Monthly Archives: May 2009

Bisphenol-A Products Banned in Chicago

The Chicago City Council voted unanimously yesterday to ban all products manufactured with the dangerous chemical bisphenol-A. Council members decided to tackle the issue themselves after complaining that the FDA was too slow in moving against the dangerous chemical.
Bisphenol-A, which is widely found in plastic containers such as baby bottles and cups, has been linked to cancer, heart disease and diabetes. The chemical is used to harden plastics but has been found to leak into the inside of the container posing a risk to those who use the plastic for human consumption.
According to the NY Times, Chicago is the first municipality to take such a step but it’s not the first government to wade into the controversy. Minnesota Governor Tim Pawlenty signed a measure last week prohibiting plastics that contain bisphenol-A.
While local governments act to protect consumers, the FDA continues to study the issue. If the FDA continues to drag its feet, more governmental bodies are sure to follow suit. It’s time the FDA did its job and protect the American public from a hazardous chemical. It shouldn’t take local governmental action to deal with the problem if the federal agency tasked with it does its job.

Heparin Linked to Two Recent Deaths

The FDA is investigating the connection between two recent deaths at a Delaware hospital and tainted heparin. Just last year, 80 people tied as a result of receiving contaminated heparin.
Heparin, sold by Baxter International, is widely used in the United States and around the world as a blood thinner. Last year, heparin was the subject of a massive recall after it had been determined that it had been tainted with oversulfated chondroitin sulfate by manufacturers in China.
This time, the FDA believes the heparin was manufactured in China. Additionally, these two deaths involved patients with intracranial bleeding, not the allergic reactions linked to the Chinese contaminated heparin.
The FDA is testing the heparin bags but they don’t believe the recent deaths are related to what happened a year ago. The FDA is trying to determine the exact nature of the heparin-related deaths in Delaware.

Hydroxycut Isn’t the Only Dangerous Diet Drug

According to Public Citizen, a consumer watchdog group, there have been 72 diet drugs or weight loss supplements that have been spiked with the active ingredients from prescription drugs. And this is only in the past six months! The FDA continues its investigation of these diet drug companies and will issue stiffer penalties if the companies fail to respond or pull their dangerous products from the market.
According to the FDA, they’ve found at least 9 prescription drugs added to diet drugs including:
Sibutramine (MERIDIA)
Fenproporex
Fluoxetine (PROZAC, SERAFEM)
Bumetanide (BUMEX)
Furosemide (LASIX)
Rimonabant (ZIMULTI)
Cetilistat
Phenytoin (DILANTIN)
Phenolphthalein
Obviously, this is a huge public health hazard. Some of these drugs haven’t even been approved for use in the United States. Yet, these diet drug companies, fueled by the diet craze and huge profits, are willing to take the risk of an investigation by the FDA.

Medical Device Company Settles with NJ Attorney General

Medical device manufacturer, Synthes, has settled a conflict of interest inquiry with the New Jersey Attorney General. The inquiry was pursued to protect consumers from fraud involving doctors who are paid consultants to the medical device company while also paid to test and recommend these same medical devices for consumer use.
As part of the settlement agreement, Synthes, manufacturer of Pro Disk artificial spinal disk, may pay the AG’s office $236,000 for its investigation as welll as full disclosure of doctors who are on their payroll. The agreement calls for full disclosure of medical professionals who are testing medical devices for approval while at the same time being remunerated by the same company as consultants.
In her letter to the FDA and Congress, New Jersey Attorney General Ann Milgram was highly critical of the FDA for doing nothing to police and monitor these conflicts. She cited instances where doctors signed and dated disclosure forms but left the rest of the forms blank.
The FDA has to make this a priority. Too often doctors and other medical professionals are caught in serious financial conflicts with the medical device companies and pharmaceutical companies. When they are paid company consultants, it’s hard to imagine that their testing and recommendations will be negative if they stand to lose money if the device or drug is not approved. This is clearly not good for consumers who must rely on FDA approval as assurance that the particular drug or medical device is safe and effective.

