According to a whistle-blower, a U.S. unit of Takeda Pharmaceutical Co. failed to accurately report hundreds of congestive heart failure cases associated with Actos, its diabetes drug.
Takeda did not properly classify “non-hospitalized or non-fatal” congestive heart failure cases as serious over a two-plus year span, according to the complaint. Drug manufacturers are required to update the U.S. FDA’s Adverse Event Reporting System.
“These events were not properly identified or reported in the FDA’s safety database,” former Takeda medical review Helen Ge claimed in the complaint, filed in June 2010 and recently unsealed. “Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’s safety profile and to increase sales.”
Seven lots of Glenmark Generics generic birth control pills Norgestimate and Ethinyl Estradiol have been recalled due some blister packs putting the tablets in the wrong order, causing the pills to be ineffective.
The recall includes oral contraceptives distributed nationwide between September 21 and December 30, 2011. The mistake was discovered when a consumer of the pills told Glenmark the tablets in her package were in reverse order.
The blister packaging on the recalled pills was rotated 180 degrees, causing the pills to be in the reverse order. The expiration date of the recalled pills is only visible on the outer pouch. Any blister pack with no lot number or expiration date is subject to recall.
Consumers using the recalled pills should immediately begin using a non-hormonal form of contraception and notify their physician immediately. The recalled pills should be returned to the pharmacy that administered them.
Johnson & Johnson is taking all infant Tylenol off the shelves in the United States due to problems some parents have experienced with the new bottle design. The new design, introduced about three months ago, was intended to be seen as an improvement in safety by making the measuring process easier.
The bottle redesign received an unexpected reaction when 17 caregivers complained that the cover on top of the bottle was not functional. Consumers have claimed that the cover, which is intended to limit the amount of medicine that is drawn into a plastic syringe, pushes the protective cover into the bottle when inserted into the plastic syringe.
The first court hearing regarding an Actos lawsuit has been scheduled by a federal judge in Louisiana. The claim is that Actos, a diabetes drug, is related to an increased risk of bladder cancer.
U.S. District Judge Rebecca Doherty was assigned to preside over the many Actos lawsuits against Takeda Pharmaceuticals America, Inc., the makers of Actos.
Takeda’s parent company pulled the drug from shelves in Germany and France in 2011, but continued to sell the drug in the United States, despite the FDA warning announcing the possible risk of bladder cancer developing in Actos users.
The manufacturer of the SSRI drug Zoloft has filed a motion to merge all federal Zoloft lawsuits related to Zoloft birth defects. Pfizer Pharmaceuticals is requesting that the Zoloft lawsuits be combined and presented before one judge.
A study has revealed a link between nursing home residents with dementia who have used an SSRI drug and an increased risk of a fall resulting in injury when compared to residents who have not used an SSRI. According to the authors of the study, SSRI drugs, even when taken in low doses, have shown an association with an increased risk of a fall resulting in injury in nursing home residents with dementia.
When an SSRI drug is taken in combination with a hypnotic or sedative, the risk increases even more, according to the study.
This study, published in the British Journal of Clinical Pharmacology, analyzed “daily drug use and daily falls over a 2-year period” in close to 250 nursing home residents diagnosed with dementia. The average age of the residents in the study was 82 years old.
Three couples have filed lawsuits that claim Takeda Pharmaceutical Company Limited, the manufacturer of Actos, hid the fact that the drug has been associated with a risk of cancer.
The three men involved in the suit claim to have taken Actos daily as a part of their type-2 diabetes treatment given to them by their doctor. It took several years for the men learned of the association between the blood-sugar lowering medication and increased risk of developing bladder cancer.
According to the complaint, all three men involved in the lawsuit have been diagnosed with bladder cancer since taking Actos.