Friday, June 28, 2013

Beware food supplements used by Athletes (Article from S.A.)

Worrisome news about supplements used by athletes:

Consumers are at risk of ingesting banned substances from supplements that do not label their ingredients completely, said Fahmy Galant, doping control manager at the South African Institute for Drug Free Sport (Saids). 

In South Africa, a survey by the Journal of the American Medical Association detected that 12 (40 percent) out of 30 over-the-counter supplements contained banned substances.
If a student who has ingested a banned substance is tested by his school or an independent organisation like Saids, he or she may be suspended from playing, said the Saids representative.
“It is extremely difficult for the average consumer to judge the quality and the value of the claims of dietary supplements,” said Heidi-Lee Robertson, business development manager for DSM Nutritional Products.

Zinc Oxide Used in Dietary Supplements Are Toxic

Interesting reading about Zinc Oxide:

A study in Biomedical and Environmental Services claims that zinc oxide is the most toxic nanoparticle compared to titanium dioxide, silicon dioxide, and aluminum oxide.

X.Q. Zhang and other researchers from the Southeast University in Nanjing, China conducted the study and found all tested all of the four above mentioned nanoparticles caused cellular mitochondrial dysfunctions, morphological modification and even apoptosis in human fetal lung fibroblasts. It was dose dependent, meaning that high high concentrations were related to high toxicity.

Compared with the other three types, zinc oxide was the most dangerous and toxic, according to the study. Zinc oxide, titanium dioxide, silicon dioxide, and aluminum dioxide are all used in processed foods and many dietary supplements. Zinc and titanium dioxides were the most commonly used, especially in sunscreen and cosmetic products dealing with the skin.

India: Governmentt Bans Diabetes Drug Actos

From India:

The government has banned the widely prescribed anti-diabetes drug pioglitazone in the wake of claimed health risks associated with the drug.

The decision to ban pioglitazone and its combinations will hit the Rs 700-crore market for such drugs and adversely impact a clutch of companies including Abbott, Sun Pharma, USV, Lupin, Ranbaxy and Wockhardt.

Pioglitazone combination is a bigger market than plain pioglitazone itself which is has posted a strong double-digit growth, with over 30 companies marketing the drug. The top-selling brands of posiglitazone include Pioz MF G and Pioz (USV), Gemer P (Sun Pharma), Tribet (Abbott), Tripride (Micro Labs) and Gluconorm PG (Lupin).

Wednesday, June 26, 2013

Lowlite Investments, Inc. d/b/a Olympia Pharmacy Announces a Voluntary Multi-State Recall of All Sterile Compounded Products

Lowlite Investments d/b/a Olympia Pharmacy ("Lowlite") today announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility assurance.
In the event a sterile product is compromised patients are at risk for serious and possible life threatening infections. To date, Lowlite has received no reports of injury or illness associated with the use of our sterile products. This voluntary recall is being conducted as a precautionary measure to ensure the sterility of our sterile products, and is being conducted with the full knowledge of the FDA.
Patients should experience little to no disruption in their pharmacy services as a result of this recall.
The recall includes all sterile products that Lowlite supplied to patients and offices of licensed medical professionals with a use by date of 09/25/2013 or earlier. A list of products is attached. Lowlite will be notifying customers by phone, fax, or mail to return the products to the pharmacy.

Advance Pharmaceutical Inc. Issues Voluntary Recall of One Lot of Enteric Coated Aspirin

