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Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 8, 2024.
By Robin Foster HealthDay Reporter

Shingles can strike anyone who had chickenpox when they were young, and the intense pain that can accompany this body rash has sidelined many seniors. Here, one expert explains how and why shingles can surface, and what you can do to treat it, or better yet, avoid it. Shingles can happen at any age, but it most typically affects people over 50 who have stress and compromised immunity. “Shingles is caused by the varicella-zoster virus. It’s the same virus that causes chickenpox,” said Dr. Eugene Fellin, a family medicine physician at Penn State Health Medical Group – Fleetwood. “For most of us who grew up before the 1990s, when children began being immunized against chickenpox, we’ve been exposed to the virus and are at risk for shingles.”

How can shingles surface? After lying dormant in the nervous system for years, the virus can reemerge as shingles, which causes painful rashes that typically surface on the face or around the side of the torso, Fellin explained.

“It’s like a poison ivy rash that won’t go away,” he added in a Penn State news release.

“It can occur in, but along that same nerve root. A lot of times, people feel some tingling or a burning sensation prior to the rash actually breaking out,” Fellin noted. “When we’re looking for the rash, it will be in a string on the torso because the nerves wrap around the torso. You get a line around you, from the back to the front.”

“The other issue we worry about is if it breaks out on the face and involves the eye because this can lead to blindness,” Fellin said. “Shingles around the eye is considered dangerous, and an instant referral to an
ophthalmologist is always recommended.”

What can you take to treat shingles? Antivirals such as Valacyclovir can be prescribed, but they’re time-sensitive and need to be taken within 36 hours of the start of the rash because they work by slowing the spread of the virus, Fellin said.

While symptoms subside after three to five weeks, pain can sometimes return in the form of postherpetic neuralgia, he said. This long-term nerve pain occurs where the shingles rash appeared and can last for months or even years. Older adults are more likely to develop postherpetic neuralgia and have longer lasting and more severe pain, Fellin said. Luckily, there is something you can do to avoid shingles altogether: get vaccinated.

The U.S. Centers for Disease Control and Prevention recommends the Shingrix vaccine, given in two doses, with the second dose given two to six months after the first. People who get shingles can still receive the vaccine, which can lower the chances of another outbreak, Fellin noted.

Most family doctors and pharmacies stock the vaccine, which is covered by Medicare, he added. “Most insurance programs are covering it because it has been out long enough and shows a real benefit,” Fellin said in a Penn State news release. “There’s a lot of misinformation about vaccines circulating out there. My message is this: Don’t be afraid of this or any vaccine.”

SOURCE: Penn State Health, news release, Dec. 5, 2024

https://pennstatehealthnews.org/2024/12/the-medical-minute-shingles-and-its-shot-what-you-need-to-know-to-stay-healthy/

The flu (influenza) vaccine you get at your doctor’s office or pharmacy is the result of year-round work of highly skilled microbiologists, epidemiologists, physicians, and other public health experts. Sound complicated? It is.

As new strains of flu viruses emerge, the U.S. Food and Drug Administration closely coordinates with sister agencies and works with manufacturers to help the development of vaccines to protect from the flu, a disease that can cause severe illness.

The FDA and other parts of the U.S. Department of Health and Human Services are working to advance the development of new technologies for producing flu vaccines so we can better respond to influenza public health emergencies. All FDA-approved flu vaccines have been evaluated and determined to be safe and effective by the FDA.

There is often more than one type of flu virus circulating each season. So, vaccines are made to target the most likely viruses to circulate and cause illness in the U.S. during the upcoming flu season.

To find a flu vaccine near you, visit this page.

Source: FDA; Courtesy of Drugs.com

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FDA Grants Accelerated Approval to Bizengri for NRG1+ Pancreatic adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer

Merus N.V. has announced that the U.S. Food and Drug Administration (FDA) approved Bizengri (zenocutuzumab-zbco). This is the first and only treatment indicated for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC); that are advanced, unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion; who have disease progression on or after prior systemic therapy.

These indications are approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Bizengri has a Boxed WARNING for Embryo-Fetal Toxicity and warnings for infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD)/pneumonitis, and left ventricular dysfunction.

• Bizengri is a bispecific antibody that binds to the extracellular domain of HER2 and HER3 expressed on the surface of cells, including tumor cells, inhibiting HER2:HER3 dimerization and preventing NRG1 binding to HER3.
• The company plans to help appropriate patients gain access to Bizengri by providing resources and support based on each patient’s needs and situation.

Source: Meru N.V.

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FDA Approves Yesintek, a Biosimilar to Stelara

Biocon Biologics Ltd, announced that the U.S. Food and Drug Administration (FDA) has approved Yesintek (ustekinumab-kfce), a biosimilar to the reference product, Stelara® (ustekinumab).

