Generic drug maker Ranbaxy Laboratories LTD has filed a corrective action plan with the U.S. Food & Drug Administration (FDA). The FDA barred some of Ranbaxy’s drugs from import to the U.S because of violations found during inspections of two plants in India. One of those plants was later cited for falsifying data on new and approved drug applications.

The FDA

said it received Ranbaxy’s corrective action plan on May 18. Neither the FDA nor Ranbaxy have disclosed what the plan entails. “The FDA is working very closely with the firm to ensure that all the Ranbaxy products currently in the U.S. market are safe and effective,” FDA spokesman Christopher Kelly said in an e-mail to Bloomberg.com yesterday. “The next steps will be dependent on the actions identified” in the plan, he said.

Based in India, Ranbaxy is one of the 10 largest generic-drug producers in the world and has been operating in the States since 1995. It has been involved in several scandals over the past year. US prosecutors filed a motion in federal court in Maryland last July alleging that Ranbaxy forged documents relating to an investigation into the quality of the company’s drugs sold in the this country. The investigation was also looking into allegations that Ranbaxy made weak or adulterated HIV drugs that were given to thousands of AIDS patients in Africa. Prosecutor also accused the company of concealing violations of good manufacturing practice regulations from FDA.

As we reported last September, the FDA had imposed an import ban on 30 different Ranbaxy drugs because of the agency’s concerns about the “seriousness and extent” of violations of manufacturing standards at its Paonta Sahib plant and a second Ranbaxy facility in India. At the time, officials said they were concerned about whether the practices employed at the facilities could ensure purity of drugs they made.

In February the FDA also said the plant in Paonta Sahib faked data and test results in approved and pending drug applications. Most of the falsified data involved required tests to prove drugs are stable over a certain time period, the agency said. The problems were discovered during a 2006 inspection, and included drug samples meant for required stability testing stored in refrigerators even though the samples should have been stored at room temperature. Logbooks also didn’t identify which samples were in the refrigerator or how long they had been there. The FDA halted the review of drug applications made at Ranbaxy’s Paonta Sahib plant in India because of the issue.

Chinese drywall lawsuits from around the country may be consolidated in a single jurisdiction. Some plaintiffs’ attorneys, as well as some defendants, are advocating that the Chinese drywall lawsuits be consolidated and transferred to the U.S. District Court for the Middle District of Florida, Fort Myers Division, which is located in the epicenter of the Chinese drywall problem.

Homeowners in at least 16 states have complained that fumes from Chinese-made drywall produce a “rotten eggs” odor and cause metals, such as air conditioning coils, to corrode. The fumes have also been associated with respiratory and sinus problems in some residents. According to a recent Wall Street Journal article, the U.S. imported roughly 309 million square feet of drywall from China during the housing boom from 2004 to 2007. While the first complaints about the material came from Florida, homeowners in many other states – including Virginia, Mississippi, Louisiana and North Carolina – have reported problems.

Earlier this month, the Environmental Protection Agency (EPA) released results of tests it conducted that compared Chinese drywall to American-made material. The tests found sulfur and two organic compounds associated with acrylic paint in the Chinese drywall that were not present in the American wallboard. The agency said more testing is needed to determine if any of the compounds found in the Chinese drywall are responsible for problems reported by homeowners.

The Chinese drywall problem has spawned scores of lawsuits in both federal and state courts. Parker Waichman Alonso LLP, a law firm in Bonita Springs, Florida filed the first federal class action on behalf of drywall victims in January.

Earlier this week, the Judicial Panel on Multidistrict Litigation (JPML) in Louisville, KY heard oral arguments requesting that all pending Chinese drywall cases filed around the country be consolidated and transferred to one jurisdiction. Parker Waichman Alonso LLP was among those who argued that the U.S. District Court for the Middle District of Florida, Fort Myers Division was the appropriate jurisdiction for the drywall litigation. According to attorney Jordan Chaikin, the firm favors this venue because Southwest Florida was the site of the first Chinese drywall complaints.

According to Chaikin, some of the main domestic defendants involved in the Chinese drywall litigation – namely U.S Gypsum and L&W Supply Co. – support Parker Waichman Alonso LLP’s choice of forum in the Middle District of Florida. A Transfer Order from the Panel is expected by mid-June.

