On 22 Jul 2022, the European Medicines Agency (EMA) has recommended that Rubraca (rucaparib camsylate) should no longer be used as third-line treatment for cancer, as a study that was designed to confirm the benefit of Rubraca failed to do so, and showed that treatment may be associated with a …
On 21 July 2022, Medicines and Health care products Regulatory Agency (MHRA) released a drug safety update stating, initiation of new safety review into topiramate because of increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy. The new safety review was triggered by a large observational study …
National Pharmaceutical Regulatory Agency (NPRA) of Malaysia release a notification on Risk of Pheochromocytoma associated with Systemic Corticosteroids. Corticosteroids are anti-inflammatory drugs used for asthma and arthritis. Betamethasone, dexamethasone, prednisolone, methylprednisolone, triamcinolone, are types of systemic corticosteroids that are registered and currently in use in Malaysia. Pheochromocytoma crisis is actually …
The U.S. Food and Drug Administration (FDA) is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. Despite the change, most patients should stop statins once they learn they are pregnant. As per FDA, Patients should not breastfeed when taking a statin because the medicine …
The Therapeutic Goods Administration (TGA), in conjunction with Sandoz Pty Ltd and Novartis Australia, has investigated reports of counterfeit Somatropin HGH vials in community circulation. From this investigation the TGA has established that Novartis-Bio Somatropin HGH (191 amino acid sequence rDNA origin for injection) 3.7mg per Vial (10x10IU Vials of …
Xeljanz with active ingredient of Tofacitinib is used to treat certain types of arthritis (such as psoriatic arthritis, rheumatoid arthritis, polyarticular course juvenile idiopathic arthritis-pcJIA). It helps to decrease pain/tenderness/swelling in the joints. Tofacitinib is also used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach …
EMA had released its first safety update on a COVID-19 vaccine — Comirnaty. It concludes that safety data collected on Comirnaty use in vaccination campaigns is consistent with the known safety profile of the vaccine, and no new side effects were identified. Summary points: The latest safety data for this vaccine are …
Elmiron (pentosan polysulfate sodium / “PPS”) was approved by the FDA in 1996 for the treatment of interstitial cystitis (“IC”), also known as “bladder pain syndrome” or “painful bladder syndrome” and it is the only drug approved to treat pain associated with IC. In recent years, there have been reports …
Metamizole (also known as dipyrone) is a potent analgesic, antipyretic and nonsteroidal anti‐inflammatory drug (NSAID) used in the treatment of pain, fever, and spasms. This medicine was introduced into the market nearly 100 years ago. Due to serious adverse drug reactions like agranulocytosis, this medicine was withdrawn in many countries. …
Medicines and Healthcare products Regulatory Agency (MHRA) issued warning to women using modafinil during pregnancy as increased risk of birth defects is identified with the drug. Modafinil is a prescription-only medicine that is licensed only for the treatment of narcolepsy, a chronic disorder associated with sudden sleep that can cause …
