Boxed Warnings for Pregabalin and Gabapentin

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

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

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)

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

Moxifloxacin-Drug Safety Alert from US-FDA

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

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 Updates from Health Canada-June 2020

Drug Safety Alerts from Health Canada

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?

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

Drug Recall story of Ranitidine (An established drug since 3 decades)

A medicine having been considered as “Safe” since 1981 is recalled from the drug market. It’s not a surprise on recall of a drug from market which has an “assumed established safety profile”. Ranitidine, popularly known to public as Zantac, is a very common OTC (over the counter) drug and prescription stomach acid blocker widely

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