July 20, 2018

Essure, accredited by the FDA in 2002, is a completely implanted contraceptive system that doesn’t require a surgical incision.

The Essure System for Everlasting Delivery Management will now not be accessible within the US after December 31, 2018, in keeping with a press launch issued by Bayer. The Firm states that the choice to discontinue Essure was primarily based on declining US gross sales and never on any adjustments to the benefit-risk profile of the product. 

Essure, accredited by the Meals and Drug Administration (FDA) in 2002, is a completely implanted contraceptive system that doesn’t require a surgical incision. The versatile coils are inserted by means of the vagina and cervix and into the fallopian tubes. Over ~three months, as tissue varieties across the inserts, a barrier is fashioned that stops sperm from reaching the egg.

In February 2016, the FDA required Bayer to conduct a post-marketing examine which resulted within the addition of a Boxed Warning and affected person determination guidelines to the labeling 7 months later. Following these adjustments, in April 2018, the Company issued an order to limit the sale and distribution of Essure after studying that some ladies have been nonetheless not being adequately knowledgeable of the dangers related to the system earlier than implantation. 

Adversarial occasions akin to perforation of the uterus and/or fallopian tubes, migration of inserts to the belly or pelvic cavity, persistent ache, and suspected allergic or hypersensitivity reactions has been reported in some ladies after Essure implantation.

Of their press assertion, Bayer notes that the “elevated reliance on different contraception choices, akin to long-acting reversible contraceptives, and inaccurate and deceptive publicity in regards to the system” is what contributed to the decline in curiosity for Essure. The Firm maintains that the security and efficacy of the system stays constant and that the rationale for this discontinuation is strictly business-related.

Assist providers for Essure will nonetheless be accessible by means of Bayer’s web sites Essure.com and EssureMD.com.  As well as, the Firm will proceed to enroll sufferers within the Essure postmarket surveillance examine, as requested by the FDA. In a press release launched by the Company, FDA Commissioner Scott Gottlieb, MD, mentioned “I need to stress that, even when Essure is now not offered, the FDA will stay vigilant in defending sufferers who’ve already had this system implanted. We’ll proceed to watch hostile occasions reported to our database, in addition to different knowledge sources. And we’ll talk publicly on any new findings or considerations.”

For extra data go to Bayer.US.

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Dolutegravir is an HIV-1 integrase strand switch inhibitor

The Meals and Drug Administration (FDA) has issued a security communication concerning the potential danger of neural tube delivery defects related to dolutegravir, an antiretroviral agent accredited to deal with HIV an infection. 

The Company has acquired reviews of significant neural tube delivery defects involving the mind, backbone, and spinal wire in infants born to ladies who acquired dolutegravir for HIV therapy. Preliminary findings from an observational research in Botswana confirmed that girls handled with dolutegravir on the time of turning into pregnant or early within the first trimester gave the impression to be at elevated danger for these delivery defects; no instances of infants born with neural tube defects have been reported amongst ladies who began dolutegravir later in being pregnant. 

Dolutegravir, an HIV-1 integrase strand switch inhibitor (INSTI), is indicated together with different antiretrovirals, to deal with HIV an infection. It’s out there beneath the model identify Tivicay (ViiV Healthcare) in addition to in a fixed-dose mixture with different antiretrovirals beneath the model names Juluca (dolutegravir, rilpivirine; ViiV Healthcare) and Triumeq (abacavir, dolutegravir, lamivudine; ViiV Healthcare).

In gentle of those reviews, the FDA recommends that clinicians ought to weigh the advantages and dangers of dolutegravir when prescribing antiretrovirals to ladies of childbearing age; the dangers and advantages of other therapies also needs to be thought of. Girls of childbearing age ought to use efficient contraception if the choice to make use of dolutegravir is made. As well as, being pregnant testing needs to be performed in ladies of childbearing age to exclude being pregnant earlier than beginning therapy with dolutegravir.

The FDA is constant to analyze the protection danger and can replace the general public when extra info is obtainable. 

PartoSure is a non-invasive check strip check that gives leads to 5 minutes or much less

PartoSure (Qiagen), a noninvasive check strip check to evaluate a lady’s threat of spontaneous preterm beginning, has been granted pre-market approval by the Meals and Drug Administration (FDA). 

The check, already accredited in 35 international locations, detects placental alpha microglobulin-1 (PAMG-1) in sufferers presenting with indicators and signs of preterm labor. The FDA approval is predicated on outcomes from a number of research, together with a latest research revealed in the journal Ultrasound in Obstetrics & Gynecology. This research in contrast the efficiency of PAMG-1 to fetal fibronectin (fFN) exams (the one different FDA accredited check out there for preterm beginning threat). 

Outcomes confirmed that a optimistic PAMG-1 check was ≥four occasions extra dependable than a optimistic fFN check in predicting imminent spontaneous preterm supply. “The FDA-approved PartoSure check will assist clinicians assess which moms face an imminent threat of preterm beginning, which ought to scale back healthcare prices and profit sufferers,” stated Thierry Bernard, SVP and head of Qiagen’s Molecular Diagnostics Enterprise Space.