The Judicial Panel on Multidistrict Litigation of the United States Courts was created in 1968. Since then, it has consolidated hundreds of thousands of lawsuits that involved high numbers of plaintiffs, including litigation over asbestos, breast implants and other matters. A multidistrict litigation (MDL) allows all cases to be coordinated under one judge for pretrial litigation to avoid duplicative discovery, inconsistent rulings and to conserve the resources of the parties, witnesses and the court. When lawsuits are consolidated as an MDL each retains its own identity. If the MDL process does not resolve the cases, they are transferred back to the court where they originated for trial.

A new study is warning about the negative effects of drinking too much cola. It seems that consuming cola in large amounts can drop blood potassium levels, which can lead to a muscle problem called hypokalemia, reported HealthDay News.

Symptoms of hypokalemia include anything from mild weakness to serious paralysis said HealthDay News, citing the researchers who conducted the study. Canada.com said symptoms can also include cramping, palpitations, and nausea, with extreme cases causing potassium deficiency, which can lead to cardiac problems and “profound paralysis.” The team looked at people who drank between two and nine liters of cola daily, including two pregnant women who required hospital admission because of low potassium levels, said HealthDay News.

Of the two, one was a 21-year-old woman who reportedly drank up to three liters of cola daily and “complained of fatigue, appetite loss, and persistent vomiting,” said HealthDay News. Results of her electrocardiogram revealed a heart blockage; she also had low potassium levels said HealthDay News, citing the researchers. The other woman drank up to seven liters of cola daily over a period of 10 months and suffered from low potassium levels and “increasing” muscle weakness, HealthDay News reported.


Canada.com note that, according to the study, hypokalaemia can be caused by excessive consumption of glucose, fructose, and caffeine, all of which are present in most cola drinks. Both women recovered fully when they stopped consuming cola and were placed on oral or intravenous potassium, said HealthDay News.

“We are consuming more soft drinks than ever before, and a number of health issues have already been identified including tooth problems, bone demineralization, and the development of metabolic syndrome and diabetes,” said Dr. Moses Elisaf, of the University of Ioannina, in a news release, quoted HealthDay News. Dr. Elisaf also pointed out that evidence is leading researchers to conclude that consuming excessive amounts of cola can lead to the potentially serious muscle disorder.

Dr. Elisaf noted that the study revealed that “… in most of the cases we looked at for our review, caffeine intoxication was thought to play the most important role. This has been borne out by case studies that focus on other products that contain high levels of caffeine but no glucose or fructose.” Elisaf added that cola drinks without caffeine can be problematic since, “caffeine-free cola products can also cause hypokalemia because the fructose they contain can cause diarrhea,” quoted HealthDay News.
Canada.com also wrote that a review of the research revealed that even small changes in potassium levels can significantly change “the body’s cardiovascular and neuromuscular” system functioning.

Clifford Packer from the Louis Stokes Cleveland VA Medical Center in Ohio and who was published in the same journal as the study, stated in his commentary that physicians should be aware that, “Cola drinks need to be added to the physician’s checklist of drugs and substances that can cause hypokalaemia,” reported Canada.com.

The study and commentary are published in next month’s issue of the International Journal of Clinical Practice.

Simponi , a new rheumatoid arthritis drug, can cause severe and potentially fatal fungal infections, according to a new warning released yesterday by the Food & Drug Administration (FDA). Because of this risk, the agency said that when making a decision to use Simponi, doctors must balance the potential benefits with the potential risks of therapy based upon a patient’s individual need.

Simponi is one of a class of drugs known as TNF-alpha blockers. Such medications work by suppressing the immune system. Other drugs in this class include Humira, Cimzia, Enbrel, and Remicade. Simponi was only approved in April as a treatment of adult patients with: moderate to severe rheumatoid arthritis in combination with methotrexate, psoriatic arthritis (either alone or in combination with methotrexate), and ankylosing spondylitis.

It has long been known that people taking TNF-alpha blockers run a risk of developing opportunistic infections, including histoplasmosis, an infection caused by the fungus Histoplasma capsulatum. The FDA also has received reports of cases of coccidioidomycosis and blastomycosis, including deaths, in patients treated with TNF-alpha blockers. Last fall the FDA ordered the makers of TNF-alpha blockers to strengthen the existing warnings about opportunistic fungal infections linked to the drugs.

A “Dear Healthcare Professional” letter issued by Centocor Ortho Biotech, Inc. advises doctors to carefully review Simponi’s prescribing information, which includes important information about the risk of serious infections including TB and invasive fungal infections, such as histoplasmosis, in a Boxed Warning.

