Medication Monitor

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  • August 3, 2018

    FDA is warning that the antibiotic azithromycin should not be given long term to prevent an inflammatory lung condition known as bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. 

    Bronchiolitis obliterans syndrome is caused by inflammation and scarring in the airways of the lungs, resulting in severe shortness of breath and dry cough. Patients with cancer who undergo stem cell transplants from donors are at risk for bronchiolitis obliterans syndrome.There are no known effective antibiotic treatments that prevent the syndrome, and azithromycin is not approved for this use. It is an FDA-approved antibiotic used to treat many types of infections affecting the lungs, sinuses, skin, and other parts of the body.

    The drug, which has been used for more than 26 years, is sold under the brand names Zithromax and Zmax and as generics by many different drug companies. Pfizer, the manufacturer of brand name azithromycin, is providing a Dear Healthcare Provider letter on this safety issue to health professionals who care for patients undergoing donor stem cell transplants.

    FDA is reviewing additional data and will communicate its conclusions and recommendations when the review is complete. Patients who have had a stem cell transplant should not stop taking azithromycin without first consulting with their health care provider.

  • July 31, 2018

    FDA is moving cesium chloride (CsCl) to the category of bulk drug substances (active pharmaceutical ingredients) that present significant safety risks in compounding. CsCl is a mineral salt that is sometimes taken either orally or by injection by cancer patients who seek alternative treatments; however, no CsCl products have been approved by FDA to treat cancer or other diseases. Use of cesium poses significant safety risks (e.g., heart toxicity) and is potentially associated with death. These events can occur with oral administration and/or injection. 

    FDA intends to take action, such as issuing a warning letter or pursuing a seizure of product or injunction, if it encounters compounding using substances placed in this category. 

    FDA reviewed all adverse events related to CsCl and other cesium salts that were reported to FDA or that were published in medical journals through June 30, 2018. FDA identified 23 reports describing serious adverse events associated with cesium, including heart problems.

    Five reports submitted to FDA and 18 published in the medical literature described patients who experienced adverse events from cesium. Seventeen of those reports were associated with CsCl, compared to 6 with other cesium salts like cesium carbonate. Most patients took cesium to try to treat cancer. The doses described in these cases ranged from 500 mg taken every day to 100 g taken over 11 days. Most reports did not identify where the cesium was obtained. In at least eight of these cases, health professionals measured cesium concentrations in the bodies of cesium users and found measured quantities that were several hundred to thousand-fold higher than normal.

    Reported adverse events included QT prolongation, low potassium, seizures, potentially lethal arrhythmias, fainting, cardiac arrest, and death. QT prolongation was the most frequently reported adverse event. QT prolongation in the presence of low potassium usually improves quickly when potassium is administered, but 9 out of 11 of these patients receiving the potassium treatment either did not respond as well as expected or did not respond at all. Of the remaining two patients, one improved as expected, and one had an unknown response. Three patients were treated with a cesium-binding agent called Prussian Blue and had an improvement in the QT within a few days.

    For others, it took several weeks after the cesium was stopped for their QT prolongation to improve. This is probably because when cesium is taken on an ongoing basis, it leaves the body very gradually and may take from 6 months to 2 years to be eliminated.

    Six deaths were reported with use of cesium. FDA considers two of these deaths to be possibly associated with cesium chloride. The reports for these two deaths described cardiac arrest or arrhythmia occurring during, or within 24 hours of injection, of cesium. Three reports did not describe the cause of death, and one person may have died from advanced cancer and bloodstream infection.

  • July 31, 2018

    FDA is alerting health professionals and patients, as well as veterinarians and animal owners, of Ranier’s Rx Laboratory’s voluntary recall of unexpired compounded drug products intended to be sterile. The recalled products were dispensed between January 17, 2018, and July 10, 2018. See Ranier’s notification for additional information.

    Health professionals and veterinarians should immediately check their medical supplies, quarantine any purportedly sterile drug products, and not administer them to patients. Administration of a nonsterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

    FDA issued a warning letter to Ranier’s Compounding in March 2017 following an inspection. During FDA’s recent follow-up inspection of Ranier’s compounding facility, investigators observed insanitary conditions, including poor sterile production practices, which raised concerns about the company’s ability to ensure the sterility of its drug products.

    On June 6, 2018, FDA recommended that Ranier’s Compounding recall all unexpired human and animal drug products intended to be sterile and to cease sterile operations until it makes adequate corrections at its facility. On June 7, 2018, Ranier’s Pharmacy informed FDA that it agreed to voluntarily recall and cease sterile operations. However, the company has failed to comply with its commitment.

    To date, FDA is not aware of any adverse events associated with the use of products from Ranier’s Compounding. Patients who have received drug products produced by Ranier’s Compounding and have concerns should contact their health care provider.

  • July 17, 2018

    FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood glucose and certain mental health adverse effects. The low blood glucose levels can result in serious problems, including coma, particularly in older people and patients with diabetes who are taking medications to reduce blood glucose levels.

    The agency announced it is making these changes because a recent review found reports of life-threatening low blood glucose adverse effects and reports of additional mental health adverse effects.

    FDA is requiring these updates in the drug labels and to the patient Medication Guides for the entire class of fluoroquinolones (see List of FDA-Approved Fluoroquinolones for Systemic Use). This affects only the fluoroquinolone formulations taken by mouth or given by injection. Blood glucose disturbances, including high blood and low blood glucose levels, are already included as a warning in most fluoroquinolone drug labels; however, FDA is adding that low blood glucose levels (hypoglycemia) can lead to coma.

    Across the fluoroquinolone antibiotic class, a range of mental health adverse effects are already described under Central Nervous System Effects in the Warnings and Precautions section of the drug label, which differed by individual drug. The new label changes will make the mental health adverse effects more prominent and more consistent across the systemic fluoroquinolone drug class.

    The mental health adverse effects to be added to or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities (delirium).

    Patients should tell their health professionals if they are taking a diabetes medicine when their health professional is considering prescribing an antibiotic, and also if they have low blood glucose or symptoms of it while taking a fluoroquinolone. Health professionals may ask patients with diabetes to check their blood glucose levels more often while taking a fluoroquinolone.

    Health professionals should be aware of the potential risk of hypoglycemia sometimes resulting in coma, occurring more frequently in older adults and those with diabetes taking an oral hypoglycemic medicine or insulin. Alert patients of the symptoms of hypoglycemia, carefully monitor blood glucose levels in these patients, and discuss with them how to treat themselves if they have symptoms of hypoglycemia. Inform patients about the risk of psychiatric adverse reactions that can occur after just one dose.

    Stop fluoroquinolone treatment immediately if a patient reports any central nervous system adverse effects, including psychiatric adverse reactions, or blood glucose disturbances ,and switch to a nonfluoroquinolone antibiotic if possible. Stop fluoroquinolone treatment immediately if a patient reports serious adverse effects involving the tendons, muscles, joints, or nerves, and switch to a nonfluoroquinolone antibiotic to complete the patient’s treatment course.

    Health professionals should not prescribe fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (uUTI) because the risks outweigh the benefits in these patients.

  • July 17, 2018

    FDA is alerting health professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

    FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.

    Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product. To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine. If a patient is taking one of the recalled medicines, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.

    Patients should also contact their health professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.

    The companies listed are recalling all lots of nonexpired products that contain the ingredient valsartan supplied by a third party. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company. The supplier has stopped distributing its valsartan API, and FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.

    FDA will continue to investigate this issue and provide additional information when it becomes available.