Drug Alerts and FDA News
- 02/20/2017 VistaPharm, Inc is recalling more than 12,000 units of Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case, Rx only, according to the US Food and Drug Administration’s (FDA) latest Drug Enforcement Report (February 15, 2017). The recall was initiated on January 18, 2017 due to, 'CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia,' according to the FDA. The affected products were distributed throughout the United States. Known lot numbers include 428700 (Exp. 11/17) and 409500 (Exp. 06/17). On February 2, 2017, the FDA designated the recall a class II, meaning that exposure might cause temporary health problems, but is unlikely to cause injuries of a serious nature.
02/07/2017 Health Canada has published a review that concluded that there may be a link between the use of levetiracetam (Keppra) and the risk of acute kidney injury. The current product information for Keppra informs that cases of acute kidney injury have been reported in patients treated with levetiracetam. Health Canada has requested that the other manufacturers of levetiracetam-containing products also update their product information with the same wording. More information is available here.
01/05/2017 The FDA has issued a new class warning for the use of benzodiazepines concomitantly with opiates. This would include AEDs such as Onfi (clobazam), Klonopin (clonazepam), Ativan (lorazepam), Diastat (rectal diazepam) and others. The warning states, "concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.' Please see the attached prescribing information regarding Onfi (clobazam)." More information here and here. Find Onfi prescribing information here.
- 12/12/2016 Health Canada carried out a safety review after learning that the European Medicines Agency was looking into a potential interaction between levetiracetam and methotrexate. The interaction between the two drugs may lead to higher amount of methotrexate in the blood, which may cause serious side effects. The side effects, which can be fatal, include sudden (acute) kidney failure.
- 11/18/2016 FDA recalls of Clonazepam Tablets, USP, 0.5 mg, a drug used to treat certain seizure and panic disorders. The recall affects certain packages. More information here.
- 11/7/2016 Health Canada has indicated a potential link to respiratory depression—including sedation, somnolence, and loss of consciousness—in patients treated with gabapentin, particularly in patients having lung, kidney, or nervous system diseases that impact breathing, as well as in those that are elderly, or using other drugs that can affect breathing such as opioids, or in those are at higher risk of serious breathing problems. Additional information concerning the risk of respiratory depression has been added to the Warnings and Precautions section of the Canadian product monograph (CPM) for Neurontin (gabapentin). Concomitant use of CNS depressants with gabapentin is also a contributing factor. More information here.
- 10/18/2016 EMA recommends measures to ensure safe use of Keppra oral solution. More information here.
- 10/17/2016 FDA approves Carnexiv - i.v. carbamazepine, marketed by Lundbeck. More information here.
- 10/6/2016 FDA recalls lamotrigine tablets, USP, 150 mg, due to misprinted tablets. The medication (NDC 29300-113-05) was packaged in 500-count bottles. More information here.
- 9/26/2016 Zarontin (ethosuximide) - Defective Capsules Associated with Reduced Efficacy (Increased Frequency of Seizures). More information here.
- 8/31/2016 Levetiracetam may rarely be associated with acute renal failure. Recently, the Ministry of Health, Labour, and Welfare in Japan reported that a patient treated with levetiracetam developed acute renal failure within 90 days of the initiation of the treatment. The condition resolved after discontinuation of levetiracetam. In Japan, the prescribing information for levetiracetam now lists acute renal failure as one of the serious adverse reactions. Currently, no specific monitoring is recommended with levetiracetam, but obtaining baseline renal tests before initiation of levetiracetam and periodically thereafter could be done to assess renal function.
- 8/30/2016 Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards. More information here.
- 8/16/2016 GlaxoSmithKline (GSK) is advising healthcare providers that POTIGA (ezogabine) Tablets, CV, 50mg, 200mg, 300mg and 400mg will no longer be commercially available after June 30, 2017. GSK intends to permanently discontinue the product due to the very limited usage of the medicine and the continued decline in new patient initiation. Discontinuation is not due to efficacy or safety reasons. Read more. [PDF]
- 8/15/2016 In an enforcement letter the week of August 1st, the FDA ordered a recall of divalproex 100 mg delayed release tablets manufactured by Teva, Inc. due to failed specifications. The recall number is D-1449-2016 and code information is Lot #: 02D163, Exp. 9/2017.
