FDA Warns Against Purchasing or Using Chemical Peel Skin Products Without Professional Supervision

The FDA is warning consumers not to purchase or use certain chemical peel skin products without appropriate professional supervision due to risk of serious skin injuries.

The agency has not approved any chemical peel products, and consumers should only consider using chemical peel products under the supervision of a dermatologist or licensed and trained practitioner. Many of these chemical peel products are sold in beauty product stores and online and marketed for purposes such as acne, discoloration, wrinkles, and collagen production. They contain ingredients such as trichloroacetic acid (TCA), glycolic acid, salicylic acid and lactic acid in varying concentrations that are too high to be used safely at home without supervision by a dermatologist or other licensed and trained practitioner.

Using products that contain high concentrations of these acids may lead to serious injury from chemical burns. The concentration, number of applications, and length of time a chemical peel product is left on the skin all influence how deeply it can penetrate skin layers and potentially lead to chemical burns.

These products remove layers of skin to varying depths and may cause severe chemical burns, pain, swelling, infection, skin color changes, and disfiguring scars. These injuries may even require emergency care or specialty care from a dermatologist or surgeon.

The FDA has issued warning letters to the following companies for selling these products:

The FDA encourages health care professionals and consumers to report adverse events or quality problems with these or any medications to FDA’s MedWatch Adverse Event Reporting program:

  • Complete and submit the report online; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.
    Source: FDA

ZUNVEYL

FDA Approves Zunveyl for the Treatment of Alzheimer’s Disease

Alpha Cognition has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Zunveyl (benzgalantamine) previously known as ALPHA-1062, for the treatment of mild-to-moderate Alzheimer’s disease.

Zunveyl, a novel oral therapy, has a dual mechanism of action designed to eliminate drug absorption in the GI tract, potentially addressing certain tolerability issues with leading AD medications, combined with the efficacy and long-term benefit profile of galantamine.

Source: Alpha Cognition

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ERZOFRI®

FDA Approves Erzofri for the Treatment of Schizophrenia and Schizoaffective Disorder

Luye Pharma Group announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Erzofri (paliperidone palmitate) extended-release injectable suspension, for treating schizophrenia in adults and for treating schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.

Erzofri, administered once a month, is the first patented paliperidone palmitate long-acting injection developed in China to get approved in the U.S.

  • Antipsychotic medications are used to treat and control symptoms of schizophrenia and
    schizoaffective disorder, but patient adherence to antipsychotics is generally poor. The use of longacting injectable (LAI) antipsychotics is effective in improving patient adherence.
  • Erzofri is not approved for use in patients with dementia-related psychosis, and the safety and
    effectiveness of Erzofri in pediatric patients have not been established.
    Source: Luye Pharma Group

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LEQSELVI

FDA Approves Leqselvi, an Oral JAK Inhibitor, for the Treatment of Severe Alopecia Areata

Sun Pharmaceutical Industries Limited announced that the U.S. Food and Drug Administration (FDA) approved Leqselvi (deuruxolitinib) 8mg tablets for the treatment of adults with severe alopecia areata.

The recommended dosage of Leqselvi for the treatment of severe alopecia areata is 8mg orally twice daily, with or without food.

Leqselvi is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors. Also, Leqselvi is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

Source: Sun Pharma

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Mounjaro Bests Ozempic for Weight Loss

Medically reviewed by Drugs.com.
By Dennis Thompson HealthDay Reporter

Mounjaro outperforms Ozempic in helping people lose weight, a new study shows. People taking tirzepatide (Mounjaro, Zepbound) dropped significantly more pounds than those taking semaglutide (Ozempic, Wegovy), researchers reported July 8 in the journal JAMA Internal Medicine.

“Individuals with overweight or obesity treated with tirzepatide were significantly more likely to achieve clinically meaningful weight loss and larger reductions in body weight compared with those treated with semaglutide,” concluded the research team led by Dr. Nicholas Stucky, Vice President of Research with Truveta Inc., a medical research collective.

For the study, researchers tracked more than 18,000 overweight and obese people who were prescribed either drug to help control their type 2 diabetes between May 2022 and September 2023. Both drugs initially were developed as type 2 diabetes medications but were later approved for use in weight loss.

Results show that both drugs are effective in promoting some weight loss. Nearly 82% of patients taking Mounjaro lost 5% or more of their body weight, compared to nearly 67% of those taking Ozempic, researchers found.

However, Mounjaro users were more likely to achieve greater weight gain. About 42% of Mounjaro patients lost 15% or more of their body weight, compared to about 18% of those taking Ozempic.

Overall, patients on Mounjaro were 76% more likely than those on Ozempic to lose 5% or more of their body weight; 2.5 times more likely to lose 10% or more of their body weight; and 3.2 times more likely to lose 15% or more of their body weight, results show.

Mounjaro patients also experienced larger reductions in body weight throughout their first year on the drug, researchers added.

After three months, Mounjaro patients had lost about 6% of their body weight compared to under 4% for Ozempic patients. The difference was 10% versus 6% at six months, and 15% to 8% at one year. Both drugs work by mimicking the effects of the gut hormone GLP-1, which plays a role in maintaining stable blood sugar levels. This action also slows digestion and increases satiety.

However, Mounjaro also stimulates a second gut hormone called GIP, which might explain the boosted effects found in this study.

Sources:

  • JAMA Internal Medicine, news release, July 8, 2024

Wegovy, Ozempic Lower Risk of Many Obesity-Related Cancers

Medically reviewed by Drugs.com.
By Robin Foster HealthDay Reporter

In yet another finding that touts the health benefits of wildly popular weight-loss medications like Wegovy and Ozempic, scientists report that taking the drugs may help reduce the risk of some cancers. In a study published July 5 in JAMA Network Open, researchers found people with type 2 diabetes who were being treated with a class of GLP-1 drugs were less likely to be diagnosed with 10 of 13 obesity-linked cancers than those who were taking insulin.

