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Category: Med Alert

77 posts found

FDA Warns of Rare Drug Interactions with Antiseizure Drugs

The FDA issued a warning that the antiseizure medications levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is...
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FDA Warns of Risks with Ketamine Products

The FDA issued a warning regarding the use of compounded ketamine products for the treatment of psychiatric disorders. Ketamine is not FDA-approved for the treatment of any psychiatric disorder. It is important to note that ketamine is a mixture of...
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Pfizer Plant Damaged by Tornado: Drug Shortages May Occur

A key Pfizer pharmaceutical plant in North Carolina was damaged by a tornado, impacting the production of various pharmaceuticals, which will likely lead to shortages of certain medications. The plant produces anesthesia and other drugs, as well as nearly 25%...
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FDA to Update Prescribing Information for All Opioid Pain Medications

The FDA will be requiring several updates to the prescribing information for all opioid pain medications. All opioid pain medications will note that the risk of overdose increases as the dose increases, as well as a new warning about opioid-induced...
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Teva Pharmaceuticals Recalls Specific Lots of Fentanyl Buccal Tablets CII

Teva Pharmaceuticals has voluntarily recalled specific lots of various strengths of fentanyl buccal tablets CII at the consumer level due to a labeling error. This recall has been initiated because safety updates were omitted in the Product Insert/Medication Guide (MG)...
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Family Dollar Recalls Advil Not Stored at Proper Temperature

Family Dollar initiated a recall of various Advil (ibuprofen) over-the-counter products that were stored and shipped to certain stores on or around June 1, 2022 through March 31, 2023 by Family Dollar outside of labeled temperature requirements. Exposure to high...
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FDA Approves First OTC Naloxone Nasal Spray

The FDA approved Narcan (naloxone hydrochloride) 4mg nasal spray for over-the-counter (OTC) use – the first naloxone product approved for use without a prescription. Naloxone rapidly reverses the effects of opioids and is the standard treatment for opioid overdose. As...
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Opioid Manufacturers to Make Prepaid Mail-Back Envelopes Available at Pharmacies

The FDA will soon require opioid manufacturers to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients. The FDA issued notice to all opioid manufacturers that they are required...
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Certain HIV Medications to Discontinue

ViiV Healthcare, a GlaxoSmithKline company, communicated to the FDA that several HIV medications they manufacture will be discontinued by the end of 2023. Epzicom® (abacavir sulfate, lamivudine) 600/300mg tablets and Trizivir® (abacavir sulfate, lamivudine, zidovudine) 300mg/150mg/300mg tablets will be discontinued...
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Eli Lilly to Reduce Insulin Prices

Eli Lilly, one of three insulin manufacturers in the country, announced plans to reduce list prices of insulin by 70%. Humalog 100 units/mL will be reduced in price starting in Q4 of 2023. The price of nonbranded Insulin Lispro Injection...
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FDA Hopes to Make Naloxone Available Over the Counter

The FDA issued a Federal Register notice that assessed the safety and effectiveness of certain naloxone hydrochloride products for nonprescription use, hoping to make the opioid overdose reversal agent more accessible to the public. The preliminary assessment is intended to...
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FDA Approves Drug That Can Delay Onset of Type 1 Diabetes

The FDA approved Tzield® (teplizumab-mzwv) injection, a new drug that can delay the onset of type 1 diabetes by several months or years. Type 1 diabetes occurs when the immune system attacks and destroys the cells that make insulin, requiring...
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Label Mix-Up Leads to Atenolol and Clopidogrel Recall

Golden State Medical Supply, Incorporated initiated a voluntary recall of Clopidogrel 75mg Tablets (lot# GS046745) and Atenolol 25mg Tablets (lot #GS046745) due to a label mix-up. Atenolol is indicated for the treatment of hypertension, to lower blood pressure, while Clopidogrel...
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Quinapril and Hydrochlorothiazide Tablets Recalled Due to Impurity

Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg – fixed combination tablets indicated to lower blood pressure and treat hypertension – due to presence of Nitrosamine Drug...
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Laxative Recalled Due to Microbial Contamination Dangerous to Immunocompromised

Vi-Jon, LLC has issued a nationwide voluntary recall for all lots of magnesium citrate saline laxative oral solution lemon flavor, 10 FL Oz (296 mL) due to microbial testing that identified the presence of gluconacetobacter liquefaciens. This microbe can be...
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