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Fda Issues Safety Alert Over Sglt2inhibitors - Latest News


FDA issues safety alert on new class of Type 2 diabetes drug

An investigation will determine whether changes are needed in the prescribing information for the class of drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, the Food and Drug Administr... read more

FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes

... other antidiabetic drug classes over a period of more than 30 years. To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving ... read more

FDA issues safety alert for popular hair care product over hair loss complaints

The FDA began investigating the company after reports of hair loss, balding and rashes. Last month, the agency took the rare step of issuing a safety alert after learning the company had received 21,0... read more

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FDA: Cases of Rare Gangrene of Genital Area Tied to Diabetes Drug Class

The Food and Drug ... 2 (SGLT2) inhibitors, a class of drugs approved to treat type 2 diabetes. Necrotizing fasciitis of the perineum, also known as Fournier's gangrene, is a serious infection of the ... read more


Eli Lilly Gets Another Crack At FDA Approval For RA Drug

Eli Lilly gets allowance from the FDA to file for regulatory approval of its JAK inhibitor drug baricitinib for patients with rheumatoid arthritis. A setback by the FDA on safety issues caused baricit... read more

FDA Warning Wire: Plant Problems Behind Medtronic Recalls

Medtronic said in a statement on Tuesday that there have been no reports of patient death related to the issues the FDA pointed out ... isn't covered under its over-the-counter drug safety review proc... read more

It's Personal: EASD Focuses on Individualizing Diabetes Care

The SGLT2 inhibitors ... issues in type 1 diabetes as well as type 2 diabetes, Beguinot pointed out. Mid-day Thursday, metabolic results will be presented from Eisai's CAMELLIA-TIMI 61 trial of its ob... read more

Safety Risks Associated with Crushing or Altering Medication

"There are medications that should not be altered, because these changes may affect how the drug is absorbed and works in the body," said Matthew Grissinger, Medication Safety ... those over 65. Twent... read more

Watchdog audits fire warning shots at the FDA’s food safety program

ADVERTISEMENT In September 2017, the OIG issued a report that found that while the FDA ... safety violations to verify that the issues had been addressed. In nearly one in five instances, the agency n... read more

GlaxoSmithKline Catches Multiple Safety Nets From FDA For Blockbuster Drug Advair

GlaxoSmithKline received a second lifeline after the FDA rejected Mylan (MYL) generic version of Advair for a second time. Mylan had stated that the FDA could not approve the drug. The FDA stated that ... read more

U.S. regulators float ideas for boosting medical-device safety

The FDA has repeatedly been forced to issue safety alerts about unexpected problems with devices ... "We want to have better tools for detecting issues that occur post-approval," FDA Commissioner Scot... read more



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