FDA MedWatch - January 2011 Safety Labeling Changes; 43 products with revisions to Prescribing Information

The MedWatch January 2011 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

Mar 10th, 2011
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

Carbatrol (carbamazepine)
EES (erythromycin ethylsuccinate)
Ery-Ped (erythromycin ethylsuccinate)
PCE (erythromycin particles in tablets) Dispertab
Gelnique (oxybutynin chloride) 10% gel
Uloric (febuxostat tablets)
Zithromax (azithromycin)
Actonel (risedronate sodium)
Actonel with Calcium (risedronate sodium with calcium carbonate tablets, USP)
Atelvia (risedronate sodium)
Boniva (ibandronate sodium)
Coreg (carvedilol)
Coreg CR (carvedilol phosphate)
Cyklokapron (tranexamic acid)
Folotyn (pralatrexate)
Fosamax (alendronate sodium)
Fosamax Plus D (alendronate sodium/cholecalciferol)
Kayexalate (sodium polystyrene sulfonate)
Oxytrol (oxybutynin transdermal system)
Prilosec (omeprazole)
Prilosec (omeprazole magnesium)
Reclast (zoledronic acid)
Rituxan (rituximab)
Sanctura (trospium chloride)
Sanctura XR (trospium chloride extended release capsules)
Tasigna (nilotinib)
Tessalon (benzonatate)
Trelstar (triptorelin palmoate)
Viagra (sildenafil citrate)
Zoladex (goserelin acetate)
Activ-Blister Packaging / Image: Aptar
FDA Approves Activ-Blister™ Packaging for HIV Drug
The FDA has approved AptarGroup’s packaging solution for oral solid dose HIV prevention medicine.
Oct 25th, 2019
Holographic foils can be used to great effect to differentiate product at the point-of-sale.
Using Holography to Fight Pharmaceutical and Healthcare Brand Piracy
Column: New trends in pharma packaging follow developments in emerging markets, demographic changes and new technologies that include holography, says chairman of the International Hologram Manufacturers Association.
Oct 24th, 2019
Baby Powder / Image: Flickr
FDA Finds Asbestos in Baby Powder, Recall Ensues
Johnson & Johnson recalled thousands bottles of their famous baby powder after the FDA found trace amounts of asbestos.
Oct 24th, 2019
Yourway Mitigates Uncertainty of Brexit for Clinical Trials in Europe
Their new location is strategically placed to accommodate both the UK and mainland Europe.
Oct 21st, 2019
Digital Network Platform to Further Transform the Global Pharmaceutical Supply Chain
TraceLink: Digital Network Platform to Further Transform the Global Pharmaceutical Supply Chain
The platform is designed to allow users to rapidly design and deploy network orchestration and analytics applications, enabling patient-centric orchestration across the end-to-end life sciences value chain.
Oct 17th, 2019
Schreiner MediPharm's Flexi-Cap Prime has a combined tear strip for the label and cap
Schreiner MediPharm: Tamper-Evident Flexi-Cap Prime for Vials
The tear strip is designed to ensure that undetected reuse of a container is no longer possible.
Oct 16th, 2019
Duane Niedert, Director of Operations – Americas for Smithers
Smart Packaging: ‘A Tale of Two Technologies’
A presentation at SmartPack 2019 delves into the current status, forecast, and drivers of the two categories of technology—smart and active—that make up smart packaging.
Oct 15th, 2019
Migrane Drug Needed / Image: Getty
FDA Approves New Acute Migraine Drug
Eli Lilly’s new drug Reyvow relieves pain, nausea, and light sensitivity in within two hours of ingestion.
Oct 14th, 2019
Descovy / Image: Gilead
FDA Approves HIV Drug, But Only for Men
Gilead Sciences only tested Descovy on men and transgender women, and the approval explicitly excludes cisgender women.
Oct 10th, 2019
Zantac and generic versions of the popular heartburn medicine face concerns about contaminants.
How QR Codes Can Help Drug Makers Streamline Recalls
Concerns about a carcinogenic impurity have prompted recalls of Zantac and generic versions of the popular heartburn medication. Smart labeling technology could speed and clarify alerts to consumers and also help drug companies reduce scrapped lots.
Oct 9th, 2019
Infant Werewolf Syndrome / Image: Shutterstock
Mislabeling Leads to 17 Cases of Infant “Werewolf Syndrome”
Children in Spain have developed hypertrichosis after a reflux drug was contaminated with alopecia treatment.
Oct 9th, 2019
Visible Particulate FDA Recall Notices by year as compiled by John Shabushnig, Insight Pharma Consulting, from FDA data. Reprinted with permission.
Particles in Parenterals: 2019 Update
FDA expects a visual inspection program and parenteral manufacturers should expect questions about their program during any inspection. What's new in 2019?
Oct 4th, 2019
Toshiba’s new thermal barcode printer, the B-EX4T3HS, prints at 600 dpi at speeds up to 6 in/s.
High-Precision Printer Eases Compliance in Medical Packaging
Toshiba’s latest thermal barcode printer combines high-resolution printing with high precision in label feeding to print small labels.
