Medication Monitor



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  • February 1, 2016

    FDA has approved elbasvir and grazoprevir with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.

    Safety and efficacy of elbasvir and grazoprevir with or without ribavirin were evaluated in clinical trials of 1,373 participants with chronic HCV genotype 1 or 4 infections with and without cirrhosis. The participants received the combination drug with or without ribavirin once daily for 12 or 16 weeks. The studies were designed to measure whether a participant’s HCV was no longer detected in the blood 12 weeks after finishing treatment (sustained virologic response [SVR]), suggesting a participant’s infection had been cured.

    The overall SVR rates ranged from 94% to 97% in participants infected with genotype 1 and from 97% to 100% in participants infected with genotype 4 across trials for the approved treatment regimens. To maximize SVR rates for patients, the product label provides recommendations on length of treatment with or without ribavirin specifically tailored to the characteristics of the patient and his or her virus. Health professionals should screen genotype 1a–infected patients for certain viral genetic variations before starting treatment with elbasvir and grazoprevir to determine dosage regimen and duration.

    The most common adverse effects of elbasvir and grazoprevir without ribavirin were fatigue, headache, and nausea. The most common adverse effects with ribavirin were anemia and headache.

    The product carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1% of clinical trial participants, generally at or after treatment week 8. Liver-related blood tests should be performed before starting therapy and at certain times during treatment. The agent should not be given to patients with moderate or severe liver impairment.

  • July 13, 2016

    FDA approved lifitegrast ophthalmic solution for the treatment of signs and symptoms of dry eye disease. It is the first medication in a new class of drugs called lymphocyte function–associated antigen 1 (LFA-1) antagonists.

    Dry eye disease includes a group of conditions in which the eye does not produce an adequate volume of tears or when the tears are not of the correct consistency. The chance of experiencing dry eye increases with age, affecting approximately 5% of the adult population aged 30 to 40 years and 10% to 15% of adults older than age 65, and is more common among women.

    When severe and left untreated, this condition can lead to pain, ulcers, or scars on the cornea. Dry eye can make it more difficult to perform some activities, such as using a computer or reading for an extended period of time, and it can decrease tolerance for dry environments, such as the air inside an airplane.

    Safety and efficacy of the solution were assessed in more than 1,000 patients in four separate, randomized, controlled studies. These studies included patients aged 19 to 97 years, of which the majority were female (76%).

    Patients were randomized equally to receive either lifitegrast ophthalmic eyedrops or placebo eyedrops, which were used twice a day for 12 weeks.

    The studies found that groups treated with lifitegrast ophthalmic eyedrops demonstrated more improvement in both the signs and the symptoms of eye dryness than the groups treated with placebo.

    The most common adverse effects included eye irritation, discomfort or blurred vision, and an unusual taste sensation.

    Dry eye disease does not routinely occur in children. Safety and efficacy in pediatric patients below the age of 17 years have not been studied.

  • October 27, 2015

    An FDA safety review has found no clear evidence of an increased risk of heart attacks, stroke, or other cardiovascular events associated with the use of entacapone for the treatment of Parkinson disease. As a result, recommendations for using entacapone and a drug combining entacapone, carbidopa, and levodopa will remain the same in the drug labels.

    FDA alerted patients and health professionals about a possible increased risk for cardiovascular events and death with the combination drug Stalevo in August 2010. This possible safety issue was observed in a clinical trial called the Stalevo Reduction in Dyskinesia Evaluation in Parkinson’s Disease (STRIDE-PD) and in a meta-analysis that combined the cardiovascular-related findings from 15 clinical trials comparing Stalevo to carbidopa/levodopa.

    Carbidopa and levodopa have been used extensively and have not been shown to have an increased cardiovascular risk. FDA was concerned that the entacapone in Stalevo was responsible for these cardiovascular risks because the comparison drugs do not contain this ingredient.

    To better understand the significance of these findings, FDA required the Stalevo manufacturer, Novartis, to study the potential for cardiovascular risk with the entacapone component of the drug. FDA examined the results from this required study and from one additional study and concluded they do not show an increased risk of cardiovascular adverse events with entacapone. The results observed in the original meta-analysis were driven by results of a single study (STRIDE-PD), which was not designed to assess cardiovascular risks. 

