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FDA updates warnings for fluoroquinolone antibiotics

The FDA is requiring safety labeling changes for fluoroquinolone antibiotics to strengthen the warnings about the risks of mental health adverse reactions and serious blood glucose disturbances by making these warnings more consistent across the labeling for all fluoroquinolone antibiotics taken orally or by injection.


The FDA notes that the fluoroquinolone class is still appropriate in the treatment of serious bacterial infections, such as certain types of bacterial pneumonia, in which the benefits of these drugs outweigh the risks. The agency is committed to keeping the drug's risk information current and comprehensive to ensure that healthcare providers and patients consider risks and benefits to make informed decisions.


The agency notes that across the fluoroquinolone antibiotic class, a range of mental health adverse reactions are already described in the warnings and precautions section of the drug labeling but differ by individual drug. However, the new classwide labeling changes require that the mental health adverse reactions be listed separately from other central nervous system adverse reactions and be consistent across the labeling of all drugs in the fluoroquinolone class.

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The mental health adverse reactions to be included in the labeling across all fluoroquinolones include disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium. Additionally, a recent FDA review found instances of coma related to hypoglycemia in patients receiving fluoroquinolones.


Older adults and those taking oral diabetes agents or insulin may be at increased risk. The blood glucose disturbances subsection of labeling for systemic fluoroquinolones will now be required to explicitly reflect the potential risk of coma with hypoglycemia.


FDA approves first generic epinephrine autoinjector

The FDA approved a generic version of Mylan's EpiPen (0.3 mg) and EpiPen Jr. (0.15 mg) epinephrine autoinjectors for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis) in adults and pediatric patients who weigh more than 33 lb (15 kg).


The FDA's approval of Teva Pharmaceuticals USA's generic epinephrine autoinjector is the first time the agency approved a therapeutic equivalent of the EpiPen. The generic approval will help maintain a constant access to epinephrine for patients with severe allergies and will help protect against potential shortages of the life-saving drug.


The most common adverse reactions associated with epinephrine injection include anxiety, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea, vomiting, headache, and/or respiratory difficulties. Of note, there have been and currently are competitors to EpiPen epinephrine autoinjectors available.


Nighttime ADHD medication approved

Methylphenidate hydrochloride (HCl) (Jornay PM) extended-release capsules for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients 6 years and older is now approved for marketing. Methylphenidate HCl extended-release is a product of Ironshore Pharmaceuticals.


The drug uses a proprietary drug delivery system that consists of two functional film coatings: the first layer delays the initial drug release for up to 10 hours, and the second layer helps control the release rate of the active ingredient throughout the day. Methylphenidate HCl extended-release is intended for dosing in the evening; timing of dosing may be adjusted between 6:30 p.m. and 9:30 p.m. to optimize efficacy and tolerability.

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Methylphenidate HCl extended-release was developed specifically to address the impact of ADHD on early morning routine, often the busiest and most chaotic for families. In two studies supporting the approval, Methylphenidate HCl extended-release was administered to pediatric patients ages 6 to 12 years with ADHD and was shown to improve ADHD manifestations in a classroom setting in the early morning; rating scale results also indicated improvement in ADHD manifestations throughout the day.


Methylphenidate HCl extended-release is a Schedule II controlled substance and is expected to launch in the first half of 2019.