Dr Reddy's Recalls Epilepsy Drug Levetiracetam In US Over Mislabelling Concerns
The pharmaceutical company issued a risk statement that the patients who are administered the mislabelled product will likely experience serious side effects.
Dr Reddy's Laboratories Ltd. is recalling one batch of epilepsy drug Levetiracetam in 0.75% sodium chloride injection in the US over mislabelling concerns.
The product's Lot No: A1540076 of Levetiracetam in 0.75% sodium chloride injection, 1,000 mg/100 mL is being recalled because the infusion bag is incorrectly labelled as Levetiracetam in 0.82% sodium chloride injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, according to an exchange filing.
The affected batch was distributed nationwide in the US between Nov. 4 and Nov. 6 to wholesalers. "Because the infusion bag is labelled as 500 mg/100 mL but actually contains 1,000 mg/100 mL dose, the patient could receive double the dose of intravenous levetiracetam than intended, which could lead to adverse events," it said.
The pharmaceutical company issued a risk statement that the patients who are administered the mislabelled product will likely experience serious side effects, including hypersensitivity reactions, liver injury, hematological toxicity, somnolence, fatigue, dizziness, coordination difficulties, agitation, aggression, depressed level of consciousness, respiratory depression, and coma.
Patients receiving high doses of levetiracetam by rapid intravenous infusion for the treatment of status epilepticus would be most at risk for severe adverse events. Dr Reddy's has not received any reports of adverse events related to this recall, the filing said.
Levetiracetam in 0.75% sodium chloride injection 1,000 mg/100 mL, 10 mg/mL, and Levetiracetam in 0.82% sodium chloride injection 500 mg/100 mL, 5 mg/mL are indicated as adjunctive therapy for adults aged 16 years and older when oral administration is temporarily not feasible.
They are used in the treatment of the following seizure types — partial-onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy and primary generalised tonic-clonic seizures.
ALSO READ
Dr Reddy's Laboratories' Facility Gets FDA EIR With Voluntary-Action-Indicated Classification
Dr. Reddy's profit rose 2% in the third quarter of the current financial year, but missed analysts' estimates. The pharmaceutical company posted a bottom line of Rs 1,413.7 crore in the quarter ended December.
Shares of Dr Reddy's closed 0.11% lower at Rs 1,106.35 apiece on the National Stock Exchange, compared to a 0.33% decline in the benchmark NSE Nifty. The stock has fallen 12.41% in the last 12 months.
Fifteen out of 40 analysts tracking the company have a 'buy' rating on the stock, 11 recommend 'hold' and 14 suggest 'sell', according to Bloomberg data. The average of 12-month analysts' price targets implies a potential upside of 22%.