Oct 3rd, 2019
Opioids / Image: iStock
FDA and DEA Target More Illegal Opioid Websites
In the continued fight against the opioid crisis, the FDA and DEA issued joint warning letters to websites illegally marketing and selling opioids.
Oct 3rd, 2019
Systech, a global technology provider of digital brand protection and authentication, launched its Systech Brand Protection Suite™.
Digital Brand Protection: Fingerprinting for Serialized and Non-Serialized Products
Systech’s next-generation platform is a brand protection suite that integrates fool-proof product authentication with serialization, traceability and insight.
Oct 2nd, 2019
NUsurface Meniscus Implant / Image: Active Implants
First Artificial Meniscus is an FDA Breakthrough Device
The FDA has designated the first artificial meniscus implant a breakthrough device, expediting its review process.
Sep 26th, 2019
Saleable Returns Enforcement Delayed to 2020
Saleable Returns Enforcement Delayed to 2020
FDA final guidance says distributors will not be required to verify the product identifier of returned drugs before resale until 27 November 2020.
Sep 25th, 2019
Panel Alert: White Paper on Smart Asset Technologies
Panel Alert: White Paper on Smart Asset Technologies
Tuesday panel to introduce the new report on identification, monitoring and tracking of reusable transport packaging assets.
Sep 23rd, 2019
Eric Greenberg
Cannabis Research Lights Finally Turn Green
DEA makes a move to help increase the availability of cannabis for medical research.
Sep 20th, 2019
Holograms are an effective tool against counterfeiters and fraudsters.
New Anti-Counterfeiting Packaging Report Highlights Holography
Latest intelligence predicts the global market for anti-counterfeiting packaging will reach almost US$ 250 bn by 2026.
Supplier Submitted
Sep 20th, 2019
More in Regulatory
PCI Unveils Clinical Center of Excellence
Expanded clinical services facility in Rockford, IL to support growth and flexibility with 30,000 additional sq ft.
Sep 19th, 2019
Zantac 150 / Image: Amazon
Cancer-Linked Contaminant Found in Heartburn Pills
Low levels of NDMA have been found in samples of the heartburn medication Zantac, according to the FDA.
Sep 18th, 2019
DSCSA: Where Are We, and Where Are We Going?
DSCSA: Where Are We, and Where Are We Going?
Recapping current progress, the Nov. 2019 saleable returns deadline and the supply chain transformation expected in 2023.
Sep 17th, 2019
Recalled Drugs / Image: CPSC
Packaging Issues Lead to Recall of Blood Pressure and Cholesterol Medication
Sandoz is recalling a high blood pressure and high cholesterol medication because their packaging wasn’t childproof.
Sep 12th, 2019
Kezzler Announces Industry’s First Grass-to-Glass Traceability and Consumer Engagement for Infant Formula Brand, Friso
Grass-to-Glass Traceability and Consumer Engagement for Infant Formula Brand, Friso
Kezzler enables FrieslandCampina to reinforce transparency and build trust with Chinese consumers.
Sep 9th, 2019
Marijuana / Image: MrDr
DEA to Finally Expand Marijuana Research
It took a lawsuit for the DEA to expand the number of entities authorized to grow marijuana for research purposes.
Sep 6th, 2019
Company Reports Three out of Ten 2D Barcodes Failing, Letter Stresses Saleable Returns Challenges
Company Reports Three out of Ten 2D Barcodes Failing, Letter Stresses Saleable Returns Challenges
Returns verification requirement deadline is approaching fast.
Sep 5th, 2019
FDA / Image: FiercePharma
FDA Says No More Reusable Duodenoscopes
After years of sterilization issues, the agency is urging device makers to transition to disposable duodenoscopes.
Sep 4th, 2019
Lidocaine Recall / Image: EPR
Lidocaine Products Recalled Due to Label Issue
Lidocaine topical cream and liquid gel products have been recalled due to higher content than label states.
Aug 30th, 2019
Vape-Related Seizure / Image: Alastair Pike
FDA Investigating 120 Vape-Related Seizures
The CDC and FDA are working with state health authorities to investigate the increase in pulmonary illnesses linked to e-cigarette use.
Aug 29th, 2019
Healthcare Compliance Packaging Council Comments on “Fixed Quantity Unit of Use Blister Packaging for Certain Immediate Release Opioid Analgesics for Treatment of Acute Pain
Healthcare Compliance Packaging Council Comments on FDA's Look at Unit of Use Blister Packaging for Certain Opioids
The Council notes that limited doses in properly designed blisters will not only mitigate overuse, but also limit excess unused doses—frequently the source of diverted and misused pills.
Aug 27th, 2019
Update: DEA Plans to Expand Marijuana Research
Update: DEA Plans to Expand Marijuana Research
“DEA anticipates that registering additional qualified marijuana growers will increase the variety of marijuana available for these purposes,” said DOJ announcement.
Aug 26th, 2019