mushrooms. The recommendation from the Philadelphia regional Poison Control Center at Children's Hospital of Philadelphia (CHOP): Enjoy time exploring the outdoors, but unless you have an experienced mycologist (a mushroom expert with a scientific background in mushroom identification) to declare a wild mushroom safe to eat, do not eat any you may find. In the past month, eleven cases of wild mushroom poisoning due to foraging have been reported to the Poison Control Center. Seven of these cases led to hospitalizations, including three patients who were admitted to intensive care, including one who needed a life-saving organ transplant due to exposure. It's easy to underestimate how difficult it is to correctly identify a poisonous mushroom. Many poisonous wild mushrooms look almost the same as wild mushrooms that are edible or the cultivated mushrooms we buy at the grocery store and eat in our homes. In fact, sometimes they look so similar that even experienced foragers who are not experts are at risk of misidentifying a mushroom. Toxicologists are taught the old adage, "There are old mushroom pickers, and bold mushroom pickers, but NO old, bold mushroom pickers!" Additional key facts to remember about wild mushrooms: Symptoms from eating poisonous mushrooms may not appear for several hours to days after eating them. Cooking many wild mushrooms – especially those that may cause critical illness like liver failure – does not make them safe to eat. Your eyes can play tricks on you: differences in soil and climate can also make mushrooms that are highly toxic here look very similar to those that are perfectly safe to eat in other parts of the world. This is especially important for immigrants who might find wild mushrooms in the U.S. that look like edible mushrooms found in their country of origin, but are very poisonous. If a person has picked a wild mushroom and decides to eat it, they should take a picture of it before they eat it, including the top and bottom of the cap, the stem, and the base of the mushroom. If symptoms develop in the hours to days after eating, it is crucial to seek urgent medical care, and to bring the pictures to help identify the mushroom and guide appropriate treatment. If you think that you or someone you know has eaten a wild mushroom, call the Poison Control Center right away at 1-800-222-1222. This number will put you into contact with nurses, pharmacists, and doctors who are trained to recognize all types of poisonings. They will provide you and your family with expert, compassionate, and judgment-free care. Contact: Joey McCool Ryan (267) 258-6735 [email protected] SOURCE Children's Hospital of Philadelphia