Other new indications include:
- Lisdexamfetamine dimesylate (Vyvanse) once-daily prodrug of dexamphetamine has been FDA approved for the treatment of attention deficit/hyperactivity disorder (ADHD) in adults;
- Olopatadine hydrochloride (available as the ocular product Patanol) is now available as a nasal spray (Patanase). It was FDA approved for treatment of the symptoms of seasonal allergic rhinitis in patients age 12 or older;
- Quetiapine (Seroquel) has been FDA approved for maintenance treatment in patients with bipolar I disorder. Quetiapine was already approved for the treatment of schizophrenia and depressive or manic episodes; and
- Risedronate sodium 150 mg tablets (Actonel) have been FDA approved as a once-monthly dose to treat postmenopausal osteoporosis.
Varicella zoster vaccine, live, attenuated (Zostavax): The Centers for Disease Control and Prevention recommends that all adults age 60 or older be vaccinated against herpes zoster with this new vaccine. The recommendation includes patients with a prior shingles episode and those with chronic medical conditions.
Zoster vaccination is not indicated to treat acute zoster, to prevent people with acute zoster from developing post-herpetic neuralgia (PHN), or to treat ongoing PHN. Before administering zoster vaccine, patients do not need to be asked about their history of varicella (chickenpox) or to have varicella immunity testing. It is administered as a single subcutaneous 0.65 mL dose in the deltoid region of the arm. A booster dose is not licensed for the vaccine.
Medication Error Warning
The Institute for Safe Medication Practices (ISMP) has described increased reports of mixups between U-100 and U-500 insulin. These errors can result in dangerous hyperglycemia or hypoglycemia. Mistakes have occurred when prescribers accidentally selected U-500 regular insulin (R) from computer order entry screens instead of U-100.
Potential reasons for this error:
- The two dosage forms appear one line apart on the screen, making it easy to select the wrong one;
- Depending on the screen size, you may only see the first few words of the product listing, so the drug concentration may not be visible;
- Since use of U-500 insulin is uncommon, you may assume the only listed R insulin is U-100 and not look for the drug’s concentration.
ISMP suggests that use of U-500 insulin has increased due to the obesity epidemic, use in insulin pumps, and tight glucose control protocols in the hospital. ISMP says the major suppliers of these computer systems have agreed to add the word “concentrated” on their selection screens, after “insulin” and before U-500, which should help solve the problem.
The acquired immunodeficiency syndrome (AIDS) drugs abacavir (Ziagen) and didanosine (Videx) are being evaluated by the FDA for a possible link to increased risk of myocardial infarction (MI). This is related to the analyses of data collected from “The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study,” which is a large, international observational study of 33,347 HIV-1 infected patients evaluating short- and long-term adverse effects of anti-HIV treatments. The excess risk of MI in patients taking these agents appeared to be greater in patients with other heart disease risk factors. This is an ongoing review.
Meanwhile, the anemia drugs darbepoetin alfa (Aranesp) and epoetin alfa (Epogen/Procrit) have received a boxed warning regarding increased mortality and/or more rapid tumor progression in patients with cancer that are receiving these agents. The warnings section of the package labeling also was updated with additional study information.
Becaplermin gel (Regranex) is a recombinant form of human platelet-derived growth factor FDA approved for treating lower-extremity diabetic neuropathic ulcers. The FDA is evaluating the possibility of an increased cancer risk in diabetic patients who apply becaplermin gel directly to foot/leg ulcers. A recent study involving patients with no previous history of cancer had a greater risk of dying from cancer if they were prescribed becaplermin three or more times. The FDA believes there may be evidence of an increased cancer death risk in patients who had repeated becaplermin treatments.