CIENCIASMEDICASNEWS: FDA Patient Network News

miércoles, 6 de diciembre de 2017

FDA Patient Network News - December 6, 2017

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Medical Product Safety

Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues
Simple Diagnostics is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. More information

Updated Information on Limbrel Capsules by Primus Pharmaceuticals - Linked to Potentially Life-Threatening Health Problems
FDA has recommended that Primus Pharmaceuticals, Scottsdale, Arizona, voluntarily recall Limbrel, a capsule marketed to “manage the metabolic processes associated with osteoarthritis.” The company has not yet acted to remove the product from the market. Although the product is marketed as a medical food, the preliminary determination of the FDA investigation is that Limbrel is an unapproved new drug. The agency does not have mandatory recall authority over drug products. The FDA reminds consumers not to use Limbrel because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis. More information

Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label
During routine inspection of retained AlbuRx 25% samples CSL Behring noted the potential for fading print with more effect on the expiration dating on the patient tear off portion of the vial label. This is limited to 50 and 100 mL vial sizes. More information

Bull Capsules, Chao Jimengnan Tablets by Nutra Labs: Recall - Undeclared Drug Ingredients
Nutra Labs Inc. is voluntarily recalling lots sold by their firm of the male enhancement supplements Bull 1800 mg Capsules with the production date of 05/08/2016, and Chao Jimengnan 150 mg Tablets with Lot # 20151018 to the consumer level. FDA analysis found the products to be tainted with sildenafil, 0.026mg/capsule for Bull, and 70.46mg/tablet for Chao Jimengnan respectively. More information

Biotin (Vitamin B7): Safety Communication - May Interfere with Lab Tests
The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. Biotin in blood or other samples taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically significant incorrect lab test results. The FDA has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests.
More information

Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination
Sun Pharmaceutical Industries is recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), which were found to be contaminated with Scopulariopsis brevicaulis. Use of the affected Riomet potentially could result in a risk of infection, especially in the immunocompromised patient. The most plausible portal of entry of Scopulariopsis brevicaulis is the respiratory tract, where it may cause pneumonia, sinusitis and disseminated infections. More information

Medical Product Approval

First biosimilar for the treatment of certain breast and stomach cancers approved
FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors over-express the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer. More information

First implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients approved
FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses. Cataracts are a common eye condition where the natural lens becomes clouded, impairing a patient’s vision. More information

FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers
FDA approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing (NGS)-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The Centers for Medicare & Medicaid Services (CMS) at the same time proposed coverage of the F1CDx. The test is the second IVD to be approved and covered after overlapping review by the FDA and CMS under the Parallel Review Program, which facilitates earlier access to innovative medical technologies for Medicare beneficiaries. More information

First once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder
FDA approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. It is indicated for patients that have been on a stable dose of buprenorphine treatment for a minimum of seven days. More information

From the Commissioner

PEPFAR: FDA Approves 200th HIV/AIDS Therapy, by: Scott Gottlieb, M.D., Commissioner of FDA
Since 1981, when the first case of AIDS was reported in this country, U.S. and foreign governments, scientists, grassroots and global community health organizations, patients, and their families have worked hard to address the impact of this virus. HIV/AIDS is responsible for one of the most destructive pandemics in human history.

World AIDS Day is a time for us to honor the 36 million people who have died from AIDS and HIV infections, to rededicate ourselves to helping the more than 35 million people living with HIV/AIDS today, and to pay tribute to the caregivers, families, and communities who support them. More information

FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices
Once considered a futuristic technology on the distant horizon, 3D printing of medical devices, medications and human tissue is quickly becoming a promising reality. Patients have already benefited from 3D printed medical products through access to personalized devices and innovative drugs that have led to significant health improvements. But the FDA is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice. More information

Upcoming Public Meetings

Most FDA meetings are free to the public and do not require the public to register. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees.

View FDA Patient Network Calendar of FDA Sponsored Public Meetings for a list of meetings and workshops that may be of interest to patients and caregivers.

Opportunity to Comment

FDA rules have great impact on the nation’s health, these rules are formed with the public's help. By law, anyone can participate in the rule-making process by commenting in writing.

View FDA Patient Network Opportunity to Comment on Current Draft Guidance page, for a list of current draft guidances and other topics of interest for patients and caregivers.

Drug Shortages

Drug Discontinuation Voluntarily Reported by Manufacturers During the Past 2 Weeks:

FDA knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the company to restore supplies while also ensuring safety for patients.

More information on drug shortages and discontinuations: Drug Shortage Database and Vaccines, Blood and Biologic Shortages

FDA Announcements

Pediatric X-ray Imaging
Medical X-ray imaging has led to improvements in the diagnosis and treatment of numerous medical conditions in pediatric patients. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients as persons aged 21 or younger at the time of their diagnosis or treatment. Typically these are broken down into different groups based on age ranges (neonates, infants, children, and adolescents). For medical X-ray imaging, the pediatric patient's size is even more important to consider than age, because patient size determines how much radiation is needed to produce a quality medical image. More information

FDA’s Role in Foreign Drug Manufacturing - Webinar
FDA Drug Info Rounds pharmacists discuss how FDA works with both domestic and foreign drug manufacturers to help ensure that products distributed within the United States meet U.S. requirements and standards for product safety and quality. More information

Food Safety

Learn How to Prepare Your Meals Safely
The food supply in the United States is among the safest in the world. However, when certain disease-causing bacteria or pathogens contaminate food, they can cause food-borne illness, often called “food poisoning.” The Federal government estimates that there are about 48 million cases of food-borne illness annually – the equivalent of sickening 1 in 6 Americans each year. And each year, these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths. More information

Consumer Updates

Laser Toys: How to Keep Kids Safe
Many kids (and parents) who have seen Luke Skywalker battle Darth Vader with a light saber think lasers are cool. What they may not know is this: When operated unsafely, or without certain controls, the highly-concentrated light from lasers—even those in toys—can be dangerous, causing serious eye injuries and even blindness. And not just to the person using a laser, but to anyone within range of the laser beam.More information

Raw Dough's a Raw Deal and Could Make You Sick
Do you find it hard to resist gobbling up a piece of raw dough when making cookies, or letting your children scrape the bowl? Do your kids use raw dough to make ornaments or homemade “play” clay? Do you eat at family restaurants that give kids raw dough to play with while you’re waiting for the food? If your answer to any of those questions is yes, that could be a problem. Eating raw dough or batter—whether it’s for bread, cookies, pizza or tortillas—could make you, and your kids, sick, says Jenny Scott, a senior advisor in FDA Center for Food Safety and Applied Nutrition. More information