June 2012 Safety Labeling Changes includes 35 products with revisions to Prescribing Information

The MedWatch June 2012 Safety Labeling Changes posting includes 35 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

Jul 12th, 2012


The "Summary Page" provides a listing of drug names and safety labeling sections revised.

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and/or WARNINGS sections:

Avodart (dutasteride)
Bepreve (bepotastine besilate) 1.5% ophthalmic
CellCept (mycophenolate mofetil)
CellCept (mycophenolate mofetil hydrochloride)
Estraderm (estradiol) transdermal
Helidac Therapy (bismuth subsalicylate, metronidazole and tetracycline hydrochloride)
Incivek (telaprevir)
Jalyn (dutasteride and tamsulosin HCL)
Methergine (methylergonovine maleate)
Myfortic (mycophenolic acid)
Noxafil (posaconazole)
Prezista (darunavir)
Prinivil (lisinopril) tablets and
Prinzide(lisinopril/hydrochlorothiazide)
Privigen Immune Globulin Intravenous (Human) 10%
Stelara (ustekinumab)
Strattera (atomoxetine hydrochloride)
Sustiva (efavirenz)
Vesicare (solifenacin succinate)
Zithromax (azithromycin)
Companies in this article
FDA
Chris Coggan, CEO and lead designer of Therapy Tonics.
Catch 22s and Opportunity in Cannabis Packaging
An established brand owner says ‘…if you're a small brand trying to get started, especially with bootstrap money like ours,’ minimum order quantities represent a hurdle.
Feb 21st, 2020
Belviq
Quick Hits: Weight Loss Drug Linked to Cancer
Clinical trials showed an increased risk of cancer in patients who took an oral medication intended for obese adults.
Feb 21st, 2020
MiniMed 600 Series
Quick Hits: Medtronic Insulin Pumps Recalled
Malfunctions of the MiniMed600 Series insulin pumps could cause serious injury or death, and have prompted a Class I recall.
Feb 20th, 2020
VR piqued the company’s interest because it seemed to be the only medium that could transcend boundaries in a remote way to enable both instruction and hands-on skill building focused on the “why.”
Machine-Agnostic VR Comes to Sterile Manufacturing Education
You’ve heard of OEMs offering augmented reality tools, but virtual reality has come to pharmaceutical processing training. How does improved critical thinking impact the bottom line?
Feb 19th, 2020
Skin Thread Capabilities
Quick Hits: Skin Yarn is the Newest Way to Treat Wounds
French researchers have created yarn made from human skin cells that integrates with the body to promote healing.
Feb 19th, 2020
Portable Lab
Portable Lab Diagnoses Illnesses
Researchers at University of Cincinnati have developed a small portable lab that connects to a smartphone and communicates directly with doctors.
Feb 18th, 2020
Drawing Blood
Quick Hits: Robots Draw Blood Better Than Humans
A robotic blood drawing and testing device outperformed healthcare professionals in a clinical trial.
Feb 17th, 2020
Pioneering New Cannabis Packaging Standards
Pioneering New Cannabis Packaging Standards
A myriad of challenges face cannabis packagers, from state-to-state regulatory requirements to adapting machinery and processes specifically to the cannabis market.
Feb 14th, 2020
Acquiring the production line should strengthen the company's market position for specialty cans.
Hoffmann Neopac Strengthens Market Position
The company acquires hinged lid can production lines from Trivium Packaging.
Feb 14th, 2020
Science Photo Library Rf
Quick Hits: “Breakthrough” Cancer Drugs Take Too Long to Reach NHS
A new study found that “breakthrough” cancer drugs take 22 years to reach patients on the National Health Service.
Feb 14th, 2020
Vision Implant and Glasses
Quick Hits: New Implant Bypasses Eyes to Help The Blind See
Researchers have developed a device that plugs directly into the brain to give blind people rudimentary vision.
Feb 13th, 2020
Peanut Allergy Drug
Quick Hits: FDA Approves Peanut Allergy Drug
The FDA just approved the first drug to treat life-threatening peanut allergies in children.
Feb 12th, 2020
Jcm4026
Previewing PACK EXPO East 2020
With one-third of the nation’s CPGs, and many pharma manufacturers, located within 200 miles of Philadelphia, PACK EXPO East 2020 promises the full PACK EXPO vibe in an easy-to-get-to location.
Jan 31st, 2020
Sweat Sensor
Quick Hits: New Device Uses Sweat for Real-Time Well-Being Data
Scientists at North Carolina State University created a sweat-sensing wearable that gathers health information.
Feb 11th, 2020
Honeywell Bigfinite Collaboration 300 Dpi
Honeywell Collaborates With AI Specialist Bigfinite to Speed Medical Therapies
The collaboration will focus on helping biotech and pharma industries understand and make use of artificial intelligence and machine learning to enable faster development.