The letter also warns that invasive fungal infections are not consistently recognized in patients taking TNF-alpha blockers. This has resulted in delays in appropriate antifungal treatment, sometimes even resulting in death. For patients who reside or travel in regions where mycoses are endemic (eg, Ohio and Mississippi River valleys and southwestern United States), invasive fungal infection should be suspected if they develop a serious systemic illness, the letter warns.

The letter also advises that patients be encouraged to report signs of infection and be closely monitored during and after treatment with Simponi and other TNF-alpha blockers for the development of invasive fungal infection. Signs and symptoms of such disorders include fever, malaise, weight loss, sweats, cough and dyspnea, pulmonary infiltrates on X-ray or serious systemic illness. TNF-alpha blockers should be discontinued in patients who develop such symptoms, and they should undergo a complete diagnostic workup. Once the infection has cleared, use of Simponi and other TNF-alpha blockers may be restarted based on a reevaluation of risks and benefits.

The relationships and finances exchanged between Industry and researchers have long been making the news and point to a bias in which patients are often not the prime concern. In a growing trend of reports of physicians and researchers failing to disclose Industry payments, the Wall Street Journal just released an article about prominent spine surgeon Jeffrey Wang who has joined the ranks of these physicians.

Wang, chief of spine surgery from the University of California, Los Angeles (UCLA) neglected to disclose payments from medical companies while conducting research for them, said the Journal, citing records obtained by congressional investigators. UCLA’s Jeffrey Wang, kept quiet about $459,500 he received from 2004 through 2007, said the Journal, according to a May 21 letter it reviewed from Senator Charles Grassley (Republican-Iowa) to UCLA’s chancellor. According to Grassley, said the Journal, Dr. Wang “consistently checked no” on the forms in the area asking if income exceeding $500 was received from companies funding Wang’s clinical research.

Grassley and others have spearheaded investigations into the negligence surrounding the reporting of these relationships. Those concerned say the conflicts can affect critical decisions about research and subsequent treatments, said the Journal.

Because of Grassley’s investigations, restrictions have been put in place that limit the money researchers accept from Industry, publicize funds received, and restrict consultant and speaker roles, said the Journal in a prior report. A number of states—Maine, Massachusetts, Minnesota, Vermont, and West Virginia—now have laws that say medical companies must report payments made to in-state doctors; a bill has been sponsored by Grassley and others, requiring national disclosure, said the Journal.

Dr. Wong was paid by Medronic Inc. ($186,700 from 2004 through 2007), Johnson & Johnson’s DePuy unit, and FzioMed Inc., said the Journal, according to Grassley. Funds included product royalties and speaking and consulting fees. No monies were reported to UCLA until Grassley asked for Wang’s disclosure forms, said Grassley, reported the Journal. In California, state university researchers must disclose “financial ties to nongovernmental entities funding their work,” said the Journal.

Conflicts of interests can result in fines, fund freezes, and future grant loss, said the Atlanta Journal-Constitution in an earlier report. To help ensure no conflict-of-interest opportunities present themselves, the government mandates all such conflicts be reported by clinical researchers responsible for reviewing medications in advance of drug companies applying for U.S. Food and Drug Administration (FDA) approval. But, earlier this year, the Inspector General’s Office said the FDA is not reliable when it comes to finding drug research conflicts, a huge issue these days between medical professionals and industry.

Last year, prominent Emory University professor Charles Nemeroff lost his chairmanship following controversy over payments he received from drug companies. In December, following an internal investigation, Nemeroff stepped down as head of the school’s Department of Psychiatry and Behavioral Sciences, a position he held since 1991. Since, Nemeroff and the university have been the subject of a Grassley-urged federal investigation into Nemeroff’s highly compensated activities with Industry.

Joseph Biederman’s activities also made for a well-publicized conflict of interest case. A prominent Harvard University psychiatrist, Biederman promised to deliver positive results to major drug maker Johnson & Johnson before the start of some clinical trials for Risperdal (Risperidone), an atypical antipsychotic medication, prompting another investigation by the Senator.

Some statins —drugs that lower blood cholesterol levels—have been linked to various adverse events. Now, an emerging study has found that the medications might be negatively affecting patients with Multiple Sclerosis (MS), reports Science Daily, especially in those patients taking high daily doses of statins.

MS is an autoimmune disease of the central nervous system (CNS) and involves the immune cells attacking the nerve fibers’ protective insulation, known as the myelin sheath, as well as myelin-producing cells of the CNS, called oligodendrocytes, explained Science Daily. These activities cause demyelination, which results in damage that hinders “the nerve cell’s ability to transmit signals throughout the nervous system,” Science Daily added.

