Medication Monitor

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  • November 30, 2018

    FDA is warning about genetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication's effects has not been determined. These genetic tests might be offered through health care providers or advertised directly to consumers and claim to provide information on how a patient will respond to medications used to treat conditions such as depression, heart conditions, acid reflux, and others. They might claim to predict which medication should be used or that a specific medication may be less effective or have an increased chance of adverse effects compared with other medications due to genetic variations.

    Results from these tests may also indicate that the health care provider can or should change a patient's medication on the basis of these test results. FDA is also aware of software programs that interpret genetic information from a separate source that claim to provide this same type of information. However, sufficient clinical evidence is not currently available for these genetic tests or software programs, and therefore, these claims are not supported for most medications.

    According to the agency, patients and health care providers should not make changes to a patient's medication regimen on the basis of results from genetic tests that claim to predict a patient's response to specific medications, but are not supported by sufficient scientific or clinical evidence to support this use. Doing so may put the patient at risk for potentially serious health consequences.

    There are a limited number of cases for which at least some evidence does exist to support a correlation between a genetic variant and drug levels within the body, and this is described in the labeling of FDA cleared or approved genetic tests and FDA-approved medications. FDA-authorized labels for these medical products may provide general information on how DNA variations may affect the levels of a medication in a person's body, or they may describe how genetic information can be used to determine therapeutic treatment, depending on the available evidence.

    Recommendations for health care providers and laboratories

    • If you are using, or considering using, a genetic test to predict a patient's response to specific medications, be aware that for most medications, the relationship between DNA variations and the medication's effects has not been established. Check the FDA-approved drug label, or the label of the FDA-cleared or approved genetic test for information regarding whether genetic information should be used for determining therapeutic treatment.
    • If a patient brings you a test report from a genetic test offered directly to consumers that claims to predict a person's response to a specific medication, seek information in the FDA-approved drug label regarding whether genetic information should be used for determining therapeutic treatment.
    • Be aware that there are some FDA-approved drug and genetic test labels, and labels of FDA-cleared genetic tests that provide general information about the impact of DNA variations on drug levels, but do not describe how that genetic information can be used for determining therapeutic treatment. These labels are intended to be informational, but do not indicate that there is sufficient evidence to support making treatment decisions based on the information provided by the genetic test.
    • Know that information regarding therapeutic treatment recommendations for patients with certain genetic variations can be found in the warnings (Boxed Warning, or Warnings and Precautions), Indications and usage, Dosage and Administration, or Use in Specific Populations sections of the FDA approved drug labeling, as appropriate.
    • Be aware that most genetic tests that make claims regarding effects of a specific medication have not been evaluated by FDA.

  • November 30, 2018

    FDA is warning that signs and symptoms of a life-threatening adverse effect called differentiation syndrome are not being recognized in patients receiving the acute myeloid leukemia medicine enasidenib. The enasidenib prescribing information and patient Medication Guide already contain a warning about differentiation syndrome. However, the agency said it has become aware of cases of differentiation syndrome not being recognized and patients not receiving the necessary treatment.

    As a result, FDA is alerting health professionals and patients about the need for early recognition and aggressive management of differentiation syndrome to lessen the likelihood of serious illness and death. The agency is continuing to monitor this safety concern.

    Health professionals should describe to patients the symptoms of differentiation syndrome listed in the Medication Guide when starting enasidenib and at follow-up visits, and inform them to call their health professional if such symptoms occur. Differentiation syndrome has occurred as early as 10 days and up to 5 months after starting the medicine. If patients experience unexplained respiratory distress or other symptoms, consider a diagnosis of differentiation syndrome, and treat promptly with oral or I.V. corticosteroids.

    Patients should contact their health professional or go to the nearest hospital emergency department right away if they develop any of the following symptoms of differentiation syndrome while taking enasidenib: fever; cough; shortness of breath; swelling of arms and legs; swelling around the neck, groin, or underarm area; fast weight gain of more than 10 pounds within a week; bone pain; or feeling dizzy or lightheaded.

