FDA Consumer Update: Statin Risks

Millions of Americans take statins for heart disease prevention. The FDA has released new important safety information regarding these cholesterol-lowering medications.

According to the FDA, some brain-related impairments, such as memory loss, forgetfullness and confusion has been reported by some statin users. The FDA also reports that statin users face a potential increased risk of higher blood sugar levels and the development of Type 2 diabetes.

The FDA will be updating the package insert of some statin products to communicate these new concerns.

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Bottle Design Problems Cause Infant Tylenol Recall

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.

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First Hearing for Actos Lawsuit

Actos Lawsuit

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.

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FDA Consumer Update: Toothbrush Can Cause Chipped Teeth and Choking

Users of electronic toothbrushes beware. The FDA released a consumer update warning users of the Arm & Hammer Spin Brush, also known as the Crest Spinbrush, of unexpected dangers. The FDA alerts consumers that parts of the device may pop off and could chip your tooth, fly into your eye, or get stuck in your throat.
According to a consumer safety officer at the FDA, “It’s important that consumers know how to avoid the risks associated with using the Spinbrush. We’ve had reports in which parts of the toothbrush broke off during use and were released into the mouth with great speed, causing broken teeth and presenting a choking hazard.”
Toothbrushes, both manual and electric, are regulated by the Food and Drug Administration as medical devices used to help prevent tooth decay. The FDA states that safety precautions should be taken with electric toothbrushes.

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Zoloft Lawsuit Consolidation

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.

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SSRI Use Raises Risk of Falls Resulting in Injury

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.
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FDA Vaginal Mesh Update

According to the FDA, manufacturers have been asked to perform more studies in order to acquire additional information on the safety of transvaginal mesh, a surgical mesh device used in pelvic organ prolapse (POP) treatment.
In July of 2011, the FDA released a safety warning regarding the serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. The warning explained that mesh used in transvaginal POP repair is associated with risks that are not apparent in traditional, non-mesh surgery for POP repair. The FDA also noted that the use of transvaginal mesh may not work better than a traditional POP repair without mesh.
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Takeda named in suits over use of Actos

Actos lawyerThree 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.

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FDA Warns About Cipro, Other Antibiotics

Drug safety officials on July 8, 2008, imposed the government’s most urgent warning on Cipro and similar antibiotics. Officials cited evidence that they may lead to tendon ruptures, a serious injury which can leave patients incapacitated and needing extensive surgery.

The FDA ordered makers of flouroquinolone drugs — a potent class of antibacterials — to add a very visible “black box” warning to their products and write new literature warning patients.

The two leading drugs covered by the warning are Bayer’s Cipro and Ortho-McNeil’s Levaquin. Cipro became a household name during the hysteria after the anthrax attacks of 2001. Cipro is thought to be effective against that bacteria, and it’s among the medications stockpiled by the government. In everyday medicine, Cipro is often used to treat urinary tract infections. Levaquin is generally used to treat respiratory infections.

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