View the Expanded Table: Some Drugs for Chronic Idiopathic Constipation

Miudella (Sebela), a copper intrauterine device (IUD), has been approved by the FDA for prevention of pregnancy for up to 3 years. Miudella is the second copper IUD to be approved in the US; ParaGard, which contains more copper and is approved for up to 10 years of use, was approved in 1984. Four hormonal IUDs (Mirena, Liletta, Skyla, Kyleena) that release the progestin levonorgestrel are also available for pregnancy prevention (see Table 2).

Eletriptan hydrobromide (Relpax Pfizer) is now available in the US for oral treatment of migraine headache in adults. It is the seventh serotonin 5-HT1B/1D-receptor agonist (triptan) to be approved by the FDA for this indication. This review describes the pharmacokinetics, adverse effects, drug interactions and recommended dosage of eletriptan. Clinical trials comparing the new drug to placebo and to sumatriptan are presented. A dosage and cost table for all the triptans available in the US is also included. The review concludes with an overall assessment of eletriptan's efficacy and...

The nonsteroidal anti-inflammatory drug (NSAID) diclofenac, has been approved by the FDA in a 1% topical gel formulation (Voltaren Gel - Endo) for treatment of osteoarthritis (OA). A 3% topical diclofenac gel (Solaraze) is currently approved for treatment of actinic keratoses, but not for topical use on joints. No other topical NSAIDs are approved by the FDA for OA. A diclofenac patch (Flector) was recently approved by the FDA for treatment of pain due to minor strains, sprains and contusions.

The FDA has approved loteprednol etabonate ophthalmic suspension 0.25% (Eysuvis – Kala) for short-term treatment (≤2 weeks) of dry eye disease. It is the first ocular corticosteroid to be approved for this indication. Other formulations of loteprednol are approved for treatment of steroid-responsive ocular inflammatory conditions, inflammation after ocular surgery, and seasonal allergic conjunctivitis.

The Vibrant orally administered vibrating capsule (Vibrant Gastro), an FDA-cleared medical device, is now available by prescription for treatment of adults with chronic idiopathic constipation (CIC) who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month. It is the first drug-free treatment to be authorized by the FDA for this indication.

Duloxetine hydrochloride (Cymbalta - Lilly), a selective serotonin and norepinephrine reuptake inhibitor (SNRI), has been approved by the FDA for treatment of major depressive disorder in adults, and more recently for diabetic peripheral neuropathy as well. The Medical Letter will review its role in diabetic neuropathy in a future issue.

An FDA panel has recommended that stronger warnings about hepatotoxicity be added to the labeling for acetaminophen (www.fda.gov, search "acetaminophen hepatotoxicity").

Concerns have surfaced again at the FDA and in the media about the safety of acetaminophen and the multiplicity of products on the market in the US that contain various amounts of it.

Many commonly used drugs can interfere with sexual function in both men and women, causing loss of libido, interfering with erection or ejaculation in men, and delaying or preventing orgasm in women. Drug-related effects on sexual function may be difficult to distinguish from the effects of depression or disease, but most are reversible when drug use is stopped and sometimes when dosage is decreased. Since many patients are reluctant to talk about sexual difficulties, physicians may wish to ask about the possibility of drug-induced sexual dysfunction, particularly when they have...