Roweepra XR FDA Alerts
The FDA Alerts below may be specifically about Roweepra XR or relate to a group or class of drugs which include Roweepra XR.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Roweepra XR
Lannett Issues Voluntary Nationwide Recall of Levetiracetam Oral Solution, 100mg/mL Due to Microbial Contamination
December 19, 2019 -- Lannett Company, Inc. today announced that it is voluntarily recalling two (2) lots of Levetiracetam Oral Solution, 100mg/mL to the consumer level due to contamination with Bacillus subtilis. The Bacillus subtilis was identified during an evaluation of a raw material used to manufacture the product.
Risk Statement: Bacillus subtilis is ubiquitous in the environment and although the pathogenic potential has been described as low, serious systemic infections have been reported. The likelihood of the health hazard depends on the degree of microbial contamination, the dose and duration of treatment, and the patient’s underlying conditions. It is possible that a severe infection may occur in immunocompromised patients. Lannett has not received any reports of adverse events related to this recall to date.
Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month and older. It is also indicated for adjunctive therapy of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy and primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy and is packaged in bottles of 16 fluid ounces (one pint) (NDC 54838-548-80). The affected Levetiracetam Oral Solution lots include the following:
|Product||NDC||Lot Number||Expiration Date|
|Levetiracetam Oral Solution 100mg/mL||54838-548-80||2190A||07/2021|
|Levetiracetam Oral Solution 100mg/mL||54838-548-80||2191A||07/2021|
The product can be identified by NDC number and batch numbers provided above. Levetiracetam Oral Solution was distributed nationwide in the USA to wholesalers/distributors.
Lannett is notifying its distributors and customers via email and via the Lannett website and is arranging for return of all recalled products. Wholesalers and distributors (direct customers of Lannett) that have Levetiracetam which is being recalled should contact Inmar for instructions with regard to returning any remaining stock. Consumers that have Levetiracetam which is being recalled should contact their pharmacy to return product.
Consumers with questions regarding this recall can contact Inmar by phone at (866) 255-4983, Monday-Friday, 9:00 a.m. - 5:00 p.m. (EST). Consumers with medical questions can contact the Lannett Medical Information Department at (844) 834-0530, Monday-Friday, 9:00a.m. – 5:00 p.m. (EST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.
The recall, which began in October 2018, was originally initiated due to a product complaint received for mislabeling. The pre-printed text content on the infusion bag (primary container) for the lot indicates product information as Levetiracetam in 0.75% Sodium Chloride Injection (1000mg/100ml). The label on the external foil pouch has the product information as Levetiracetam in 0.54% Sodium Chloride Injection (1500mg/100ml). To date, there have been no reports of adverse events related to this recall.
Patients who may have been administered the mislabeled product could experience adverse reactions such as somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma related to over dosage.
Levetiracetam Injection is an antiepileptic drug indicated for adjunct therapy in adults (more than 16 years of age) with the following seizure types when oral administration is temporarily not feasible: Partial onset seizures, Myoclonic seizures inpatients with juvenile myoclonic epilepsy, Primary generalized tonic-clonic seizures.
The batch was distributed in U.S.A. between August 14, 2018 and September 5, 2018.
The recalled batch is as follows:
|Levetiracetam in 0.54% Sodium chloride Injection, 1500mg/100mL||Gland Pharmaceuticals||43598-637-52||ABD807||05/2020|
Dr Reddy’s Laboratories, Inc has notified the distributors to arrange for return of any recalled product. Wholesalers, distributors, hospitals and pharmacies with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately for return/replacement/etc. of all recalled products. Wholesalers, distributors and pharmacies that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them. For instructions on returning product or additional assistance, call Inmar at 1-800-967-5952 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
If patients have questions regarding this recall or to report an adverse event, please contact the Company’s Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 10 p.m. ET, Monday through Friday. Patients should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being executed with the knowledge of the U.S. Food and Drug Administration.
Important Safety Information: Levetiracetam in Sodium Chloride Injection
What important information should I know about Levetiracetam in Sodium Chloride Injection?
- Levetiracetam is an antiepileptic drug indicated for adult patients 16 years of age and older when oral administration is temporarily not feasible.
- Treatment with Levetiracetam may cause changes in behavior such as aggression, agitation, anger, anxiety, apathy, depression, hostility, irritability, and psychotic symptoms.
- Levetiracetam may cause drowsiness, sleepiness, and fatigue.
- Levetiracetam may cause serious dermatological reactions. Levetiracetam should be discontinued at the first sign of rash.
- Levetiracetam should be gradually withdrawn to minimize potential of increased seizure frequency.
- Levetiracetam blood levels may decrease during pregnancy. It is recommended that patients be monitored carefully during pregnancy.
Who should not use Levetiracetam in Sodium Chloride Injection?
- Patients with a known hypersensitivity to levetiracetam should not take this drug as angioedema and anaphylaxis have been reported.
What should I tell my healthcare provider before taking Levetiracetam in Sodium Chloride Injection?
Before taking Levetiracetam in Sodium Chloride Injection, tell your healthcare provider if you:
- Have or have had suicidal thoughts or behavior
- Have or have had kidney problems
- Become pregnant or intend to become pregnant
- Are nursing
Tell your healthcare provider about all medications and herbal products you take, including prescription and over-the-counter medications, vitamins and herbal supplements.
What are possible side effects of Levetiracetam in Sodium Chloride Injection?
These are not all the possible side effects of Levetiracetam. Please refer to the Package Insert for a complete list of possible side effects.
Call your healthcare provider right away if you have any of the following:
- Changes in mood or behavior
- Signs or symptoms of an allergic reaction or increased swelling
- Signs or symptoms of a rash
The most common side effects of Levetiracetam in Sodium Chloride Injection?
What should I avoid while taking Levetiracetam in Sodium Chloride Injection?
- Avoid driving or operating machinery until you know how levetiracetam affects you as levetiracetam may cause dizziness and sleepiness.
For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs. To report suspected side effects, call Dr. Reddy’s Laboratories Medical Information Call Center at 1-888-DRL-DRUG (1-888-375-3784) or via email to firstname.lastname@example.org or contact the USFDA at 1-800-FDA-1088 (1-800-332-1088) or online at www.accessdata.fda.gov/scripts/medwatch/index.cfm.
Indication and Usage
Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible. Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of:
- Partial onset seizures in adults with epilepsy,
- Myoclonic seizures in adults with juvenile myoclonic epilepsy,
- Primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy.
Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose 100 mL dual port bag with an aluminum overwrap.
Antiepileptic Drugs[UPDATE 05/05/2009] FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. Since issuing safety alerts on December 16, 2008 and January 31, 2008, FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.
[UPDATE 12/16/2008] The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.
[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.
Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
The drugs included in the analyses include (some of these drugs are also available in generic form):
Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)
Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.