Risk of severe hypocalcaemia with denosumab (Prolia): USFDA Drug safety communication

USFDA released a recent safety update for the denosumab Denosumab is a human monoclonal antibody which helps in preventing breaking down of bone cells (osteoclasts) from bone by inhibiting the receptors named – RANK (receptor activator of nuclear factor kappa beta) in the body. This medicine is intended for the treatment of following medical conditions: Osteoporosis

Potential increased risk of death and serious adverse effects with cancer medicine Copiktra (duvelisib): USFDA Drug safety communication

USFDA released a recent safety update for the duvelisib, which is used in the treatment of blood cancer – chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is a PI3 kinase inhibitor, which controls the multiplication and growth of cancer cells by blocking the signaling action of abnormal protein. After the product approval

Umbralisib and potential increased risk of death [under USFDA investigation]: Need for consistent evaluation of benefits & risks

USFDA released a drug safety communication for the updated significant safety information of the cancer medicine – umbralisib to disseminate awareness for optimal, safe & effective usage of this product in patients suffering from cancer of the lymph nodes and respective healthcare professionals involved in treating this patients. Ukoniq (umbralisib) is a cancer medicine used

Increased risk of heart rhythm problems with lamotrigine: Drug safety alert from USFDA

Lamotrigine is an anticonvulsant medicine been in the market for more than 25 years with the brand name Lamictal and also available in generics. It is used in the treatment of epileptic seizures and also as maintenance treatment for delaying the occurrence of mood episodes such as depression, mania, or hypomania in patients with the

Propylhexedrine: Potential risk of drug misuse, abuse and serious health consequences

United States Food & Drug administration (USFDA) released a drug safety communication to bring more awareness on potential drug misuse and abuse of propylhexedrine associated with serious complications like abnormal heart rhythm, high blood pressure, and paranoia. It is marketed under the brand name Benzedrex. Propylhexedrine is a nasal decongestant available in the retail pharmacy

Oligohydramnios associated with NSAID use in Pregnancy-Safety Communication from USFDA

Oligohydramnios associated with NSAID use in Pregnancy-Safety Communication from USFDA

United States Food and Drug Administration (US-FDA) has issued a safety communication on the potential risk of oligohydramnios in pregnant women when exposed to medicinal products that belongs to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) during pregnancy of 20 weeks gestational age. FDA issued this communication to alert health care professionals and consumers for

“Benadryl Challenge” in Social media: USFDA warns about serious safety concerns associated with diphenhydramine overdose

“Benadryl Challenge” in Social media: USFDA warns about serious safety concerns associated with diphenhydramine overdose

U.S. Food and Drug Administration (FDA) alerted health care professionals and general public through recent drug safety communication which concerns about serious risks (heart problems, seizures, coma, and sometimes fatal outcomes) due to allergy medicine-diphenhydramine administration higher than the recommended dosage and overdose occurrences due to ‘Benadryl Challenge’ circulating in Social media- TikTok. Diphenhydramine is

USFDA issues 'Boxed Warning' for Benzodiazepine class of medicines

Boxed Warning for Benzodiazepine class of medicines: US-FDA Drug Safety Communication

U.S. Food and Drug Administration (FDA) released a drug safety communication to update health care professionals and consumers on the significant safety information pertaining to the benzodiazepines class of medications which included “serious risks of drug abuse, drug addiction, physical dependence, and drug withdrawal reactions” which require a boxed warning to be included in all

Hydrochlorothiazide: Drug Safety Update (Label Changes) from USFDA

Hydrochlorothiazide: Drug Safety Update (Label Changes) from USFDA

A new safety labelling change for hydrochlorothiazide (HCTZ) drug was approved by United States Food and Drug Administration (US-FDA). Hydrochlorothiazide is loop diuretic (acts on kidneys by eliminating excess fluids) used in the treatment of high blood pressure and oedema associated with the congestive heart failure. A new safety information identified through routine pharmacovigilance (PV)

Class I Medical Device Recall: Medfusion 3500 and 4000 Syringe Pumps

Medfusion 3500 and 4000 Syringe Pumps: Class I Medical Device Recall by US-FDA

On 24-Aug-2020, US-FDA has released a recall alert for class I medical Device- Medfusion 3500 and 4000 Syringe Pumps due to risk of medication delivery error. Device Use: This is used in the delivery of following products into the patient’s body in a controlled manner. Blood Blood products Prescribed medications Other fluids Syringe pumps which

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