Feb 10th, 2020
Machine used to extract CBD from Cannabis plants
OEMs Needed for $32 Billion Budding Cannabis Industry
Automated operations are the wave of the future in a growing industry that is expected to reach $32 billion globally by 2024, with a CAGR of 28%. Off the record, OEMs report cannabis companies get sticker shock!
Feb 10th, 2020
Storms, fires, floods, even volcanic eruptions, are playing havoc with supply chain partners.
Weather Stresses Logistics
Responding to consumer demands to “get it to my doorstep in a day,” the nation’s supply chain leaders now have to adjust to crazy climate events around the globe. Reusable transport packaging could hold one key to a more sustainable future.
Feb 10th, 2020
Butterfly Effect cannabis flower is packaged in an aluminum can with a child-resistant reclosable cap.
Integrated Labeling Strategy Helps Cannabis Company Grow
Medical marijuana startup Grow Ohio employs a combination of label software, printing systems, and label materials to meet compliance regulations and branding for six different packaging formats.
Feb 10th, 2020
Diagnostic Test
Quick Hits: FDA Prioritizes Coronavirus Diagnostic Test
Last week, the FDA issued emergency approval for a coronavirus diagnostic test to expedite diagnoses in the US.
Feb 10th, 2020
Salary Survey 2020 Image
Take the 2020 IoPP Salary Survey!
The Institute of Packaging Professionals’ (IoPP) annual Salary Survey is the packaging industry’s definitive economic/employment survey. Packaging field professionals are invited to participate.
Feb 7th, 2020
More in Home
Walgreen's Pharmacy
Quick Hits: Unlicensed Pharmacist Costs Walgreens $7.5M
Walgreens will pay a large settlement in a consumer protection lawsuit resulting from the employment of an unlicensed pharmacist.
Feb 7th, 2020
Credence MedSystems, one of two winners in the “Best Innovation in Drug Delivery Device,” was chosen for its Connect™ Auto-Sensing Injection System, which incorporates real-time monitoring of critical injection data into a reusable ergonomic grip. The Credence app also measures and transmits injection progress in real-time, as well as providing users with reminders and instructions on how to use the auto-injector.
2020 Pharmapack Award Winners Announced
The Pharmapack Awards celebrate the latest innovations from packaging companies within the drugs, medical devices, health products and veterinary drugs sectors.
Feb 6th, 2020
Firefighters
Quick Hits: New Handheld Device Prints Skin on Burn Wounds
A team of researchers in Canada developed a bioprinter that treats severe burns by printing new skin cells onto the injury.
Feb 6th, 2020
Fda Stock Image
FDA: Draft Guidance Q&A on Promotional Labeling and Advertising for Reference or Biosimilar Products
Comment on the draft by Apr. 6, 2020 before work begins on the final guidance.
Feb 5th, 2020
Dsc 9599
All-Paper Blister Package
The Alloyd Division of Sonoco introduces EnviroSense PaperBlister, an all-paper retail blister package designed as an alternative to traditional thermoformed plastic blister packages.
Feb 5th, 2020
Source: Here to Stay or Up in Smoke? A look at the U.S. cannabis market, by PMMI Business Intelligence. Download the whitepaper for free at pwgo.to/3349.
For the Umpteenth Time, Cannabis Market Hard to Define
The cannabis market remains fragmented and divisive.
Feb 5th, 2020
Purell Hand Sanitizer
Quick Hits: FDA Cracks Down on Purell Hand Sanitizer Claims
The FDA warned Purell to stop making unproven claims about their product’s ability to help eliminate Ebola, MRSA, and the flu.
Feb 5th, 2020
Drug-Coated Nanowires
Quick Hits: Magnetic Nanorobots Target Cancer Cells
Drug-coated iron nanowires guided by external magnetic fields could revolutionize cancer therapy.
Feb 4th, 2020
Gov. JB Pritzker
Quick Hits: Illinois Caps Insulin Costs at $100/Month
Governor JB Pritzker signed a new law that limits out of pocket insulin costs at $100 for a 30-day supply.
Feb 3rd, 2020
Best Practices for Conveyor Safety
Best Practices for Conveyor Safety
See what the Conveyor Equipment Manufacturers Association (CEMA) has to say about conveyor-specific safety programs and materials that are available for your facility.
Jan 31st, 2020
Human on a Chip
Quick Hits: Forget the Organ-on-a-Chip; Now There’s a Human-on-a-Chip
Researchers from Tel Aviv and Harvard University have developed a ‘human-on-a-chip’ that will accelerate the drug testing process.
Jan 31st, 2020
World Health Organization (WHO) declared the Wuhan coronavirus outbreak a global health emergency.
W.H.O.: Global Emergency Declared as Wuhan Coronavirus Spreads
Most of the 8,000 cases have been reported in mainland China.
Jan 30th, 2020