American Psychiatric Association

October 11, 2019 | Editorial Board | View Online | Psychiatric News

In This Issue



FDA Approves New Loperamide Packaging

Last month the Food and Drug Administration (FDA) announced new package sizes and types for over-the-counter (OTC) loperamide, including Imodium A-D, Imodium Multi-Symptom Relief, and Be Health Loperamide HCl Capsules. The FDA had received reports of serious heart problems and death in people who intentionally misused loperamide by taking high doses of the drug. Research suggests that some people who have opioid use disorder misuse loperamide to prevent or treat symptoms of withdrawal, and some may take massive doses to get high.

The new requirements limit each carton to no more than 48 mg of loperamide and mandate unit-dose blister packaging. The maximum approved dose of OTC loperamide is 8 mg/day. For prescription use, the maximum approved dose is 16 mg/per day.

FDA Panel Recommends Approval for OTC Nicotine Mouth Spray

Also last month, the FDA’s Nonprescription Drugs Advisory Committee narrowly voted in favor of approval of GlaxoSmithKline’s OTC nicotine mouth spray to aid smoking cessation in people aged 18 years and older. Although the FDA is not obligated to follow the committee’s recommendations, the agency usually does so. The spray is marketed in 45 countries.

Each spray delivers 1 mg of nicotine. Users would take up to four sprays per hour and a maximum of 64 sprays per day when they get the urge to smoke.

The committee’s recommendation was based on the results of eight clinical trials, including two multicenter phase 3 studies. The studies compared smoking abstinence in participants who used the spray with those who received a placebo and showed a statistically significant treatment difference between the two groups from week 2 to week 6. The results were not particularly strong (the number needed to treat was 40, meaning 40 smokers would need to be treated with 1 mg of the spray instead of placebo for one more smoker in the treatment group compared with the placebo group to refrain from smoking during those weeks). At the end of 26 weeks, only 3.4% of patients in the treatment group had quit smoking, but 79% kept using the product, suggesting participants continued to use cigarettes along with the spray.



Beck and colleagues have proposed that people with depression are prone to cognitive distortions in three major areas—self, world, and future (i.e., the “negative cognitive triad”). Which of the following dysphoric perspectives deriving from cognitive distortions about the world has been found to be highly associated with suicide risk?

A. Pessimism.

B. Suspiciousness.

C. Hopelessness.

D. Excessive guilt.

E. Self-criticism.

Click Here to Answer


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