Drug safety alert Archives - Public Safety & Vigilance

Risk of Respiratory depression with Pregabalin: Drug Safety Alert from Europe Medicines Agency

Oct 20, 2021Public Safety & VigilanceDrug Safety Alert, Drug Safety Signal, EMA-European Medicines Agency, Global Safety Alerts, HPRA-Ireland, Medicinal Product Updates, PRAC, Product Label Updates, Safety Communications, Voluntary ADR reportingDrug safety alert, PRAC signal, Pregabalin, Respiratory Depression

Safety Alert: Serious risk of respiratory depression associated with the use of pregabalin even without concomitant use of opioid medications or other CNS depressants. Health Authority: Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) Pregabalin-containing medicinal products are marketed under various brand names for the treatment of following conditions: Generalized anxiety disorder…

Risk of acute pulmonary oedema with Nifedipine use during pregnancy

Aug 9, 2021Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, Medicinal Product Updates, TGA-Australia, Voluntary ADR reportingAcute pulmonary oedema, Drug safety alert, Nifedipine

Safety update: Risk of acute pulmonary oedema with Nifedipine when used for the treatment of preterm labor in pregnancy: Product label update from Therapeutic Goods & Administration (TGA) – Health authority of Australia. The ‘Fertility, pregnancy and lactation’ section of the nifedipine PI (section 4.6) has been updated to include the following information: ‘Acute pulmonary…

Boxed Warnings for Pregabalin and Gabapentin

Feb 20, 2021Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, Medicinal Product Updates, Safety Communications, TGA-Australia, USFDA-United States of America, Voluntary ADR reportingBoxed warning, Drug Abuse, Drug Dependence, Drug Misuse, Drug safety alert, Gabapentin, Pregabalin

Pregabalin is an anticonvulsant and anxiolytic medication used in the treatment of epileptic seizures, neuropathic pain, restless leg syndrome, fibromyalgia, and generalized anxiety disorder. Gabapentin is an anticonvulsant medication used in the treatment of partial seizures and neuropathic pain. Both Pregabalin and gabapentin which are referred as “gabapentinoids” acts on voltage dependent calcium channels in…

Potential risk of congenital malformations with the use of Modafinil during pregnancy

Nov 11, 2020Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, HPRA-Ireland, Medicinal Product Updates, Voluntary ADR reportingCongenital malformations, Drug safety alert, HPRA, Modafinil

Ireland Health authority, Health Products Regulatory Authority – HPRA has released a drug safety alert for modafinil association with congenital malformations (congenital heart defects, hypospadias and orofacial clefts) in foetus when exposed to a pregnant woman or to women of childbearing potential. Modafinil is a wakefulness promoting medicinal product used in the treatment of too…

Pirfenidone induced liver injury: Drug safety alert from Norwegian Medicines Agency

Nov 9, 2020Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, Norwegian Medicines Agency, Voluntary ADR reportingDrug safety alert, HCP letter, Norwegian Medicines Agency, Pirfenidone, Severe Liver injury

Pirfenidone used in the treatment of idiopathic pulmonary fibrosis (scarring of the lung tissue). It is an inhibitor of transforming growth factor (TGF)-beta (a factor which is involved in the proliferation and differentiation of cells) and it also inhibits the TNF-Alpha. Norway health authority (Norwegian Medicines Agency) identified a new safety alert for pirfenidone from…

Dimethyl fumarate induced Alopecia areata: Drug Safety Alert from Netherlands Pharmacovigilance Center (LAREB)

Oct 19, 2020Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, Medicinal Product Updates, Netherlands-LAREB, Pharmacovigilance, Signal DetectionAlopecia areata, Dimethyl fumarate, Drug safety alert, Lareb

A new drug safety signal “Dimethyl fumarate included Alopecia areata” identified by Netherlands Pharmacovigilance center, Lareb Dimethyl fumarate is an anti-inflammatory and immunomodulatory agent which is used in the treatment of relapsing multiple sclerosis and plaque psoriasis. Alopecia areata is an autoimmune disorder which involves loss of hair follicle with one or more circular bald…

Moxifloxacin-Drug Safety Alert from US-FDA

Aug 14, 2020Public Safety & VigilanceGlobal Safety Alerts, USFDA-United States of AmericaDrug safety alert, Moxifloxacin, TASS (Toxic Anterior Segment Syndrome)

Food & Drug Administration of United States has released a drug safety alert for Moxifloxacin to bring awareness to health care professionals with this safety information. Moxifloxacin is quinoline antibiotic which inhibits the growth of bacteria. It is used in the treatment of various bacterial infections. Moxifloxacin is available in two brand names in USA-Moxeza…

Drug Safety Alert From IPC-PvPI

Jun 2, 2020Public Safety & VigilanceCOVID-19 Medication, Drug Safety Alert, Drug Safety Signal, Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, PvPI-India, Safety Communications, Voluntary ADR reportingDrug safety alert, Hydroxychloroquine, Mouth Ulceration, PvPI

A new drug safety alert (Hydroxychloroquine-Moth Ulceration) released by the Pharmacovigilance Programme of India (PvPI) from Indian Pharmacopoeia commission (IPC) Mouth Ulceration associated with Hydroxychloroquine use Hydroxychloroquine is an antimalarial class of drug which is used in the treatment and prevention of acute attacks of malaria. It also used to treat discoid or systemic lupus…

Drug Safety Alerts from Health Canada

May 4, 2020Public Safety & VigilanceDrug Safety Signal, Drug Safety Updates, PharmacovigilanceDrug safety alert, Health Canada Safety Alerts, Hydroxyurea, Interstitial lung disease risk, Myocarditis, Nivolumab

Health Canada has released two new drug safety alerts to raise awareness to health care professionals and public about the two safety concerns which recently made safety labelling changes for the respective product monographs. –Health Product Info Watch – April 2020. Below are the two safety concerns discussed in brief. Interstitial lung disease risk associated…

Ranitidine drug status in India: Is it still used?

Apr 3, 2020Public Safety & VigilanceDrug Recall, PharmacovigilanceCarcinogenic medicine, CDSCO, Drug Ban, Drug safety alert, Drug withdrawal, Human carcinogen, Patient safety first, Ranitidine

Ranitidine has an Indian market size of Rs 750 crore which is also commonly used OTC and prescription medicine by wide range of patients (pediatrics, adults and the elderly patients) commonly used for intestinal and stomach ulcers, Gastroesophageal Reflux Disease (GERD), esophagitis, Zollinger-Ellison syndrome etc., It is a H-2 blocking agent, which decreases the amount…

Public Safety & Vigilance

A common platform for safety alerts, news and other important updates for Medicinal Products and Medical Devices from health regulatory authorities across the globe.