    FDA believes that the meta-analysis and STRIDE-PD results are chance findings and do not represent a true increase in risk from use of entacapone.

  • October 14, 2015

    FDA granted accelerated approval for pembrolizumab to treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express the PD-L1 protein. Pembrolizumab is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test (marketed by Dako North America Inc.), the first test designed to detect PD-L1 expression in NSCLC tumors.

    Pembrolizumab targets the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, pembrolizumab may help the body’s immune system fight the cancer cells. In 2014, pembrolizumab was approved to treat patients with advanced melanoma following treatment with ipilimumab, a type of immunotherapy. Another drug, nivolumab (Opdiva—Bristol-Meyers Squibb), also targets the PD-1/PD-L1 pathway and was approved to treat squamous NSCLC in 2015.

    Safety of pembrolizumab was studied in 550 patients with advanced NSCLC. Its most common adverse effects included fatigue, decreased appetite, shortness of breath or impaired breathing, and cough. Pembrolizumab  also has the potential to cause severe adverse effects that result from the immune system effect of the drug (immune-mediated adverse effects).

    Effectiveness of pembrolizumab for this use was demonstrated in a subgroup of 61 patients enrolled within a larger multicenter, open-label, multipart study. The subgroup consisted of patients with advanced NSCLC that progressed following platinum-based chemotherapy or, if appropriate, targeted therapy for certain genetic mutations (ALK or EGFR). This subgroup also had PD-L1 positive tumors, as determined by the results of the 22C3 pharmDx diagnostic test.

    Study participants received pembrolizumab 10 mg/kg every 2 or 3 weeks. The major outcome measure was overall response rate (percentage of patients who experienced complete and partial shrinkage of their tumors). Tumors shrank in 41% of patients treated with pembrolizumab, and the effect lasted between 2.1 and 9.1 months.                                                                                                         

    In the 550 study participants with advanced NSCLC, severe immune-mediated adverse effects occurred involving the lungs, colon, and hormone-producing glands. Other uncommon immune-mediated adverse effects were rash and inflammation of blood vessels.

    Women who are pregnant or breastfeeding should not take pembrolizumab because it may cause harm to a developing fetus or newborn baby. Across clinical studies, a disorder in which the body's immune system attacks part of the peripheral nervous system (Guillain-Barre Syndrome) also occurred.

    FDA granted pembrolizumab breakthrough therapy designation for this indication because Merck demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies. The drug also received priority review status, which is granted to drugs that, at the time the application was submitted, have the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition.

    Pembrolizumab was approved under the agency’s accelerated approval program, which allows the approval of a drug to treat a serious or life-threatening disease on the basis of clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. An improvement in survival or disease-related symptoms in patients being treated with pembrolizumab has not yet been established.

  • May 1, 2018

    FDA warned that use of lamotrigine for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, FDA is requiring a new warning that this risk be added to the prescribing information in the lamotrigine drug labels.

    The immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), typically presents as a persistent fever, usually greater than 101°F. HLH can lead to severe problems with blood cells and organs throughout the body, such as the liver, kidneys, and lungs.

    Lamotrigine is used alone or with other medications to treat seizures in patients aged 2 years and older. It may also be used as maintenance treatment in patients with bipolar disorder.

    Health professionals should be aware that prompt recognition and early treatment is important for improving HLH outcomes and decreasing mortality. Diagnosis is often complicated, as early signs and symptoms such as fever and rash are not specific.

    HLH may also be confused with other serious immune-related adverse reactions. Evaluate patients who develop fever or rash promptly, and discontinue lamotrigine if HLH or another serious immune-related adverse reaction is suspected and an alternative etiology for the signs and symptoms cannot be established.

    Since lamotrigine’s 1994 approval, FDA identified eight cases worldwide of confirmed or suspected HLH associated with the medication in children and adults. This number includes only reports submitted to FDA and found in the medical literature, so there are likely additional cases about FDA is unaware, according to the agency. FDA determined there was reasonable evidence that lamotrigine was the cause of HLH in these eight cases based on the timing of events and order in which they occurred. These patients required hospitalization and received drug and other medical treatments, with one dying.

    A link to the full communication detailing specific information for health professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications.

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