- 5/29/2016 A new boxed warning has been added to the prescribing information for ezogabine: "Potiga (ezogabine) can cause retinal abnormalities with funduscopic features similar to those seen in retinal pigment dystrophies, which are known to result in damage to the photoreceptors and vision loss. Macular abnormalities characterized as vitelliform lesions have also been observed. All patients taking Potiga should have baseline and periodic (every 6 months) systematic visual monitoring by an ophthalmic professional. Testing should include visual acuity, dilated fundus photography, and optical coherence tomography." Click here to download. [PDF]
- 4/18/2016 Study in Neurology finds pregbalin may be linked to major birth defects. View the Pubmed citation.
- 4/12/2016 The FDA issues overview, "FDA Regulation of Marijuana: Past Actions, Future Plans." Click here to download. [PDF]
- 4/6/2016 The FDA and the manufacturer updated the prescribing information for Zonegran (zonisamide) to include a warning about Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) also known as multiorgan hypersensitivity. Download the revised prescribing information here. [PDF]
- 2/19/2016 FDA approves Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy. Click here for more information.
- 12/21/2015 Drug interactions between AEDs and antivirals for hepatitis C. Recently, new antivirals (e.g., asunaprevir, daclatasvir, sofosbuvir, telaprevir, vaniprevir) and the endothelin receptor antagonist (macitenta) were approved for the treatment of hepatitis C. AEDs which induce the CYP3A4 isozyme (e.g., phenobarbital and phenytoin) increase the metabolism of antivirals, causing a significant reduction of the serum concentrations of the antivirals and the endothelin receptor antagonist. The antivirals and the endothelin receptor antagonist, with interferon, are necessary to eradicate the hepatitis C virus. Clinicians should be aware of this serious drug-drug interaction to optimize hepatitis C treatment. Providers are advised to consult with a pharmacist or use appropriate drug information resources to check any potential drug-drug interactions between AEDs and hepatitis C treatment agents.
- 12/4/2015 On Dec 4, 2015, the FDA approved updated Prescribing Information (PI) for Oxtellar (oxcarbazepine). Serious, potentially life-threatening, dermatologic reactions such as toxic epidermal necrolysis (TEN) and Stevens Johnson syndrome (SJS) have occurred in adults and children treated with oxcarbazepine. Median time of onset was 19 days. Patients with Human Leukocyte Antigen (HLA) allele B*1502 may be at increased risk. The HLA-B*1502 allele is present in 2-15% of patients from various countries with Han Chinese ancestry. Prior to initiating oxcarbazepine treatment, testing for HLA-B*1502 should be considered in patients of Asian ancestry. Oxcarbazepine should be avoided in patients positive for HLA-B*1502, unless the benefits clearly outweigh the risks. Click here for the prescribing information. [PDF]
- 9/30/2015 On August 28, 2015, the FDA approved updated Prescribing Information (PI) for Tegretol (carbamazepine). Information about the risk of serious dermatologic reactions such as toxic epidermal necrolysis (TEN) and Stevens Johnson syndrome (SJS) are presented. Among patients of Chinese ancestry, there is a strong association of developing SJS/TEN with the HLA-B*1502 gene variant. Prior to initiating Tegretol treatment, testing for HLA-B*1502 should be performed in patients with ancestry in which HLA-B*1502 may be present (many Asian countries). The PI now states Tegretol should not be used in patients positive for HLA-B*1502 unless the benefit clearly outweighs the risks. Please see the full PI for additional information about this, as well as the use carbamazepine with other drugs such as phenytoin which may increase the risk of cutaneous reactions in patients with HLA-B*1502, the risks of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and the risk of SJS/TEN and DRESS among patients of European, Korean, Japanese and other ancestry who carry the HLA-A*3101 allelic variant. Click here for the prescribing information. [PDF]
- 9/28/2015- The FDA and Pfizer issued an updated PI for Neurontin (gabapentin) in September 2015. The update is to section 5.2 of the PI which states "Neurontin can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat and tongue and hypotension requiring emergency treatment. Patients should be instructed to discontinue Neurontin and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema." Click here to download the prescribing information. [PDF]
- 8/28/2015 - FDA approved a monotherapy indication for eslicarbazepine. The indication reads, "Aptiom (eslicarbazepine acetate) is indicated for the treatment of partial-onset seizures as monotherapy or adjunctive therapy." The recommended maintenance dose is 800 mg to 1600 mg once daily, depending on clinical response and tolerability. Click here to download the prescribing information. [PDF]
- 6/19/2015 - FDA approved perampanel (Fycompa) for the adjunctive treatment of Primary Generalized Tonic-Clonic Seizures (PGTCS) in patients age 12 years and older.
