Medicolegal Issues

Market Watch


 

Discontinued Products

  • Amoxicillin powder for oral suspension and pediatric drops for oral suspension1
  • Amoxicillin powder for oral suspension (Amoxil brand usually for adults), 250mg/5mL (100mL and 150mL sizes)2
  • Insulin isophane suspension (Humulin 50/50), due to limited use.3 Current patient demand and existing inventory note product availability through April 2010. There are about 3,000 patients in the U.S. who will be affected by this action.
  • Phenytoin 30 mg (Dilantin Kapseals brand) are being reformulated in a new, extended-release formulation, but Kapseals will be discontinued.4

New Generics

  • Tacrolimus (generic Prograf) capsules5

New Drugs, Indications, and Dosage Forms

  • Asenapine tablets (Saphris) have been approved by the Food and Drug Administration (FDA) to treat adults with schizophrenia and bipolar I disorder. The most common adverse effects in trials were akathisia, oral hypoesthesia, and somnolence. The most common adverse effects that were reported in the bipolar disorder trials were somnolence, dizziness, movement disorders other than akathisia, and weight gain.6
  • Colchicine 0.6 mg tablets (Colcrys) have been approved by the FDA to treat gout flares and familial Mediterranean fever.7 Colchicine has been used for many years but has not received FDA approval until recently. The FDA is re-evaluating some older drugs and drug classes. For example, the pancrelipase products fall under a similar ruling. Now that colchicine is approved, the manufacturer has shown that it meets modern standards for safety, effectiveness, quality, and labeling. Historically, physicians have administered colchicine hourly to treat acute gout flares until symptoms subsided or the patient developed adverse gastrointestinal symptoms. A dosing study determined that one 1.2-mg dose of this formulation followed by 0.6 mg one hour later was as effective as hourly dosing in patients without renal or hepatic dysfunction. This two-dose regimen was less toxic than prior dosing regimens and, therefore, it received the FDA’s approval.8
  • Fentanyl buccal soluble film (Onsolis) has been approved by the FDA as an opioid for managing breakthrough cancer pain in patients 18 years and older who already are receiving and are tolerant to opioid therapy.9 It is available in 200-, 400-, 600-, 800- and 1,200-mcg strengths. A Risk Evaluation and Mitigation Strategies (REMS) will be available with dispensing.
  • Insulin aspart injection (NovoLog) has undergone a label change. NovoLog can now be used in an insulin pump for up to six days. The infusion set should be changed at least every three days. The updated label includes information about discarding the drug if temperatures exceed 37oC (98.6oF).10
  • Interferon beta-1b injection (Extavia): A new brand of interferon has been approved by the FDA for treating relapsing forms of multiple sclerosis (MS), as well as for patients who have experienced a first clinical episode of MS with magnetic resonance imaging (MRI) features consistent of the disease.11
  • Morphine/naltrexone capsules (Embeda), a long-acting opioid designed to reduce drug euphoria, have been approved by the FDA to treat moderate to severe chronic pain. It was developed with the abuse-deterrent drug naltrexone, which reduces euphoria when crushed or chewed.12
  • Pitavastatin 4 mg (Livalo) has been approved by the FDA to treat hypercholesterolemia and combined dyslipidemia.13 It’s a potent statin with a new base structure. Additionally, it is only minimally metabolized by the cytochrome P450 (CYP) pathway. It will be available in early 2010 in 1-, 2- and 4-mg strengths. Only time will tell whether this is truly a benefit for this new agent.
  • Saxagliptin (Onglyza), a new oral dipeptidyl peptidase-4 (DPP-4) inhibitor, has been approved by the FDA to treat Type 2 diabetes mellitus as an adjunct to diet and exercise.14 It is administered once daily at a starting dose of 2.5 mg or 5 mg, without regard to meal.15 The lower dose is recommended in patients with moderate to severe renal impairment or end-stage renal disease (CrCL < 50 mL/min). The lower dose (2.5 mg) also is recommended for patients taking strong CYP3A4/5 inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, or telithromycin). The most common adverse effects in clinical trials were respiratory tract infection, urinary tract infection, and headache.

Pipeline

  • Roflumilast (Daxas), a phosphodiesterase 4 enzyme inhibitor, has been submitted to the FDA. It is a once-daily oral treatment for patients with symptomatic chronic obstructive pulmonary disease (COPD).16
  • Tocilizumab (Actemra), an interleukin-6 receptor-inhibiting monoclonal antibody to treat rheumatoid arthritis (RA), has been approved for use in Europe. Its manufacturer has announced that the FDA has accepted its reapplication for treating moderate to severe RA. It is available in Japan for treating RA, juvenile idiopathic arthritis, and Castleman’s disease.17
  • TZP-102, an investigational oral prokinetic agent for treating diabetic gastroparesis, has received FDA fast-track status. A multinational study is under way for this ghrelin receptor agonist.18 TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

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