Product News and Recalls

Gene therapy promising for Alzheimer’s treatment

A recent study linking Alzheimer’s disease with the repression of gene activity in the brain is a promising development in potential treatment of the disease, according to a recent news release by the National Institutes of Health.

“These findings provide a glimpse of the brain shutting down the ability to form new memories gene by gene in Alzheimer’s disease, and offer hope that we may be able to counteract this process,” said Roderick Corriveau, Ph.D., a program director at NIH’s National ...

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Coalition demands more rigorous FDA screening

A coalition of patient, consumer, and public health groups urged the federal Food and Drug Administration to require more rigorous testing before a medical device used for addressing complications from aneurysm treatments can be sold.

“This decision by FDA sets a bad precedent for approving new devices,” said Lisa McGiffert, Director of Consumers Union’s Safe Patient Project. “Medical devices intended to save lives should require the FDA’s most rigorous safety testing. Bypassing such testing up front can put hundreds of thousands ...

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Members of Congress: Close FDA loophole

Four Democratic U.S. Representatives have introduced legislation designed to close a major loophole in the process by which the federal Food and Drug Administration approves medical devices. The legislation’s sponsors specifically cite vaginal mesh implants and metal-on-metal hip implants as dangerous and defective devices that have made it onto the market as a result of that loophole.

A news release from the bill’s main sponsor, ...

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FDA Panel: Yaz/Yasmin Birth Control Labeling Should Reflect Risks

A Food and Drug Administration panel of experts ruled that the labeling of the popular birth-control pills Yaz and Beyaz should be updated to reflect recent data showing the drug poses a higher risk of causing blood clots than older contraceptives.

Already, 10,458 lawsuits have been filed in federal court against pharmaceutical giant Bayer AG, maker of the contraceptives Yaz, Beyaz, and Yasmin. Plaintiffs claim they weren’t warned of the drug’s harmful side effects, according to the Southern District of ...

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Birth Control Pills Recalled Over Packaging Error

The federal Food and Drug Administration has announced that a batch of birth control pills has been recalled because of a packaging error that may leave women at risk of unintended pregnancy.

On Feb. 24, Glenmark Generics Inc. USA – the domestic distributor for Glenmark Generics Ltd. India – issued the recall of seven lots of norgestimate and ethinyl estradiol tablets.

According to a release by Glenmark, select blisters on the packaging were rotated 180 degrees within the card, reversing the weekly ...

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Unsafe Artificial Hip Marketed after FDA Rejection

The New York Times has reported that Johnson & Johnson marketed an artificial hip overseas after the federal Food and Drug Administration rejected its sale in the United States based on a review of company safety studies.

In addition, the company continued to sell a related model of artificial hip in the U.S. after the FDA rejection, which went on the market because the company used a regulatory loophole that enabled it to avoid a similar safety review

According to the Feb. ...

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