Pistachios Recall Salmonella Warning

A California pistachio processor issued a nationwide voluntary recall on Tuesday of pistachios due to potential salmonella contamination.

The U.S. Food and Drug Administration and the California Dept. of Public Health are investigating the matter. Thus far, several illnesses have been reported by consumers that may be associated with the pistachios, the FDA said.

The recalled nuts were shipped on or after Sept. 1, 2008 by Setton Pistachio of Terra Bella Inc.

Propafenone HCL Tablets Recall

Propafenone HCL Tablets 225 mg Recall

Recalled lot number: 112680A, expiration date July 31, 2010
Product Name: Propafenone HCL tablets
Shipped: Between October 15, 2008 and November 26, 2008.

The lot is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. The recalled tablets were manufactured by Watson Laboratories, Inc.

Because it has a narrow therapeutic index, some patients who are particularly sensitive to small variations in dose may experience potentially , including arrhythmias (irregular heartbeat) or low blood pressure.

Propafenone is a drug product used to treat cardiac arrhythmias (irregular heartbeats). It has a narrow therapeutic index, so some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. Consequently, as a precautionary measure, Watson is recalling this one lot to the consumer level to minimize any potential risk to patients.

Anyone who has 225 mg Propafenone HCL tablets should check the bottle for the lot number and expiration date to see if they have tablets being recalled. Anyone with 225 mg Propafenone HCL tablets being recalled should call (888) 352-9616, Monday through Friday, 8:00 a.m.-5:00 p.m. EDT, for instructions on how to return affected product.

Patients using 225 mg Propafenone HCL tablets who have medical questions should contact their health-care provider.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch

FDA Warns of Health Risk for Sharing Insulin Pens

According to the FDA, sharing insulin pens can put patients at risk of transmitting hepatitis viruses, HIV, and other blood-borne pathogens.

Insulin pens are not designed, and are not safe, for one pen to be used for more than one patient, even if needles are changed between patients because any blood contamination of the pen reservoir could result in transmission of already existing blood-borne pathogens from the previous user.

The FDA is working with the Centers for Disease Control and Prevention, professional societies and health care organizations to reinforce patient and health care provider education about proper and safe use of insulin pens.

Baxter Infusion Pump Recall

A Class 1 Recall of  Baxter infusion pumps by the FDA.

Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter
The Model numbers are:

• Mono 2M8151 and 2M8153

• CX 2M8161 and 2M8163

• CXE 2M9161 and 2M9163

The defective Pumps were manufactured and distributed from February, 1997 through December, 2008.

The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter to all of its customers, which included advice and instructions to institutions using the infusion pumps.

Chinese Drywall Lawsuit by Florida Homeowners

Florida Home owners have filed another Chinese Drywall Lawsuit.  This is the latest of four lawsuits filed so far and allege that tens of thousands of florida homes could be built with the defective Drywall from China.

Several homeowners have complained of  “rotten egg” smells coming from the drywall. Drywall is usually manufactured in the United States but due to recent shortages, many contractors were forced to use the Chinese made Drywall.

The company behind the supply of the defective products  is Knauf Plasterboard Tianjin Co. Ltd. of China, a subsidiary of German-based manufacturer Knauf Group.

The health department  said that most of the homes being investigated were built after 2004, but one home that is the subject of complaints was built in 2001.

The U.S. Consumer Product Safety Commission and Florida Department of Health have announced their own investigations to determine whether the Chinese drywall poses a threat to public safety or health.

The U.S. Consumer Product Safety Commission said last week it was investigating complaints that Chinese-made drywall was emitting odors and causing appliance problems in homes.

Several people have come forward and many more are expected to as Florida homeowners find out that issues are related to the Chinese Drywall.

Reglan Tardive Dyskinesia Warning by FDA

FDA MedWatch – 2009 Safety Alerts for Human Medical Products
Metoclopramide-Containing Drugs

The FDA announced today that the side effects from metoclopramide, ( a main ingrediant in many Reglan products) and a Gastrointestinal Medication, should be warned of a very serious disorder called tardive dyskinesia.

The FDA alerted healthcare officials that makers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use.

Metoclopramide usage of a long period of time has been linked to tardive dyskinesia, which can include involuntary and repetitive movements of the body. Even if you have not taken the drug for a while it sometimes can still occour.

The symptoms are often if not almost never reversible and there is no known treatment.

Metoclopramide is available in a variety of formulations including tablets, syrups and injections.

The Makers will be required to use a risk evaluation and mitigation strategy [REMS] to make sure that patients are provided with a medication guide that discusses this risk.

Makers include Baxter International Inc (BAX.N) and several generic drug companies.

More than 2 million Americans use the medicines to treat gastroesophageal reflux disease and other stomach ailments, the FDA said.

Products that commonly contain metoclopramide:

1. Reglan Tablets
2. Reglan Oral Disintegrating Tablets
3. Metoclopramide Oral Solution
4. and Reglan Injection

According to Watergate Summer Whistle Blower,Mom and Nurse; “Many people take this med for Reflux and GI Ulcer symptoms and take for long periods of time.”

What is tardive dyskinesia?

Tardive tourettism is a tic disorder that can closely mimic Tourette Syndrome, sometimes to the point where the two can only be distinguished by the details of their onsets.