Researchers looked at the effects of statins on myelin repair in mice and found that statins inhibit remyelination (myelin repair) in the central nervous system, said Science Daily. The study was conducted at the Montreal Neurological Institute (MNI), McGill University; the findings were published in The American Journal of Pathology. The study looked at how simvastatin—a statin in clinical trials—affected myelin in the brain and also looked at the remyelination process, said Science Daily.

The researchers discovered that “simvastatin has in fact, a slightly deleterious effect on myelin,” said Dr. Miron, quoted Science Daily. Dr. Veronique Miron is a post-doctoral fellow at the MNI and is a lead investigator in the study. Dr. Miron explained that during remyelination, myelin and oligodendrocyte production decreases with simvastatin, which means that simvastatin hampers CNS remyelination. This is of note because, in early MS, when an immune system attack on myelin occurs, the oligodendrocyte progenitor cells or stem cells in the CNS work to repair the damage, said Science Daily. If the myelin damage is not reversed, the degeneration continues and worsens.

Other statins have also been in the news for some time over various side effects. For instance, Baycol (generic: cerivastatin) was approved in the United States in 1997, but was pulled from the market in August 2001 because it was linked to Rhabdomyolysis, which caused 31 deaths in the United States. Rhabdomyolysis is a condition that causes muscle-cell breakdown (atrophy) and leads to muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting and is also known to be life threatening. Rhabdomyolysis also injures the kidneys because of the toxic effects of the contents of muscle cells. Myoglobin is an iron-containing pigment found in the skeletal muscle. When the skeletal muscle is damaged, myoglobin is released into the bloodstream and is filtered out by the kidneys. Myoglobin may occlude the structures of the kidney, causing damage such as acute tubular necrosis or kidney failure. Myoglobin breaks down into potentially toxic compounds, which also cause kidney failure.

Crestor, another statin, has also been linked to kidney damage, kidney failure, and Rhabdomyolysis. On October 22, 2004, the consumer group Public Citizen said 29 patients who took AstraZeneca’s cholesterol drug Crestor developed kidney damage and also noted that the rate of reported kidney problems is approximately 75 times higher with Crestor than with all other drugs in the same class combined. The FDA approved Crestor in August 2003 following a delay over safety concerns.

We have long been writing about the serious side effects associated with some popular dementia drugs. Now, ScienceDaily is reporting that these adverse effects could be placing the elderly at risk, citing Sudeep Gill, a geriatrics professor at Queen’s University who is also an Ontario Ministry of Health and Long-term Care Career Scientist working at Providence Care’s St. Mary’s of the Lake Hospital in Kingston.

Aricept, Exelon, and Reminyl are in a class of drugs called cholinesterase inhibitors and are typically prescribed for Alzheimer’s disease patients and patients with related dementias, said Science Daily, explaining that the drugs increase the brain chemical thought to aid in memory. The drugs also seem to decrease heart rates and prompt fainting, said Science Daily, noting that the enormity of the issue was not previously understood.

“This is very troubling, because the drugs are marketed as helping to preserve memory and improve function. But for a subset of people, the effect appears to be the exact opposite,” Dr. Gill said, quoted Science Daily.

Dr. Gill and his team found, based on province-wide data, that patients taking cholinesterase inhibitors experienced the following over those patients not on these drugs: Hospitalizations for fainting, almost twice as often; lowered heart rates occurred 69 percent more often; increased chance of being permanently implanted for pacemakers, about 49 percent more often; and increased risk of hip fractures, 18 percent more often, said Science Daily. Sadly, said Dr. Gill, cholinesterase inhibitors are one of the few effective dementia treatments currently available, reported Science Daily.

Slowed heart rate from cholinesterase inhibitors could cause someone to faint and “suffer fall-related injuries such as a broken hip,” said Science Daily, which could be dangerous, even deadly for the elderly. Unfortunately, many doctors do not know about the link between these dementia drugs and the dangerous side effects, noted Science Daily. A serious problem because, for instance, patients on dementia drugs who faint could be implanted with a pace maker, which would be an unnecessary and dangerous procedure, especially in the frail and elderly, Science Daily pointed out.

The findings are published in the journal, Archives of Internal Medicine and involved scientists from the Institute for Clinical Evaluative Sciences, the University of Toronto, and Harvard University, said Science Daily.