The reduction in risk was significant: Taking the medications cut rates of gallbladder cancer, meningioma, pancreatic cancer and hepatocellular carcinoma, a type of liver cancer, by more than half. Risks were also reduced for cancers of the ovaries, colon, esophagus, and kidneys as well as for multiple myeloma (a cancer of the bone marrow) and endometrial cancer (which begins in the lining of the uterus). Excess weight can trigger chronic inflammation and high levels of insulin, insulin-like growth factor and sex hormones. All of these can prompt the development of cancer, according to the U.S. Centers for Disease Control and Prevention. GLP-1 medications interact with systems related to insulin production, the researchers noted.

Importantly, the study found that taking GLP-1 drugs did not lower the risk of postmenopausal breast cancer, which CDC data show is the most common obesity-linked cancer. Risk was also not reduced for stomach cancer or thyroid cancer. Other early research has found that GLP-1s may interact with the body’s insulin production in ways that may harm the thyroid, CNN reported, and the study noted that patients should be aware of thyroid-related risks that are included in the medication’s packaging.

The researchers also found the risk of cancer for people with type 2 diabetes was not different among those who were treated with GLP-1s compared with those where were being treated with metformin. Kidney cancer risk was higher among those using GLP-1s, however. In the study, researchers from the Case Western Reserve University School of Medicine and the MetroHealth System analyzed more than a decade of medical records on nearly 1.7 million people with type 2 diabetes.

While more research is needed, the findings provide “preliminary evidence of the potential benefit of GLP-1RAs for cancer prevention in high-risk populations and support further preclinical and clinical studies,” the authors wrote.

Sources:

  • JAMA Network Open, July 5, 2024
  • CNN

GENERIC DRUG APPROVALS

July 2024

  • Indium In-111 Pentetreotide Injection Kit 3 mCi/mL
    Approved: July 1, 2024 – Sun Pharmaceutical Industries, Inc.
    Used for: Diagnosis and Investigation
    Generic for: Octreoscan
  • Bupivacaine Liposome Injectable Suspension 133mg/10mL (13.3mg/mL) and 266mg/20mL
    (13.3mg/mL)
    Approved: July 1, 2024 – Jiangsu Hengrui Pharmaceuticals Co., Ltd.
    Used for: Analgesia
    Generic for: Exparel

June 2024

  • Palbociclib Tablets 75mg, 100mg and 125mg
    Approved: June 5, 2024 – Synthon Pharmaceuticals, Inc.
    Treatment for: Breast Cancer
    Generic for: Ibrance Tablets
  • Avanafil Tablets 50mg, 100mg and 200mg
    Approved: June 14, 2024 – Hetero Labs Limited
    Treatment for: Erectile Dysfunction
    Generic for: Stendra
  • Phentermine Hydrochloride and Topiramate Extended-Release Capsules 3.75mg (base)/23mg,
    7.5mg (base)/46mg, 11.25mg (base)/69mg and 15mg (base)/92mg
    Approved: June 25, 2024 – Actavis Laboratories FL, Inc.
    Treatment for: Obesity
    Generic for: Qsymia

Main Products, Inc. Issues Recall of Umary Acido Hialuronico, SuplementoAlimenticio Due to the Presence of Undeclared Drug Ingredients

Main Products, Inc. is voluntarily recalling all lots of “Umary Acido Hialuronico, Suplemento Alimenticio – 30 Capletas de 850mg” to the consumer level. FDA laboratory analysis confirmed that UMARY has been found to be tainted with the drug ingredients, diclofenac and omeprazole. Products containing diclofenac and omeprazole cannot be marketed as dietary supplements. UMARY is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). There is a reasonable probability that consumption of high levels of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses.

Omeprazole is a proton pump inhibitor (commonly referred to as PPI) used to treat gastric (stomach) acidrelated disorders. PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea, and headache. This hidden ingredient may mask stomach issues such as erosions, ulcers, and stomach cancer, and it can also interact with other medications and should not be taken with certain medications. The product is used as a dietary supplement promoted and sold for pain and is packaged in bottles with 30 caplets. The affected product includes all lots within expiry. The product was distributed via online store Main Products, Inc. on Amazon.com.

Main Products, Inc. is notifying its customers by email and is arranging for the return of all recalled products. Consumers that have UMARY which is being recalled should stop using and return to their place of purchase. Consumers may return the products to the address below.

Main Products, Inc., 1551 Glenwood Springs Ave., Chula Vista CA, 91913
www.main-products.com.
Source: FDA

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Endo USA, Inc. Issues Recall of One Lot of Clonazepam Orally Disintegrating TabletsDue to Mislabeling: Incorrect Strength on Product Carton

Endo, Inc announced that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg tablets 60-count pack to the consumer level.

The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125mg and not 0.25mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25mg.

This recall impacts the following product lot:

  • See below image of correct carton label: Clonazepam Orally Disintegrating Tablets, USP 0.25mg 60-count carton, lot 550147301, expiration date August 2026
  • See below image of incorrect carton label: Clonazepam Orally Disintegrating Tablets, USP 0.125mg
    60-count carton, lot 550147301, expiration date August 2026

(Note: No BeneCard PBF members were affected by this recall.)
Source: FDA

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FEMLYV

FDA Approves Femlyv Orally Disintegrating Birth Control Pill

The U.S. Food and Drug Administration (FDA) approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy.

  • Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved
    in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968.
  • Femlyv is the first FDA-approved dissolvable birth control pill, designed for individuals who have
    trouble swallowing their medication.
    Source: FDA

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