Genetic test for breast cancer approved

The US Food and Drug Administration (FDA) has just announced approval of a genetic test that will help determine which breast cancer patients will be best served by taking the drug Herceptin (trastuzumab) for treatment.  The new test, SPOT-Light HER2 CISH, measures the number of the HER2 gene in cancerous breast tissue. Read more

FDA Approves Intel’s In-Home Health Management Device

The US Food and Drug Administration (FDA) has just announced approval of a healthcare management tool developed by the innovative, high-tech company, Intel.  The device, the Intel Health Guide, allows patients to take a more active role in their health care when chronic conditions such as diabetes or chronic heart failure are present while remaining in closer contact with their caregivers. Read more

Double the Risk of Suicide Not Enough to Warrant Black Box Warning

In January, the US Food and Drug Administration (FDA) began the process of evaluating 199 studies of anti-seizure drugs commonly prescribed for epilepsy and other disorders due to reports of suicidal behaviors in patients taking them.  Their findings led them to request a black-box warning be placed on the prescription labels of all 11 drugs under evaluation because the risk of suicide doubled when taking these drugs.  The findings of the FDA evaluation were presented for discussion to a 20-member panel of advisers who voted unanimously on Thursday to deny the request for the black-box warning. Read more

FDA Seeks Strongest Label Warning for Epilepsy Drugs

The US Food and Drug Administration (FDA) has announced plans to ask that a black-box warning be required of epilepsy drug labels due to an apparent increase in suicidal thoughts and behaviors associated with some of these drugs. A black-box warning on a drug’s label is the strongest warning against adverse side effects allowed of the pharmaceutical industry. Read more

Did Gardasil Cause Jenny’s Paralysis?

Jenny was a healthy, happy 13-year-old from Northern California until about 15 months ago when signs of muscle deterioration began appearing.  At that time, she’d also completed the third and final dose of Gardasil, the vaccine given to guard against contracting the human papillomavirus (HPV), linked to a large number of cervical cancer cases.  Cervical cancer is the second most deadly form of cancer in women.  Today, her mother describes Jenny as almost completely paralyzed. Read more

Don’t Get Burned by Your Sunscreen

The plight of 6-year-old Emily Crawley and her little sister, Claire, 3, has brought the safety of sunscreens into question.  The girls’ mother, Michelle, a self-proclaimed sunscreen “freak,” slathered her daughters with sunscreen as usual when the Ohio family recently vacationed in Key Largo, Florida.  Unfortunately, the girls soon became “fried beyond belief.” Read more

FDA Rejects Gardasil for Older Women

The pharmaceutical company, Merck & Co. Inc., won approval in 2006 from the US Food and Drug Administration (FDA) to market Gardasil, the first vaccine ever approved for the prevention of infection from human papillomavirus (HPV), which often causes cervical cancer.  Gardasil is approved for use only in young females, those between the ages of 9 and 26. Read more

FDA Cracking Down on Fake Cancer Cures

Taking coral calcium, bloodroot, or shark cartilage to cure cancer?  What about Cat’s Claw, the herbal tea Essiac, cesium, or ellagic acid?  Or any varieties of mushrooms touted as cures for cancer?  If so, the US Food and Drug Administration (FDA) wants you to know these products have not been proven to live up to their marketing claims and they may even be bad for your cancer and your overall health. Read more

More Antipsychotic Drugs Get Stronger Warning Labels

The US Food and Drug Administration (FDA) announced today that some “conventional” antipsychotic prescription drugs must now carry a black box warning label just like the one that has come on newer antipsychotic drug labels since an FDA order in 2005. The black box message is that the drugs increase the risk of death for elderly patients suffering from dementia. Read more

Mercury Fillings Risky to Pregnant Women, Children: FDA Revises Ruling

The US Food and Drug Administration (FDA) has just posted on its website a revised ruling on the safety of mercury dental fillings when used in pregnant women and in small children.  These silver-colored amalgams are made from a mixture of metals, almost half of which is mercury, that releases mercury vapor during the process of chewing and whenever they are placed or removed by a dentist. Read more

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