We have reported that the U.S. Food and Drug Administration (FDA) was examining the results of a study on Aricept, which examined 974 patients suffering from dementia. There were 11 deaths among patients taking Aricept as compared to no deaths occurring among those taking the placebo. Medical experts say that the study should not be written off and that it might indicate that Aricept and similar drugs increase the risks of heart disease, according to a prior New York Times report. Also, data from two clinical trials indicated that people taking Reminyl (Generic: Galantamine) have a much higher death rate than those taking a placebo. The trials, involved approximately 2,000 patients in 16 countries.

We recently reported that President Barack Obama announced a Cabinet-level food safety group, plans to increase the number of U.S. Food and Drug Administration (FDA) food inspectors, and plans to bring food safety labs to current standards. Now, according to the Washington Post, proposed food safety legislation was just introduced in the House.

The bill, said the Washington Post, which was introduced by the Energy and Commerce Committee Chairman Henry A. Waxman (Democrat-California) and Representative John D. Dingell (Democrat-Michigan), would give the FDA expanded authority such as the ability to recall tainted food—a power the agency does not currently hold. The FDA would also be able to “quarantine” questionable food; impose civil penalties and increase criminal sanctions on violators; and mandate private laboratories hired by food manufacturers report any food contamination to the government, the paper added.

The FDA has been routinely criticized for lax oversight on drug safety, medical device safety, and food safety issues that include the historic and massive salmonella outbreak linked to horrendous conditions at the Peanut Corporation of America (PCA). That outbreak sickened over 900 people and was linked to at least nine deaths; 46 states were involved and over 3,000 products were recalled, making it the largest food recall in American history. According to the Washington Post, federal officials believe that tens of thousands more people were likely sickened.

Although a number of other deadly and widespread outbreaks have plagued the nation in recent years, it was the disgusting conditions and ongoing negligence involved in the PCA debacle that forced serious food safety reform. The scandals revealed during the outbreak highlighted myriad problems with current food safety processes and prompted attention from President Barack Obama, said the Washington Post; the president continues to take steps to correct the issues hampering the beleaguered agency.

“This is a major step forward,” said Erik Olson, director of food and consumer product safety at the Pew Charitable Trusts, quoted the Washington Post. “This has really been needed for decades. We’re still operating under a food and drug law signed by Teddy Roosevelt,” Olson added.

The bill addressed a number of issues that came to light during the PCA Salmonella fiasco in which PCA knowingly shipped Salmonella-contaminated nuts and nut products to a number of manufacturers who, then, used the toxic ingredients in untold numbers of consumer food products, said the Washington Post. The scandal also revealed that PCA’s Georgia plant had not been inspected for seven years and its Texas plant was operating under the radar of state and federal officials, said the Washington Post, which added that PCA-hired private laboratories detected contamination on numerous occasions, but never reported the problems.

Also, noted the Washington Post, those responsible for the clean up had countless problems trying to figure out what products were involved. Because of this, the bill has a provision requiring all those involved in the food chain to maintain records to enable appropriate and speedy trace-back within the chain in the event of an outbreak of any size, explained the Washington Post.

Although trade group The Grocery Manufacturers Association supports a lot of the proposal, it does not support a proposed $1,000 annual registration fee for food facilities, nor does it approve some tracing mandates, claiming the proposed requirements are financially prohibitive, said the Washington Post.

It seems that over 200 investors in Bernard Madoff’s

$65 billion Ponzi scheme are moving closer to recouping some of their lost funds, said ABC News, citing Irving Picard, the appointed bankruptcy trustee charged with liquidating Madoff’s assets.

Picard was hired by the Securities Investor Protection Corporation (SIPC) to recover some of the $65 billion Madoff’s investors lost to his scam. So far, Picard has been able to collect $1.22 billion as a result of his efforts.

Madoff pleaded guilty to 11 fraud counts on March 12. The former chairman of the NASDAQ stock exchange ran an investment advisory business for decades that was, in reality, a Ponzi scheme. Last November, Madoff told his investors his fund held over $64 billion, but in reality, it only held a mere fraction of that amount. Because Madoff’s Ponzi scheme went on for decades, it is suspected that he was far from the only person in his circle who knew of the swindle. It’s known that several people close to Madoff—including key employees, as well as his wife, sons, and brother—were among those close to him caught up in the probe.