    Enasidenib was approved in August 2017 to treat patients with acute myeloid leukemia (AML) with a specific genetic mutation called isocitrate dehydrogenase (IDH)-2 whose disease has come back or has not improved after treatment with other chemotherapy medicines. Enasidenib works by blocking several enzymes that promote this abnormal blood cell growth.

    In the clinical trial conducted for enasidenib's approval, at least 14% of patients experienced differentiation syndrome. The manufacturer’s safety report, which included the period of May 1, 2018, to July 31, 2018, reported five cases of death associated with differentiation syndrome in patients taking the drug.

  • November 30, 2018

    FDA is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received alemtuzumab. These problems can lead to permanent disability and even death.

    As a result, the agency has added a new warning about these risks to the prescribing information in the drug label and to the patient Medication Guide. FDA also added the risk of stroke to the existing boxed warning, its most prominent warning.

    Alemtuzumab is also approved under the brand name Campath, which was approved in May 2001 to treat B-cell chronic lymphocytic leukemia (B-CLL). The Campath drug label will also be updated to include these risks in the adverse reactions section under postmarketing experience.

    Patients or their caregivers should seek emergency treatment immediately if the patient experiences signs or symptoms of a stroke or tears in the lining of the head and neck arteries, called arterial dissection, which can include sudden numbness or weakness in the face, arms, or legs, especially if it occurs on only one side of the body; sudden confusion, trouble speaking, or difficulty understanding speech; sudden trouble seeing in one or both eyes; sudden trouble with walking, dizziness, or loss of balance or coordination; and sudden severe headache or neck pain.

    Most patients taking alemtuzumab who developed stroke or tears in the artery linings developed symptoms within 1 day of receiving the drug. One patient reported symptoms that occurred 3 days after treatment.

    Health professionals should advise patients at every alemtuzumab infusion to seek immediate emergency medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection. The diagnosis is often complicated because early symptoms such as headache and neck pain are not specific. Promptly evaluate patients who complain of symptoms consistent with these conditions.

    In the nearly 5 years since FDA approved alemtuzumab in 2014 to treat relapsing forms of MS, the agency has identified 13 worldwide cases of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after the patient received alemtuzumab. This number includes only reports submitted to FDA, so additional cases the agency is unaware of may have occurred. Twelve of these cases reported symptoms within 1 day of receiving the drug.

  • November 27, 2018

    Fresenius Kabi USA is voluntarily recalling 163 lots of sodium chloride injection 0.9%, 10 mL fill in a 10-mL vial; and sodium chloride injection 0.9%, 20 mL fill in a 20-mL vial. The product is being recalled because the stoppers contain natural rubber latex.

    The product insert states that stoppers for both the 10-mL and the 20-mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20-mL vial also state that the stoppers do not contain latex. 

    For the population most at risk, those with a severe allergic reaction to latex, there is probability of an anaphylactic reaction that could result in hospitalization or death.

    To date, Fresenius Kabi USA has not received any reports of adverse events related to this recall. 

    See the tables for a full list of the affected lots, including lot numbers and expiration dates.

  • November 27, 2018

    FDA is alerting patients and health professionals to Mylan's voluntary recall of 15 lots of valsartan-containing products that contain N-nitrosodiethylamine (NDEA).

    Not all Mylan valsartan-containing products distributed in the United States are being recalled. Mylan is recalling only those lots of valsartan-containing products that tested positive for NDEA above the acceptable level. The agency continues to investigate and test all angiotensin II receptor blockers (ARBs) for the presence of NDEA and N-nitrosodimethylamine (NDMA) and is taking swift action when it identifies these impurities that are above acceptable levels.

    FDA has updated lists of valsartan products under recall and valsartan products not under recall.

    In addition, FDA reminds patients taking this medication or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. It also is important to know not all ARBs contain NDMA or NDEA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.

    FDA has also posted questions and answers to assist health professionals and patients.