Tardive dyskinesia is a variety of dyskinesia (involuntary, repetitive movements) manifesting as a side effect of long-term or high-dose use of dopamine antagonists, usually antipsychotics. Other dopamine antagonists that can cause tardive dyskinesia are drugs for gastrointestinal disorders (e.g. metoclopramide) and neurological disorders.

Video: The Treatment of Tardive Dyskinesia with … MORE Drugs!

Other Drugs that can cause tardive dyskinesia are mainly antipsychotic medications and include:

• Thorazine (Chlorpromazine)
• Clozaril (Clozapine) (may also treat the condition)
• Haldol (Haloperidol)
• Seroquel (Quetiapine)
• Loxitane / Loxapac (Loxapine)
• Mellaril (Thioridazine)
• Navane (Thiothixine)
• Prolixin / Modecate (Fluphenazine)
• Piportil (Pipotiazine)
• Trilafon (Perphenazine)
• Orap (Pimozide)
• Stelazine (Trifluoperazine)
• Risperdal (Risperidone)
• Serentil (Mesoridazine)
• Zyprexa (Olanzapine)

Some of the non-neuroleptic drugs that may also cause tardive dyskinesia are:

• Prozac (Fluoxetine)
• Zoloft (Sertraline)
• Nardil (Phenelzine)
• Elavil (Amitriptyline)
• Asendin (Amoxapine)
• Sinequan (Doxepine)
• Tofranil (Imipramine)
• Lithium
• Cocaine and other street drugs

Symptoms of Tardive Dyskinesia
Tardive dyskinesia is characterized by repetitive, involuntary, purposeless movements such as:

• Fine, worm-like movements of the tongue
• Lip smacking
• Chewing or sucking movements
• Grimacing (making faces)
• Puckering or pursing the lips
• Tongue protrusion
• Rapid eye blinking

Thanks to about.com for this list

A Very Detailed Article about Tardive Dyskinesia on Medscape

Defective Drug News

Othe Resource: Soulful Sepulcher

Technorati Related: health, tardive, dyskinesia, reglan, side, effects, disorders

Stomach Medicine Side Effects Require Box Warning by FDA

Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible and there is no known treatment.

Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection.

More about : Reglan and Tardive Dyskinesia

BPA baby bottle Ban – NY Law Makers Vote

The ban on Bisphenol-A (BPA) was approved unanimously by the Suffolk County Legislature on Tuesday. It will take effect if County Executive Steve Levy signs it, but he has not indicated whether he will do so.

The FDA had said last fall that BPA was safe, but after an independent report found deep flaws in its study the agency announced in December that it was planning more research.

Bill would Strengthen the FDA with more Authority

The legislation would expand FDA access to food company records and tests, give it authority to order mandatory food recalls, and increase funding.

Lawmakers and critics say this bill is a step in the right direction, but a step that should have been taken years ago.

Industry is open to change, said Scott Faber, a top lobbyist for the Grocery Manufacturers Association, which represents large food and beverage companies.

“The food industry recognizes that we need to give FDA new powers and new resources to address new challenges,” Faber said.

Businesses are concerned about reorganizing the entire system. The priority should be strengthening the current agencies before rearranging them, he said.

The GAO, the investigative arm of Congress, recommended two years ago that Congress re-examine the system. It said 76 million people are sickened by food-borne illness each year, and 5,000 die.

But few changes have been made. And despite the salmonella outbreak, even the lawmakers urging changes say a streamlined new agency is unlikely any time soon.

 

In related News, a study suggests that the FDA should have more oversight on supliments.  More than half of all American adults, or at least 114 million people, use dietary supplements like vitamin pills, diet pills, herbs and energy drinks. But the Food and Drug Administration does not have enough authority to ensure that the products are safe, and it should seek more oversight power, according to a government audit released Tuesday.

In January, the Food and Drug Administration issued a warning on 69 weight-loss products. The agency, however, cannot require manufacturers to remove supplements from shelves.

The new report from the federal Government Accountability Office acknowledged that the F.D.A. had taken some steps in the last few years to supervise the supplement industry more closely — but the report said those steps did not go far enough.

In the first 10 months of last year, for example, the audit said the F.D.A. received 948 reports of health problems associated with dietary supplements, but not necessarily directly caused by them. Those included 9 deaths, 64 life-threatening illnesses and 234 hospitalizations.

Congress requested the evaluation of how the FDA regulates these popular products. The Nutrition Business Journal reports that 79% of adult Americans take dietary supplements.

The GAO listed a number of areas in which the FDA has little oversight. For example, supplement companies don’t have to tell the FDA what products they sell or ingredients they use.

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No Limit on Lawsuits against Drug Makers upheld by Supreme Court

In a win for consumers, the United States Supreme Court has upheld a law that would have limited the amount of money in lawsuits against drug makers.

The Supreme Court has upheld a $6.7 million jury award to a musician who lost her arm because of a botched injection of an anti-nausea medication. The court brushed away a plea that it limit lawsuits against drug makers.

In a 6-3 decision Wednesday, the court rejected Wyeth Pharmaceuticals’ claim that federal approval of its Phenergan anti-nausea drug should have shielded the company from lawsuits like the one filed by Diana Levine of Vermont.

The decision is the second this term that rejected business groups’ arguments that federal regulation effectively pre-empts consumer complaints under state law.