- 6/17/2015 - FDA Determines Ezogabine Labeling Adequate to Manage Risks Based on reviews of additional safety reports from patients treated with the anti-seizure drug ezogabine (brand name Potiga), the US Food and Drug Administration has determined that the potential risks of vision loss due to pigment changes in the retina and of skin discoloration can be adequately managed by following the current recommendations in the ezogabine labeling. To further explore any potential long-term consequences of these pigment changes, FDA has required the ezogabine manufacturer, GlaxoSmithKline, to conduct a long-term observational study. The FDA recommends that health care professionals should continue to follow the recommendations provided in the Boxed Warning, FDA’s most serious type of warning, and the Warnings and Precautions and Indications and Usage sections of the labeling.
- 6/16/2015 - The FDA has worked with the manufacturer of fosphenytoin (Cerebyx) to update the prescribing information. Studies in patients of Chinese ancestry have found a strong association between the risk of developing SJS/TEN and the presence of HLA-B*1502, an inherited allelic variant of the HLA B gene, in patients using carbamazepine. Limited evidence suggests that HLA-B*1502 may be a risk factor for the development of SJS/TEN in patients of Asian ancestry taking other antiepileptic drugs associated with SJS/TEN, including phenytoin. Consideration should be given to avoiding CEREBYX as an alternative for carbamazepine patients positive for HLAB*1502.
- 5/22/2015 IV Levetiracetam – Shortage identified May 21, 2015 Earliest anticipated release date: June 2015
- 5/7/2015 IV Valproate Sodium – Shortage identified May 7, 2015 Earliest anticipated release date: Late May 2015
- 4/20/2015 - Blue Cross Blue Shield Association has changed its policy to state that responsive neurostimulation may be considered medically necessary for patients with medication-refractory partial epilepsy who meet certain criteria.
- 3/25/2015 - Depakote PI update - "On March 10th, the FDA and the manufacturer updated the label for divalproex (Depakote) to include new and updated warnings about cytopenias, coagulopathies, and DRESS. The new prescribing information reads in section 5.8, 'Valproate is associated with dose-related thrombocytopenia ... and ... decreases in other cell lines and myelodysplasias. Because of reports of cytopenia, inhibition of secondary phase of platelet aggregation, and abnormal coagulation parameters (e.g., low fibrinogen, coagulation factor deficiencies, acquired VonWillebrand's disease) measurements of complete blood counts and coagulation parameters are recommended before initiating therapy and at periodic intervals.' In addition in section 5.12, the term Multi-organ Hypersensitivity Reaction has been changed to Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and a completely revised description of DRESS and its severity is provided along with recommendations on how to evaluate it and to stop Depakote." The March 2015 PI is attached here and is also available on the FDA website.
- 3/17/2015 - Levetiracetam (Keppra) - The FDA, working with the manufacturer, has updated the prescribing information for levetiracetam (Keppra). New warnings include behavioral abnormalities and psychotic symptoms, somnolence and fatigue, red blood cell and white blood cell count decreases, as well as significant diastolic blood pressure increases in 17% of children aged 1 month to <4 years. Read more.
- 3/11/2015 - The US Food & Drug Administration, working with the manufacturer, has made changes to the prescribing information (PI) for Vimpat with regard to overdoses with the medication. The updated PI contains the wording, 'Following single acute overdoses of 1,000 mg or greater of Vimpat, cardiac conduction disorders and seizures, including generalized tonic-clonic seizures and status epilepticus have been observed.' The updated PI can be found here.