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

Class I Medical Device Recall: BodyGuard Infusion Pump System

Class I Medical Device Recall: BodyGuard Infusion Pump System

On 05-Aug-2020, US-FDA has released a recall alert for class I medical Device- BodyGuard Infusion Pump System due to the risk of over-fusion and under-infusion. Class I Medical Device Recall: As per the classification system by US-FDA, this device falls under the category of Class I medical device. This is the most serious type of

Naloxone use for opioid use disorder: US-FDA recommendation

USFDA Drug Safety Communication: Naloxone use for opioid use disorder

On 23-Jul-2020, United States Food and Drug Administration (USFDA) has released a recommendation for the use of Naloxone in the treatment of opioid use disorder and for patients who are at increased risk of opioid overdose. Opioids are a class of drugs which are used to reduce moderate to severe pain in patients who are

Recall of Class I Medical Device- GlideScope Core One TouchSmart Cable (“OneTouch cable”)

Recall of Class I Medical Device- GlideScope Core One TouchSmart Cable (“OneTouch cable”)

On 17-Jul-2020, US-FDA released a recall alert for class I medical Device- GlideScope Core One TouchSmart Cable (“OneTouch cable”) due to partial or complete loss of image during use. Device Use: The GlideScope Core Video Laryngoscopy System is intended to provide a clear view of the airway and vocal cords for medical procedures. The Core

error: Content is protected !!