Medication Monitor



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  • June 25, 2015

    FDA approved a new indication for the antiepileptic drug (AED) perampanel hydrate as adjunctive therapy for primary generalized tonic–clonic (PGTC) seizures in patients with epilepsy 12 years of age and older.  

    Perampanel is a first-in-class, highly selective AMPA receptor antagonist first approved in the United States as adjunctive therapy for partial-onset seizures with or without secondarily generalized seizures in patients aged 12 years and older in 2012.  

    The new indication for PGTC was based on results of a Phase 3 study in 164 patients aged 12 years and older with PGTC seizures despite treatment with one to three AEDs. Patients received perampanel oral tablets, once daily, up to 8 mg/d in the titration period and 8 mg/d during the maintenance period.

    The study showed a statistically significant reduction in PGTC seizure frequency with perampanel compared with placebo (change, –76.5% vs –38.4%; P < .0001).

    In addition, significantly more children responded to perampanel than placebo (64.2% vs 39.5%; P = .0019). Roughly 31% of patients treated with perampanel were free of PGTC seizures, compared with 12% of those treated with placebo during the 13-week maintenance period.

    The most common adverse events associated with perampanel are dizziness, fatigue, headache, somnolence, and irritability.

  • November 11, 2015

    FDA approved cobimetinib to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).

    The new agent works by blocking the activity of an enzyme known as MEK, which is part of a larger signaling pathway. Abnormal activity of signaling pathways can lead to cancer. Cobimetinib prevents or slows cancer cell growth.

    Vemurafenib, marketed in the United States as Zelboraf, is a BRAF inhibitor that affects a different part of the same pathway and was approved in 2011 to treat patients with melanoma that has spread to other parts of the body or cannot be removed by surgery and whose tumors express a gene mutation called BRAF V600E, as detected by an FDA-approved test. Health care providers should confirm the presence of BRAF V600E or V600K mutation in their patients’ tumor specimens using one of the available FDA-approved tests before starting treatment with cobimetinib in combination with vemurafenib.

    Safety and efficacy of cobimetinib taken in combination with vemurafenib were demonstrated in a randomized clinical study of 495 patients with previously untreated, BRAF V600 mutation–positive melanoma that is advanced or cannot be removed by surgery. All study participants received vemurafenib and were then randomly selected to also take either cobimetinib or a placebo.

    On average, patients taking cobimetinib plus vemurafenib experienced a delay in the amount of time it took for their disease to worsen (approximately 12.3 months after starting treatment) compared with approximately 7.2 months after starting treatment for those taking vemurafenib only.

    In addition, patients taking cobimetinib plus vemurafenib lived longer, with approximately 65% of patients alive 17 months after starting treatment compared with half of those taking vemurafenib only. And 70% of those taking cobimetinib plus vemurafenib experienced complete or partial shrinkage of their tumors, compared with 50% among those taking vemurafenib plus placebo. 

    The most common adverse effects of treatment with cobimetinib in combination with vemurafenib are diarrhea, sensitivity to ultraviolet light, nausea, fever, and vomiting.

    Cobimetinib may cause severe adverse effects, including damage to the heart muscle or to other muscles, new skin tumors, eye disease, severe skin rash, liver damage, hemorrhage, and severe skin rash due to increased sensitivity to sunlight. People taking cobimetinib should avoid sun exposure, wear protective clothing, and use a broad-spectrum ultraviolet A/ultraviolet B sunscreen to protect against sunburn. Women taking cobimetinib should use effective contraception, as the medication can cause harm to a developing fetus.

    Cobimetinib was reviewed under the FDA’s priority review program and also received orphan drug designation.

  • December 22, 2015

    FDA expanded the approval of pembrolizumab for the initial treatment of patients with unresectable or metastatic melanoma.

    In 2014 pembrolizumab received accelerated approval based on a clinically meaningful, durable objective response rate in patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Two new clinical trials verified the clinical benefit of the drug.  

    The recommended dose and schedule for pembrolizumab is 2 mg/kg Q3W administered as an I.V. infusion every 3 weeks until disease progression or unacceptable toxicity.

  • December 2, 2015

    FDA is alerting health professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of cholecalciferol (Vitamin D3), distributed nationwide by Glades Drugs in Pahokee, Florida. FDA has received reports of several adverse events potentially associated with these compounded capsules.

    Consumption of this product may result in vitamin D toxicity, which may be severe and lead to life-threatening outcomes if left untreated. Patients experiencing adverse effects from high Vitamin D levels may not initially show symptoms. Therefore, patients who have received these compounded capsules should stop taking this medication and immediately seek medical attention. 

    Symptoms of short-term vitamin D toxicity are due to high calcium levels and include confusion, increased urination, increased thirst, loss of appetite, vomiting, and muscle weakness. Acute hypercalcemia may intensify tendencies for heart arrhythmias and seizures and may increase the effects of certain heart drugs. Long-term toxicity may cause kidney failure, increase in calcium deposits in the blood and soft tissue, bone demineralization, and pain. Patients with conditions such as liver disease or chronic kidney failure may be at increased risk for developing vitamin D toxicity.

    Health care providers should quarantine and return any products subject to this recall to the company at Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476. Glades Drugs sent recall letters to patients, attempted to contact them by phone, and called prescribing physicians.

  • November 18, 2015

    Rare cases of underactive thyroid have been reported in infants following the use of iodinated contrast media (ICM) products for X-rays and other medical imaging procedures.

    In all of the reported cases, the infants were either premature or had other serious underlying medical conditions. According to FDA, available evidence shows that this rare occurrence is usually temporary and resolves without treatment or any lasting effects.

    A search of the FDA Adverse Event Reporting System (FAERS) database identified 10 cases of underactive thyroid reported between 1969 and early 2012 in infants younger than 4 months who received ICM. FAERS includes only reports submitted to FDA, so there may be additional cases about which FDA is unaware.

    Several of these infants also received a topical iodine product in addition to ICM that is no longer recommended for young infants, and that may have contributed to their underactive thyroids. All of the infants were diagnosed with underactive thyroid within 1 month of receiving ICM. Some infants were treated and improved while others improved without treatment.

    FDA has approved changes to the labels of all ICM products to include information about these cases. The agency is also requiring the manufacturers to conduct studies to determine how often underactive thyroid occurs with ICM use, how long this temporary condition lasts, and if treatment is needed.

    Health professionals should continue to follow the label recommendations for ICM products and continue to use their clinical judgment to determine if testing for underactive thyroid is necessary.

    FDA will continue to evaluate this safety issue and update the public when additional information is available. 

    FDA urges health professionals and parents/caregivers to report adverse effects involving ICM to the FDA MedWatch program.

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