Medication Monitor

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  • August 21, 2019

    FDA is warning consumers not to purchase or drink Miracle Mineral Solution products sold online as a remedy for autism, cancer, HIV/AIDS, hepatitis and flu, among other conditions. The solution, when mixed, develops into a dangerous bleach that has caused serious and potentially life-threatening adverse effects.

    Since 2010, FDA has warned consumers about the dangers of Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide Protocol, Water Purification Solution, and similar products. FDA recently received new reports of people experiencing severe vomiting, severe diarrhea, life-threatening low blood pressure caused by dehydration, and acute liver failure after drinking these products.

    FDA is not aware of any scientific evidence supporting the safety or effectiveness of MMS products, despite claims that the solution is an antimicrobial, antiviral, and antibacterial, and the products are approved by FDA for any use.

    Websites selling MMS describe the product as a liquid that is 28% sodium chlorite in distilled water. Product directions instruct consumers to mix the sodium chlorite solution with citric acid—such as lemon or lime juice—or another acid before drinking. In many instances, the sodium chlorite is sold with a citric acid “activator.” When the acid is added, the mixture becomes chlorine dioxide, a powerful bleaching agent.

    Consumers who have experienced an adverse health effect after ingesting this product should seek immediate medical attention. Anyone who has experienced an adverse health effect that may be related to MMS should report it through the FDA’s MedWatch Safety Information program as soon as possible at 800-FDA-1088 or

  • August 21, 2019

    Pfizer is voluntarily recalling eletriptan hydrobromide 40-mg tablets, lots AR5407 and CD4565, to the patient level because these product lots may not meet Pfizer’s in-house microbiological specification for the potential presence of Genus Pseudomonas and Burkholderia.

    Individuals who consume oral products contaminated with microorganisms are at risk of bacterial dissemination from the gut to the bloodstream, potentially resulting in serious, life-threatening infections. In addition, there is risk of temporary GI distress without serious infection. For the general population these risks are low; for certain vulnerable patient populations (such as patients with compromised immune systems, cystic fibrosis, and chronic granulomatous disease), there may be the potential for serious adverse events, including life-threatening infections. 

    The 40-mg tablets are packaged in cartons. The affected lots were distributed nationwide to wholesalers, retailers, hospitals, and health care providers in the United States and Puerto Rico from June 2019 to July 2019.

    To date, Pfizer has not received any customer complaints or reports of adverse events related to this issue.

  • August 21, 2019

    On August 15, Harmony Biosciences announced FDA approval of pitolisant for treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. It is the first treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by DEA.

    WAKIX, a first-in-class medication, is a selective histamine 3 (H₃) receptor antagonist/inverse agonist that works through a novel mechanism of action to increase the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain. The drug is administered orally once daily in the morning upon wakening.

    Efficacy was evaluated in two multicenter, randomized, double-blind, placebo-controlled studies, HARMONY 1 and HARMONY 1bis. These studies included a total of 261 patients who were randomized to receive pitolisant, placebo, or active control; these patients had a median age of 37 (HARMONY 1) and 40 (HARMONY 1bis). Treatment duration was 8 weeks, with a 3-week dose titration phase followed by a 5-week stable dose phase; 75% to 80% of the patients in these studies had a history of cataplexy.

    In both studies, pitolisant demonstrated a statistically significant improvement in EDS as measured by the Epworth Sleepiness Scale (ESS) score. In the placebo-controlled trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (occurring in ≥5% of patients and at twice the rate of placebo) were insomnia, nausea, and anxiety.

  • August 21, 2019

    On August 16, AbbVie announced FDA approval of upadacitinib, a 15-mg, once-daily oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).

    Approval was supported by data from the SELECT program, one of the largest registrational Phase III programs in RA, with approximately 4,400 patients evaluated across all treatment arms in five studies. The studies include assessments of efficacy, safety, and tolerability across a variety of RA patients, including those who failed or were intolerant to biologic disease-modifying antirheumatic drugs and who were naive or inadequate responders to methotrexate. Upadacitinib is not indicated for methotrexate-naive patients.

    Across the SELECT Phase III studies, upadacitinib met all primary and ranked secondary endpoints.

    The recommended dosage is 15 mg taken once a day with or without food.

    The most common adverse effects include upper respiratory tract infections (common cold, sinus infections), nausea, cough, and pyrexia. Patients treated with the drug are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include tuberculosis and invasive fungal, bacterial, viral, and other infections caused by opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. 

    Lymphoma and other malignancies have been observed in patients treated with upadacitinib. Thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated with JAK inhibitors used to treat inflammatory conditions. Patients treated also may be at risk for other serious adverse reactions, including GI perforations, neutropenia, lymphopenia, anemia, lipid elevations, liver enzyme elevations, and embryo-fetal toxicity. 

  • August 21, 2019

    On August 19, FDA approved lefamulin to treat adults with community-acquired bacterial pneumonia. According to CDC data, each year in the United States about 1 million people are hospitalized with community-acquired pneumonia, and 50,000 people die from the disease.

    Lefamulin's safety and efficacy, taken either orally or intravenously, was evaluated in two clinical trials with 1,289 patients who had CABP. Treatment with lefamulin was compared with treatment using another antibiotic, moxifloxacin, with or without linezolid. The trials showed that patients treated with lefamulin had similar rates of clinical success as those treated with moxifloxacin with or without linezolid. 

    The most common adverse reactions reported in patients taking lefamulin included diarrhea, nausea, injection-site reactions, elevated liver enzymes, and vomiting.

    Lefamulin may cause prolonged QT interval. Patients with prolonged QT interval, certain arrhythmias, receiving antiarrhythmic agents for certain irregular heart rhythms, or receiving other drugs that prolong the QT interval should avoid lefamulin. In addition, patients should not use the drug if they have a known hypersensitivity to lefamulin (or any of its components) or to any other members of the pleuromutilin antibiotic class.

    Pregnant women and women who could become pregnant should be advised of the potential risks to a fetus. Women who could become pregnant should be advised to use effective contraception during treatment and for 2 days after the final dose.