Vaginal Sling Lawsuit

According to an article in the NY Times, Amber Suriani had just turned 40 when she noticed she was experiencing urinary discharge. As an avid athlete, Suriani didn’t want these embarassing occurrences affecting her active lifestyle so she sought medical advice. Her doctor diagnosed the problem as stress urinary incontinence and recommended surgery to correct the problem. After being assured that it was a fairly minor procedure that would correct the problem, Suriani agreed to have a vaginal sling inserted under her urethra. The surgery was performed with no complications and Suriani returned to a normal lifestyle until a few months later she noticed bloody vaginal discharge. She was understandably concerned that she may have cancer so she went back to her doctor. Surgery was performed to remove part of the offending sling that, according to her doctor, was causing the problem. Unfortunately, Suriani’s difficulties only grew worse. The sling continued to cause problems and growing pain. Since then, she’s endured four more surgeries to remove the offending portions of the sling.
The vaginal sling, manufactured by ObTape (acquired by Johnson & Johnson), was designed to treat female urinary incontinence. It didn’t fix the problem in Suriani’s case. It exacerbated the problem to the point she decided to take legal action against the company. The medical device company stopped selling the device in 2006 but insists that it was a good device that helped thousands of women.
As the Times article points out, the problems encountered with this medical device bring more scrutiny upon the FDA’s guidelines and methods for allowing medical devices to be sold in this country. Unlike pharmaceutical drugs, the FDA “clears” medical devices rather than approves them. The criteria for clearance is minimal. The new device need only be similar in design and use as previously cleared medical devices. In other words, the medical device is never tested or approved as safe and effective, a standard by which drugs are approved.
This is a clear gap in the FDA’s regulatory process. Medical devices should be approved only after they are demonstrated to be safe, reliable, and effective. Hopefully, passage of the 2009 Medical Device Safety Act will spur agency action to toughen standards for medical devices.

Sex Abuse Child Victim’s Act Goes to Special Committee Today

I’ve just been informed by a reliable source that a special committee of the NY State Legislature will consider both the Markey bill and the Lopez bill. As I’ve written in previous posts, the Markey bill is pro-justice and pro-survivor. It allows survivors a one year window to pursue justice against sexual predators and the institutions that protected them. The Lopez bill is nothing more than a bill that protects predators, hurts victims, and insulates institutions from their bad behavior.
According to my source, the committee will hear from both Markey and Lopez and either recommend one bill move forward, seek compromise legislation, or kill the measures outright. If you were sexually abused in NY and seek justice, please urge your legislators in NY to do the right thing and vote for the Markey bill.

Hydroxycut One of Many Potentially Dangerous Supplements

Hydroxycut, voluntarily recalled from the marketplace on Friday, is just one of literally thousands of fat burning, weight loss, muscle producing diet supplements manufactured by an unregulated, multi-million dollar supplement industry. You only need visit a fitness store like GNC or a local gym to find a multitude of products that promise weight loss or muscle mass without supporting those claims through scientific fact or FDA oversight.
While the FDA has its hands full with the job it presently has, we need federal oversight of this industry before consumers are seriously and permanently injured.

FDA and Hydroxycut

While complaints about the dangers of the dietary supplement Hydroxycut have been around for years, the FDA never issued a consumer warning about the weight loss drug until yesterday. According to the FDA, the complaints were infrequent and were not definitively linked to liver damage or other health concern.
Unfortunately for consumers, diet supplements and weight loss pills and formulas are not regulated by the FDA. Unlike prescription drugs, these products don’t have to be evaluated or approved by the FDA prior to market launch. As a result, they are marketed as “all natural” and “healthy” even though there is no scientific evidence to support such claims. Additionally, people are often mislead to believe that a product marketed as “natural” is automatically safe. This is patently false. Many natural products are toxic and can cause serious harm to the human body and its internal organs.
In prior doses, Hydroxycut even contained the banned Ephedra. In fact, Ephedra was part of the chemical ingredients that comprised Hydroxycut until 2004 when it was removed.
The FDA is still evaluating what chemical, herb, or natural extract has caused the liver toxicity. In fact, it may be a combination of ingredients that have caused liver injury. Furthermore, the FDA does not know if its a problem with dosage, chemical ingredients, or the length of time that one is exposed to Hydroxycut. These answers should be forthcoming in the next weeks or months as the federal agency studies the weight loss formula. In the meantime, if you’ve used Hydroxycut stop using it immediately. If you show signs of liver disease such as jaundice, brownish urine, or light-colored stools, contact your healthcare professional.

Hydroxycut Lawsuit Weight Loss Drug Recall

A class action lawsuit will most likely be the result of today’s recall of the popular diet drug Hydroxycut. The fat burner has been highly and aggressively touted on television, radio, and the Internet for years. Many people who have tried to lose weight as well as health and fitness disciples have taken the drug in order to sculpt their bodies or lose weight.
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However, like Fen-phen and Ephedra, Hydroxycut has serious health consequences. Fen-phen caused cardiac problems including primary pulmonary hypertension. Hydroxycut has been linked to liver toxicity. Our firm has already been contacted by consumers who’ve been advised by their healthcare professionals that they have liver problems.
Diet drugs such as Hydroxycut are marketed as quick fixes and miracle drugs but they are not regulated or approved by the FDA. This lack of regulation has led to needless suffering for those who’ve taken these harmful drugs.
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FOR IMMEDIATE RELEASE
Recall attorney Saunders & Walker with FDA Warns Consumers to Stop Using Hydroxycut Products recall
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury and will likely result in lawsxuits
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.
The FDA and lawyers has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.
Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:
Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural
Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.
Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.