Medication Monitor



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  • October 9, 2018

    FDA approved a supplemental application for human papillomavirus (HPV) 9-valent vaccine, recombinant (Gardasil 9), expanding the approved use to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

    Gardasil, a vaccine approved by FDA in 2006 to prevent certain cancers and diseases caused by four HPV types, is no longer distributed in the United States. In 2014, FDA approved Gardasil 9, which covers the same four HPV types as Gardasil, as well as an additional five HPV types. Gardasil 9 was approved for use in males and females aged 9 through 26 years.

    Effectiveness of Gardasil is relevant to Gardasil 9 since the vaccines are manufactured similarly and cover four of the same HPV types. In a study in approximately 3,200 women aged 27 through 45 who were followed for an average of 3.5 years, Gardasil was 88% effective in preventing a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.

    FDA’s approval of Gardasil 9 in women aged 27 through 45 is based on these results and new data on long-term follow-up from this study.

    Effectiveness of Gardasil 9 in men aged 27 through 45 is inferred from the data described above in women aged 27 through 45, as well as efficacy data from Gardasil in younger men (aged 16–26 y) and immunogenicity data from a clinical trial in which 150 men, aged 27 through 45, received a three-dose regimen of Gardasil over 6 months.

    Safety of Gardasil 9 was evaluated in approximately 13,000 males and females. The most commonly reported adverse reactions were injection-site pain, swelling, redness, and headaches.

    FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition. 
     

  • October 4, 2018

    BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level.

    King Bio Inc., a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that could have affected this product. King Bio has issued a recall of these active ingredients in BioLyte’s lot specific product. 

    Administration or use of drug products with microbial contamination could result in increased infections that may require medical intervention or that could be life threatening to certain individuals.

    Lot Number Expiry UPC Size Package type
    1138 1/31/2020 358368002021 2 oz white airless pump bottle
    1139 1/31/2020 358368002021 2 oz white airless pump bottle
    1146 3/29/2020 358368002045 4 ml 4” x 2” mylar foil pack
    1160 10/10/2019 358368002021 2 oz white airless pump bottle

    BioLyte Laboratories is notifying its retail partners, distributors, and customers by letter and is arranging for return and replacement of the recalled product.

    To date, there have been no reports of illness or injury due to use of this product.

  • October 4, 2018

    Paratek announced FDA approval of omadacycline 100 mg for injection/150 mg tablets for treatment of community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI) in adults.

    Omadacycline, a modernized tetracycline, is a once-daily I.V. and oral antibiotic that targets a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug-resistant strains.

    Approval was supported by multiple clinical trials involving nearly 2,000 adult patients.

    Warnings and precautions include the following:

    Use during tooth development (last half of pregnancy, infancy, and childhood to age 8) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

    Use during the second and third trimester of pregnancy, infancy and childhood up to age 8 years may cause reversible inhibition of bone growth.

    Omadacycline is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs.

    Clostridium difficileassociated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. 

    The most common adverse reactions (incidence ≥2%) in clinical trials were nausea, vomiting, infusion-site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.

    The drug is expected to become available in the first quarter of 2019.

     

  • October 3, 2018

    Amirall announced FDA approval of sarecycline, an innovative first-in-class tetracycline-derived oral antibiotic for treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged 9 years and older. 

    Sarecycline is an oral tablet that is taken once daily with or without food. It has proven to significantly reduce inflammatory lesions as early as 3 weeks after start of treatment and is generally safe and well tolerated. 

    Safety of the product was established in two 12-week multicenter, randomized, double-blind, placebo-controlled studies. Efficacy was assessed in 2,002 participants aged 9 years and older. Efficacy of sarecycline beyond 12 weeks and safety beyond 12 months have not been established.

    Sarecycline has not been evaluated for treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, patients should use sarecycline only as indicated. The product is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

    Use during tooth development may cause permanent discoloration of the teeth. If Clostridium difficileassociated diarrhea (antibiotic-associated colitis) or intracranial hypertension occurs, use should be discontinued. Central nervous system adverse effects, including light-headedness, dizziness, or vertigo, have been reported with tetracycline use. The most common adverse reaction is nausea.

    Sarecycline is expected to be launched in January 2019.

  • October 2, 2018

    Antares Pharma announced FDA approval of testosterone enanthate, the first testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone in adult males.

    The product is self-administered subcutaneously once weekly at home with an easy-to-use, single-dose, disposable QuickShot auto injector. It comes in three dosage strengths: 50 mg, 75 mg, and 100 mg.

    In Phase III clinical trials, the product was shown to produce physiologically normal levels of testosterone with a narrow peak-to-trough ratio. According to the principal investigator, the S.C. dosing removes transfer concerns commonly associated with gels and potentially reduces the need for in-office injection procedures that may require more frequent patient visits. 

    The product can cause blood pressure elevations that can increase the risk for major adverse cardiovascular events (MACE), including nonfatal myocardial infarction, nonfatal stroke and cardiovascular death, with greater risk for MACE in patients with cardiovascular risk factors or established cardiovascular disease.

    The most commonly reported adverse reactions in clinical trials were hematocrit increases, hypertension, prostate-specific antigen increases, injection-site bruising, and headache.

    Recommended dosage is 100–400 mg every 4 weeks.

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