Yesintek, a monoclonal antibody, is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. As a human interleukin-12 and -23 antagonist, Yesintek is indicated in the treatment of:

Adult patients with:

• moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy.
• active psoriatic arthritis (PsA).
• moderately to severely active Crohn’s disease (CD).
• moderately to severely active ulcerative colitis.

Pediatric patients 6 years and older with:

• moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.
• active psoriatic arthritis (PsA).

Source: Biocon Biologics Ltd.

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FDA Approves Rapiblyk for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting

AOP Orphan Pharmaceuticals GmbH announced that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for Rapiblyk (landiolol) in the hospital critical care setting for the treatment of the severe heart condition, supraventricular tachycardia. The approval is based on clinical studies which demonstrated that Rapiblyk (landiolol) enables rapid management of the heart rate with minimal reduction of blood pressure.

• Rapiblyk approval in the U.S. represents an important milestone for patients experiencing supraventricular tachycardia, including atrial fibrillation and atrial flutter, who need rapid and short-term heart rate reduction. The approval will provide patients in the U.S. with a new treatment option.

Source: AOP Orphan Pharmaceuticals GmbH

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FDA Approves Imkeldi Oral Solution for the Treatment of Certain Forms of Leukemia and Other Cancers

• Shorla Oncology has announced that the U.S. Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, to treat certain forms of leukemia and other cancers, and it is designed to provide dosing accuracy.
• Imkeldi can help slow or prevent the growth of specific cancers, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia, myelodysplastic syndrome /myeloproliferative disease (MDS/MPD), and gastrointestinal tumors (GIST).
• Imatinib mesylate is a tyrosine kinase inhibitor, approved by the FDA for use in certain forms of leukemia (such as acute lymphoblastic leukemia and chronic myeloid leukemia) and other cancers in adults and pediatric patients as young as one year old. Imatinib is available both generically and as a brand name, Gleevec tablets, which were approved in 2001.

Source: Shorla Oncology

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FDA Approves Attruby to Reduce Cardiovascular Death and Cardiovascular-Related Hospitalization in Patients with ATTR-CM

BridgeBio Pharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved Attruby™ (acoramidis), for the treatment of adults with cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization.

The FDA approval is based on positive results seen in the ATTRibute-CM Phase 3 study, where Attruby significantly reduced death and cardiovascular-related hospitalization, and improved quality of life.

• Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. It mimics a naturally occurring “rescue mutation” of the TTR gene that targets the root cause of ATTR-CM.
• Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes.

Source: BridgeBio Pharma, Inc.

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FDA Grants Accelerated Approval to Ziihera for the Treatment of HER2-Positive Biliary Tract Cancer

Jazz Pharmaceuticals plc has announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. Ziihera was approved under accelerated approval based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months as determined by independent central review (ICR).

• Continued approval for this indication may be contingent upon verification and description of
  clinical benefit in a confirmatory trial.
• Biliary Tract Cancer, including gallbladder cancer and intrahepatic and extrahepatic
  cholangiocarcinoma, account for <1% of all adult cancers globally and are often associated with a
  poor prognosis.

Source: Jazz Pharmaceuticals plc

FDA Approves Revuforj for the Treatment of Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation

Syndax Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj (revumenib) as the first and only menin inhibitor for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older. The FDA previously granted Breakthrough Therapy and Fast Track designations as well as Priority Review for Revuforj. The New Drug Application (NDA) received approval through the FDA’s Real Time Oncology Review (RTOR) program.

• Syndax expected that the 110 and 160mg tablets of Revuforj will be available for order in the United States through a network of specialty distributors and specialty pharmacies in November. Syndax expected that the 25mg tablets, which may be used to treat patients who weigh less than 40kg, will be commercially available in the late first quarter or early second quarter of 2025.
• Prior to commercial availability of the 25mg tablets, an oral solution of revumenib will be available through an expanded access program to allow for dosing of patients who weigh less than 40kg.

Source: Syndax Pharmaceuticals, Inc.

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FDA Approves Danziten Tablets, the First and Only Nilotinib with No Mealtime Restrictions

Azurity Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has approved Danziten. This is the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase, and in adult patients with chronic phase (CP), and acute phase (AP) resistant or intolerant to prior therapy that included imatinib.

• Tasigna® has established efficacy in adults with newly diagnosed Ph+ CML-CP and resistant or
  intolerant Ph+ CML-CP and CML-AP; however, Tasigna has variable bioavailability that considerably
  increases when taken with food.
• Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but
  without the fasting requirements of Tasigna.

Source: Azurity Pharmaceuticals, Inc.

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