According to an earlier Bloomberg.com report, Picard has filed several claw back lawsuits seeking a total of $10.1 billion in profits withdrawn by Madoff investors that he claims should have known of the fraud. Picard is also seeking about $735 million from Madoff customers outside of court. Sadly, in spite of these efforts, most experts expect that Madoff’s former investors will only recover pennies on the dollar.

ABC News reported that, as of this week, letters were issued to commit over $116 million to satisfy claims from the some 237 Madoff victims expected to receive up to $500,000 from the SIPC. This is part of the hardship program Picard initiated to reclaim Madoff’s assets on behalf of the disgraced financier’s victims. The program will enable individual victims experiencing significant financial hardship to file a special claim by July 2 that seeks “an accelerated federal insurance payment,” Picard announced, said USA Today previously, with each applicant eligible to qualify for up to $500,000.

Picard said his office has received close to 9,000 claims from swindled investors and called Madoff’s scam the “most complicated and far reaching financial fraud in U.S. history,” quoted ABC News.

Most recently, Picard reached a deal with Spain’s largest bank regarding investments two of its hedge funds made with the admitted Ponzi schemer. According to Bloomberg.com, Banco Santander will pay $235 million to Picard to avoid a lawsuit. Santander’s Optimal Investment Services unit operated the two hedge funds, Bloomberg.com said. Santander said its agreement with Picard did not imply any wrongdoing on its part.

As we reported previously, losses for Banco Santander’s clients were among the highest of any bank linked to Madoff’s investment advisory business. As a result of its Madoff’s investments, the bank’s clients lost more than $3.1 billion. Yet, just weeks before Madoff’s Ponzi scheme collapsed, managers at Banco Santander’s Optimal hedge fund investment arm were praising Madoff’s supposedly “impeccable” market timing. The massive losses prompted some Santander clients to file a class action lawsuit against the bank in Miami, charging it did not perform enough due diligence regarding its Madoff investments.

The Connecticut State House has agreed, in an overwhelming vote, to ban bisphenol A (BPA) from plastic containers used by children and babies, reports the Hartford Courant. The ban does not take effect until October 1, 2011 and involves only a limited array of products, according to the Courant.

This was the second BPA debate in the Connecticut State House in 2009. The Senate passed the bill in a 35-to-1 vote and the House passed it in a unanimous vote of 135-0. The ban now encompasses “reusable food and beverage containers, including containers of infant formula and baby food, reusable spill-proof cups, plastic sports bottles and Thermoses,” reported the Courant. The bill does not address products geared to the general population, beverage containers, and single-use jars and cans.

The bill’s prior version included a labeling requirement for containers not included in the ban. That version had passed House last month by 128-to-14; however the Connecticut Senate eliminated the requirement, forcing another House vote, explained the Courant. East Harford Democratic Senator Gary LeBeau said the requirement for labeling was “a little heavy-handed on business … another mandate on retailers and producers of bottles and cans,” quoted the Courant. The bill allows for existing inventory to be sold off.

As we previously reported, a newly released study confirmed what experts have long suspected – that containers made with BPA leach the chemical into the liquids being held, said the LA Times.

According to the Harvard School of Public Health, BPA exposure has been shown to interfere with reproductive development in animals and has been linked with cardiovascular disease and diabetes in humans. Despite industry’s arguments that BPA is safe at current dosages, the ever-present chemical, an estrogen mimicker, has also been linked to an increased risk of diseases or disorders of the brain, reproductive, and immune systems; problems with liver function testing; and interruptions in chemotherapy treatment. BPA is also associated with serious health problems based on 130 studies conducted in the past decade and newer research found BPA to have negative effects at “very low doses,” lower than the FDA’s current safety standards.

Most recently, studies revealed BPA seems to stay in the body longer than previously believed. BPA can be found virtually everywhere and is present in detectable levels in just about every human body. The highest levels are seen, noted the Chicago Tribune in a prior report, in the youngest Americans. A concern since BPA is known to leach in increased doses when containers made of the dangerous chemical are heated, as is often the case with baby bottles.

Meanwhile, the FDA continues to maintain BPA is safe despite that it relied solely on two industry-funded studies for its draft review, something for which the agency has long been criticized.

BPA is used in the manufacture of polycarbonate and other hard plastic products, including water and baby bottles, sippy cups, dental sealants and composites, and the linings used for canned foods, among many other common items. The journal Environmental Health Perspectives reported that in 2003, the majority—three-quarters—of the nearly two billion pounds of BPA used in the United States was for manufacture of polycarbonate resin.