Europe, US, Japan: The recall round-up

By Fiona BARRY contact

- Last updated on GMT

Related tags: Pharmacology, Allergan

Allergan has begun a voluntary recall of several eye treatments
Allergan has begun a voluntary recall of several eye treatments
Product problems for Allergan and Danish Leo Pharma, plus the Japanese regulator reviews a Bristol-Myers Squibb mAb.

Allergan recall

Irish drugmaker Allergan has recalled several lots of eye ointment because of visible particulates which have caused eye swelling and blurry vision.

Refresh Lacri-Lube 3.5g and 7g for dry eye, Refresh PM 3.5g for dry eye, fluorometholone ophthalmic ointment 0.1% 3.5g, and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment) 3.5g are affected.

Allergan said it chose to trigger a recall based on “a small number​” of customer complaints about small black particles in the ointments. The specks come from broken parts of the cap which can fall into the product’s aluminium tube when unscrewed.

Patients reported adverse events including foreign body in eye, eye irritation, discomfort and pain, product contamination, superficial injury to the eye, eye swelling and blurry vision.

FDA warning for Picato

The US FDA has issued a warning about Picato, a dermatological treatment made by private Danish multinational Leo Pharma. The regulator received reports of cases involving severe eye injuries and skin reactions associated with the gel (ingenol mebutate).

Instructions for Picato limit the length of time patients may use the drug and the size of the skin area to which they apply it. Users must also avoid placing the gel near the mouth, lips, and eyes. The packaging insert warns against accidental transfer of gel from the hands even after washing has occurred, for instance when applying make-up or inserting contact lenses.

But the FDA said some of the adverse event reports came after the usage rules were not followed. The agency will now require Leo Pharma to change the label to expand its safety warning and provide more instructions on applying the product.

Picato is used to treat actinic keratosis, scaly red or yellow skin lesions.

Japan investigates mAb

The Japanese regulator PMDA (Pharmaceutical and Medical Devices Agency) is reviewing several drugs because of an accumulation of adverse drug reaction reports or early postmarketing phase vigilance reports.

The drugs under evaluation are:

  • The monoclonal antibody nivolumab​ (owned by Bristol-Myers Squibb), due to reports of excessive immunisation reaction, myasthenia gravis, myositis, colitis, and severe diarrhoea;
  • Diabetes drugs ipragliflozin L-proline​, dapagliflozin propylene glycolate hydrate​, tofogliflozin hydrate​, luseogliflozin hydrate​, canagliflozin hydrate​, and empagliflozin​, because of ketoacidosis and sepsis reports;
  • Hepatitis C drugs daclatasvir hydrochloride​ and asunaprevir​, after thrombocytopenia reports;
  • Antibiotic azithromycin hydrate​, following drug-induced hypersensitivity syndrome;
  • Multiple sclerosis immune therapy fingolimod hydrochloride​, for progressive multifocal leukoencephalopathy concernsa; and
  • Parkinson’s and shingles treatment amantadine hydrochloride​ because of Rhabdomyolysis ADRs.

PMDA said it may change the precautions section of the drug labels after it completes its reviews.

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