Department: Medication Update
New drug approved for traveler's diarrhea
The FDA approved oral rifamycin (Aemcolo), an antibacterial indicated for the treatment of adults with traveler's diarrhea caused by noninvasive strains of Escherichia coli (E. coli) not complicated by fever or blood in the stool. Traveler's diarrhea is caused by a variety of pathogens, most commonly bacteria found in food and water, and affects 10% to 40% of travelers worldwide each year.
In a study of 264 adults, rifamycin significantly reduced traveler's diarrhea symptoms compared with placebo. The safety of rifamycin, taken orally over 3 or 4 days, was evaluated in 619 adults with traveler's diarrhea in two controlled clinical trials. The most common adverse reactions associated with rifamycin were headache and constipation.
Rifamycin is a product of Cosmo Technologies, Ltd.
EpiPen Autoinjector may not slide out of tube easily
Pfizer and Mylan have notified healthcare providers in a letter that in a small number of cases, some EpiPen 0.3 mg and EpiPen Jr 0.15 mg autoinjectors and their authorized generic versions may not easily slide out of their carrier tube, which could delay or potentially prevent use of the device during an emergency. The issue is with the device label rather than with the device itself or the epinephrine it delivers.
According to Pfizer and Mylan, in a small number of cases, labels were not fully adhered to the surface of the autoinjector such that they may have become stuck to the inside of the carrier tube. “The probability of this is very low (approximately 1 auto injector out of every 14,286 (0.007%),” according to Pfizer and Mylan. “Although these are rare instances, delay in administration of the EpiPen, EpiPen Jr, and the authorized generic versions of these strengths has a possibility of being associated with progression to a more severe allergic reaction.”
The root cause of this issue has been identified and corrective, and preventive actions are in place. The products potentially affected include:
- EpiPen 0.3 mg (EpiPen NDC 49502-500-02; Authorized Generic NDC 49502-102-02) products with a labeled expiration date on the device and carton between June 2018 and February 2020.
- EpiPen Jr 0.15 mg (EpiPen Jr NDC 49502-501-02; Authorized Generic NDC 49502-101-02) products with a labeled expiration date on the device and carton between October 2018 and October 2019.
The company recommends ensuring that the product can be easily removed from the carrier tube prior to dispensing. If an autoinjector does not readily slide out of its carrier tube, or the label is not fully adhered to the autoinjector, the autoinjector should not be dispensed. Additionally, when the product is about to be dispensed, patients should be counseled to confirm that their autoinjector can be easily removed from the carrier tube prior to actual use. Patients should also be instructed that the autoinjector can still be used when the drug is returned to the carrier tube after inspection.
Special handling instructions for healthcare providers were issued by Mylan and are available online at www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM624893.pdf.
Once-daily COPD drug approved
The FDA approved revefenacin (Yupelri), an inhaled solution, for the maintenance treatment of adults with chronic obstructive pulmonary disease (COPD). Revefenacin is a long-acting muscarinic antagonist and is the first and only once-daily nebulized bronchodilator approved for COPD treatment. Revefenacin is the product of Theravance Biopharma and Mylan.
Revefenacin was evaluated in two phase III efficacy trials involving 1,229 patients with COPD. The drug demonstrated significant and clinically meaningful improvements compared with placebo in trough-forced expiratory volume in 1 second (FEV1) and in overall treatment effect on trough FEV1 after 12 weeks of dosing. Revefenacin was well tolerated in the studies with no new safety issues reported. The most commonly reported adverse reactions were cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain.
Revefenacin should not be used in acutely deteriorating COPD or to treat acute symptoms, and its use should be discontinued if paradoxical bronchospasm occurs.