FDA Update
Clarissa Chan, PharmD
Especially during these tough times, people may be having difficulty coping and could seek out medications like benzodiazepines to “fix” their problems. As pharmacists, it is important to be informed of such growing trends and follow FDA’s updates on new findings to better educate patients on safe and effective use of both prescription-only and OTC medications.
Boxed warning update for benzodiazepines
In September, FDA updated the boxed warning and other sections in the prescribing information for the benzodiazepine drug class to improve safe use. Updates to the warnings and precautions, drug abuse and dependence, and patient counseling sections detail the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions.
These updates are also highlighted in patient medication guides to educate patients about these risks.
High Benadryl doses can lead to serious health consequences, even death
FDA released a warning in late September on the use of higher-than-recommended OTC doses of the allergy medication diphenhydramine (Benadryl—Johnson & Johnson). The agency cautioned that taking high doses of the drug can lead to serious cardiac issues, seizures, coma, and even death.
This came to light in news reports on teenagers who were encouraged to post videos of themselves performing the “Benadryl Challenge” on the social media platform TikTok. These reports cited emergency department visits and death resulting from this challenge.
As part of monitoring these incidents and helping the ongoing FDA investigation, pharmacists should counsel patients to use the lowest-effective dose as indicated on Benadryl package labeling. In addition, pharmacists should report any adverse events or effects to FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program or by calling 800-332-1088.
Inconclusive evidence contradicts FDA’s fluoroquinolone warnings
In 2018, FDA issued a safety warning about the possible association of fluoroquinolone antibiotic use with a higher risk of aortic aneurysms and dissections.
But a recently published New England Journal of Medicine Journal Watch article reported that two studies in JAMA Internal Medicine indicated otherwise.
One study compares data from a Taiwan insurance database of 5,400 patients with aortic disease to that of 54,000 control participants with no underlying aortic disease. All of the patients had similar infections in the past 60 days.
The researchers found no difference between use of fluoroquinolones versus other antibiotics and no increased risk of aortic disease.
The second study, which used data from a U.S. claims database, examined outcomes from 280,000 patients who took antibiotics for treatment of pneumonia and 950,000 patients who received oral antibiotic treatment for urinary tract infection (UTI).
The latter study findings showed a small increased risk of aortic disease in patients with pneumonia taking fluoroquinolones (0.03%) versus other antibiotics (0.01%), but yielded no differences in patients with UTI (both antibiotics were <0.01%).
Makena is not effective in reducing preterm birth risks
In early October, FDA’s Center for Drug Evaluation and Research decided to reconsider the availability of the drug hydroxyprogesterone caproate injection (Makena—AMAG Pharmaceuticals) in the U.S. drug market because of postmarket study failure on the effectiveness of its approved use.
In 2011, Makena was originally put on fast track to receive accelerated FDA approval for reducing the risk of preterm birth in women who had a history of idiopathic preterm births.
No drugs currently on the market prevent preterm birth, defined as a baby born before 37 weeks. The health of a premature baby can be greatly compromised, and an effective drug in preventing preterm birth could lead to greater outcomes for these babies overall.
The postmarket study found that Makena had not been shown to reduce the risk of preterm births or improve babies’ overall health.
Risks of NSAIDs in second half of pregnancy
In October, FDA announced that it is requiring changes to the labeling for NSAIDs to caution against their use during the second half of pregnancy (20 weeks gestation or later) because NSAIDs can cause rare but serious kidney damage in the fetus that leads to changes in the amniotic fluid levels and results in pregnancy complications.
Although aspirin has NSAID properties, low-dose aspirin is sometimes needed to treat patients during pregnancy, so care should be taken to monitor patients who are taking aspirin, FDA said.