One of the major problems in our country is the way drugs are distributed and information is provided to consumers. The drug companies have gone to national TV advertising. They spent a fortune letting the consumer know about the drug, but the drug companies are not required to give them all the warnings. Only the doctor knows the warnings. So you have a situation now, people are coming in to doctors and saying, “I want drug X,” which they saw on TV. They never would have asked for that drug had they not seen that TV commercial. So you have people with diabetes, who have a lot of illnesses to begin with, given a drug that increases the risk of some of those injuries. And eventually as a standard practice, instead of it being actually a recall, the drug company stopped selling the product. There’s no reason to approve of a drug if there’s a safer alternative.
Bisphenol A located in plastics with U.S. consumption by nearly 1 million in 2003 is now being banned by certain states that prefer to do so in 2010 instead of waiting for an FDA recall. Makers of the affected plastics with Bisphenol A include: Bayer Material Science, Dow Chemical Company, SABIC Innovative Plastics (GE Plastics), Hexion Specialty Chemicals and Sunoco Chemicals.
Polycarbonate plastic which is comprised with Bisphenol A has been popular for many types of products because it is clear and shatter-proof such as for food and beverage cans, baby bottles, sip cups, water bottles, sports equipment, medical devices, dental devices, dental fillings, dental sealants, eyeglass lenses, CDs, DVDs, and household electronics.
The CDC conducted studies from 1988 to 1994 that involved urine samples which resulted in 95% of adults and 93% of children having Bisphenol A in their urine. In 2009, another study identified that people drinking from polycarbonate bottles increased urinary Bisphenol A levels by two thirds to 2 micrograms/gram creatinine.
Bisphenol A Risks
The medical conditions that may result from excessive Bisphenol A include:
Genital tract abnormalities
Breast tissue abnormalities that predispose the breast to cancer and hormones
Reproductive dysfunction
Increase in prostate weight by up to 30%
Prostate cell disruption adding to risk of hormone increase and cancer
Decline in testosterone
Early puberty
Decrease maternal behavior
Adverse brain structure, behavior and neurological difficulties
Self Help to Protect from Harm
Avoid canned food and polycarbonate plastic containers
Contact policy makers in your state to ban products from sale such as Minnesota and Illinois have done.
Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010
FDA has authorized the emergency use of the investigational antiviral drug peramivir for certain adults and children hospitalized with confirmed or suspected 2009 H1N1 influenza. This includes patients who have an influenza A virus that is non-subtypeable and is suspected to be 2009 H1N1 based on cases in the community.
Peramivir, which is administered intravenously, is in the same drug class as Tamiflu and Relenza. Peramivir is authorized only under certain circumstances: when the patient is not responding to either oral or inhaled antiviral therapy, when other routes of drug administration are not expected to be dependable or feasible, or, in the case of adult patients, when the clinician judges that IV therapy is appropriate for other reasons.
Peramivir is not authorized to prevent influenza, to treat seasonal influenza, or to treat acute, uncomplicated 2009 H1N1 infection. Also, it should not be used in patients with severe allergies to Tamiflu (oseltamivir phosphate) or Relenza (zanamivir), or those who’ve shown resistance to Tamiflu.
Only CDC is authorized to distribute peramivir. Physicians who want to use it must apply through CDC’s Peramivir IV Electronic Request System. Once the decision is made to ship the drug, it may take up to 24 hours to reach the hospital.
Because peramivir is an unapproved drug with limited safety data, health care providers or their designees are required to report certain adverse events and all medication errors associated with peramivir to FDA’s MedWatch program. This must be done within 7 calendar days of the onset of the adverse event.
Video originally created by FDA -- posted by Lawsuit.com on January 19, 2010
FDA is alerting healthcare professionals and patients about deaths and serious complications from Negative Pressure Wound Therapy (NPWT). This therapy promotes wound healing by applying negative pressure to remove fluids and infectious materials from the wound area. NPWT is used in both acute and long-term care facilities and at home.
FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years. Although rare, complications can occur wherever these systems are used. Most of the deaths occurred at home or in a long-term care facility. Bleeding was the most serious complication, reported in all of the six deaths and in 17 of the injury reports. Other serious effects included worsening infection of the original open wound, retention of foam dressing pieces, or foam adhering to tissues or becoming imbedded in the wound.
FDA has several recommendations to help reduce the risk of serious complications with Negative Pressure Wound Therapy. Here are some of them:
• Select patients carefully. This therapy is contraindicated in patients with exposed vasculature, nerves, organs and anastomotic sites, and also for patients with untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, and necrotic tissue with eschar present. Also, carefully consider the use of this therapy in patients with certain risk factors, including those with a high risk for bleeding and hemorrhage, and those receiving anticoagulants or platelet aggregation inhibitors.
• Assure that the patient is monitored frequently by a trained practitioner in an appropriate care setting.
• Be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur.
• Finally, if the patient is a candidate for using a Negative Pressure Wound Therapy system at home, instruct the patient and any caregivers about how to use the system and ask them to demonstrate their understanding. Make sure they know the signs and symptoms of potential complications and what to do if they occur.
The settlement of lawsuits involving workers at popcorn plants who were exposed to lung disease causing diacetyl vapors has prompted the FDA to set stronger safety standards for popcorn manufacturing facilities. The FDA requires that the mixing bins be covered and operators must wear respiratory masks while working with diacetyl. The lawsuits consisted of popcorn workers who developed a rare lung disease called bronchiolitis obliterans which does not have a cure, other than lung transplantation.
The issues surrounding diacetyl may not end with popcorn manufacturing. Diacetyl may be found in Chardonnay wine, rum, brandy, butter, cheese, milk, bread, cake mixes, and coffee. Diacetyl is used to add flavor and texture to otherwise tasteless foods and drinks. A recent analysis of several types of Chardonnay wine uncovered varying concentration levels of Diacetyl, some of which was higher than the requirement necessary for flavoring.
It is suspected that diacetyl is not harmful to the general public. Yet, one member of the general public has suffered from diacetyl. This case involved a man who used a microwave to heat popcorn containing diacetyl on a daily basis for ten years. It is known that this type of lung disease is caused by diacetyl vapors produced by heating products that contain diacetyl.
To identify products that you may use which contain diacetyl, check product labels. Product labels list ingredients in order of concentration strength. Diacetyl definitely adds a smooth buttery taste to food and drink and is not considered harmful to the average person. Yet, it is important to know that diacetyl is may be found in products other than popcorn.
