FDA Alerts
Anti-Seizure Rx Potiga Linked to Retinal Abnormalities and Blue Skin Discoloration
The US Food and Drug Administration (FDA) is warning the public that the anti-seizure medication Potiga (ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina.
FDA does not currently know if these changes are reversible. All patients taking Potiga should have a baseline eye exam, followed by periodic eye exams.
Pigment changes in the retina have the potential to cause serious eye disease with loss of vision. It is not yet known whether the retinal pigment changes caused by Potiga lead to visual impairment, although several pa...
FDA Launches Partnership to Protect Against Counterfeit Anti-Malarial Medicines
The US Food and Drug Administration today announced a public-private partnership to help identify counterfeit or substandard anti-malarial medicines, including falsified products, with the deployment of the FDA-developed Counterfeit Detection Device, called CD-3.
FDA Announces Recall by Balanced Solutions Compounding Pharmacy
Balanced Solutions Compounding Pharmacy (Balanced Solutions), a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, Fla., is voluntarily recalling all lots of its sterile non-expired drug products due to a lack of sterility assurance and concerns with product quality controls.
FDA Issues Alert for ApotheCure, Inc. and NuVision Pharmacy
The US Food and Drug Administration is alerting healthcare providers, hospital supply managers, and pharmacists that sterile drug products made by ApotheCure, Inc. and sterile lyophilized (freeze-dried powder) drug products made by NuVision Pharmacy were produced under conditions that could create a high potential for contamination.
These products should not be administered to patients.
Sterile drug products that are contaminated place patients at risk of serious infection. The FDA advises healthcare providers and hospital staff to immediately check their medical supplies and quarant...
FDA approves abuse-deterrent labeling for OxyContin
The US Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).
Additionally, because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyCont...
Stimulant Potentially Dangerous to Health, FDA Warns
The Food and Drug Administration (FDA) is using all available tools at its disposal to ensure that dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers in the marketplace.
Rich Products Corporation Recalls Products for E. Coli Risk
Rich Products Corporation of Buffalo, New York, has announced a voluntary recall of certain Farm Rich ® and Market Day ® products.
FDA Approves First Botulism Antitoxin
The US Food and Drug Administration announced today that it has approved Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) to treat patients showing signs of botulism following documented or suspected exposure to botulinum neurotoxin.
FDA Issues Proposal to Improve the Quality of Automated External Defibrillators
The US Food and Drug Administration today issued a proposed order aimed at helping manufacturers improve the quality and reliability of automated external defibrillators (AEDs).
FDA Alerts Healthcare Providers and Patients of Nationwide Recall by Specialty Pharmacy
The US Food and Drug Administration is alerting healthcare providers and patients of a voluntary recall of all lots of sterile products produced and distributed by Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, Ga.