Posts in category: News

By Elana Gotkine, HealthDay Reporter; Medically reviewed by Carmen Pope, BPharm.

Semaglutide products are being sold online, with products likely unregistered or unlicensed, according to a research letter published online Aug. 2 in JAMA Network Open.

Amir Reza Ashraf, Pharm.D., from the University of Pécs in Hungary, and colleagues conducted a risk assessment of semaglutide online sourcing. Websites advertising semaglutide without a prescription were cataloged in July 2023; those meeting inclusion criteria were selected for a product test buy protocol. Two 0.25mg dose prefilled pens or equivalent injection vials were ordered from each website and compared to genuine Ozempic brand 1mg semaglutide solution.

Six online vendors classified as not recommended or rogue and offering parenteral semaglutide products were included in the test buys. Three offered prefilled 0.25mg/dose semaglutide injection pens and three sold vials of lyophilized semaglutide. The researchers found that genuine Ozempic scored the full 22 points on the International Pharmaceutical Federation (FIP) checklist, while test purchased products scored 8 or 9; clear discrepancies were seen in regulatory registration information, accurate labeling, and evidence that products were likely unregistered or unlicensed. One sample had elevated endotoxin, indicating possible contamination. The presence of semaglutide was revealed in all samples, with considerably low purity levels (7 to 14 percent versus 99 percent advertised). In each sample, the measured semaglutide content substantially exceeded the labeled amount.

“Semaglutide products are actively being sold without prescription by illegal online pharmacies, with
vendors shipping unregistered and falsified products,” the authors write. “Two websites evaluated were
sent FDA warning letters for unlawful sale of unapproved and misbranded semaglutide.”
Read full article from JAMA Network.

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

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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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

Read more…

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

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. 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, 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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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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FDA Approves Vigafyde™ as the First and Only Ready-to-Use Vigabatrin Oral Solution

Pyros Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved Vigafyde™, the only ready-to-use vigabatrin oral solution, as a monotherapy for the treatment of pediatric patients 1 month to 2 years of age with infantile spasms (IS), where the potential benefits outweigh the potential risk of vision loss.

• Infantile spasms, a rare but severe form of epilepsy, pose significant challenges for patients and their families.
• Pyros provides ongoing personalized support to caregivers. The support program offers personal assistance and financial resources to caregivers whose child is starting or continuing therapy.
• Vigafyde™ is expected to be available in the second half of 2024.

Read more…