Orange aspirin tablets. Flickr data (on upload...
Orange aspirin tablets. (Photo credit: Wikipedia)
Advance Pharmaceutical Inc. today announced that this firm is conducting a voluntary nationwide recall to the user level of the over-the-counter drug product, Rugby label Enteric Coated Aspirin Tablets, 81 mg, Lot 13A026. Advance Pharmaceutical Inc. first initiated the recall on June 17, 2013, after receiving a complaint about a bottle labeled as Enteric Coated Aspirin Tablets, 81 mg, actually containing Acetaminophen 500 mg tablets.
The product is indicated for the temporary relief of minor aches and pains and is packaged in bottles of 120 tablet with NDC 0536-3086-41 and UPC 3 0536-3086-41 9. The affected lot of Enteric Coated Aspirin Tablets is Lot 13A026 with Expiration Date 01-2015. The lot was manufactured and packaged by Advance Pharmaceutical Inc. under the label of Rugby Laboratories. Rugby Laboratories (Major Pharmaceuticals) distributed the product nationwide to wholesalers and retailers.
Consumers may be inadvertently taking Acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg which may cause severe liver damage to those who take other drugs containing acetaminophen, consumers who take 3 or more alcoholic drinks every day, or those who have liver disease. The labeled directions instructs patients to take 4-8 tablets every 4 hours, but not more than 48 tablets in 24 hours. Consumers who take 48 tablets daily of the defective product may be ingesting up to 24,000 mg of Acetaminophen, which is about six times the maximum recommended daily dose of acetaminophen (4,000 mg).

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FDA: Sex supplements contain hidden drugs

The names of the tainted products are: Reload, Get It Up, Super Cheetah, Cave Diver, Nights to Remember and X Zen Platinum. All of the products are marketed for sexual enhancement, and sold on various websites and in some retail stores, the FDA said.

All of the products were found to contain the drug sildenafil (sold under the brand name Viagra), and one was found to contain tadalafil (brand name Cialis). Sildenafil and tadalafil are prescription drugs used to treat erectile dysfunction. Sex supplements are not allowed to contain prescription drugs, and the drugs are not included on the products' labels.

Read more:

From the FDA:

The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Cave Diver,” a product promoted and sold for sexual enhancement on various websites and in some retail stores. 
FDA laboratory analysis confirmed that “Cave Diver” contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction (ED).  This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. 
Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. 

Strollers Recalled by Kolcraft Due to Projectile Hazard

Some quick recall information:

Name of product: Jeep Liberty Strollers

Hazard: The inner tube of the tire on the stroller can rupture causing the wheel rim to fracture and fly off as a projectile, posing a risk of bodily injury and property damage.

Name of product: Idea Baby Bath Seats
Hazard: The bath seats fail to meet federal safety standards, including the requirements for stability. Specifically, the bath seats can tip over, posing a risk of drowning to babies. 
Remedy: Consumers should immediately stop using the recalled bath seats. If purchased at a Buy Buy Baby store or online, consumers should return the bath seats to any Buy Buy Baby store to receive a store credit. If purchased at a Bed Bath & Beyond store, consumers should return the bath seats to the store where purchased to receive a store credit.
Consumer Contact: Buy Buy Baby, toll-free at (877) 328-9222 anytime, or online atwww.buybuybabycom or at, then click on Safety and Recalls at the bottom of the homepage of either site for more information. 
Recall Details
Units: About 34,000
Description: This recall includes Idea Baby brand infant bath seats. The recalled product is a bath seat designed for children five months to ten months old. The seat is made of pink or blue plastic and has four suction cups on the bottom. An oval-shaped arm rail runs from the seat back and connects two side posts and the seat front post. Two star-shaped spinning toys are on the front of the seat rail above the front post. Between the two spinning toys is a round, inset plastic disc with the words "," "Idea Baby" and "Made in Italy."
Incidents/Injuries: None have been reported.
Sold at: Buy Buy Baby and Bed Bath & Beyond stores and online at from September 2012 through April 2013 for about $40. 
Importer:  Liberty Procurement Co. Inc., of Union, N.J.
Manufactured in: Italy
The U.S. Consumer Product Safety Commission (CPSC) is still interested in receiving incident or injury reports that are either directly related to this product recall or involve a different hazard with the same product. Please tell us about your experience with the product on

Mother Sues Energy Drink Maker Over Teenager's Death

Monster Energy
Monster Energy (Photo credit: Wikipedia)
A California woman has sued Monster Beverage Corp., claiming her son's habit of drinking two 16 oz. cans of the company's energy drink caused him to die from cardiac arrest last year.

In March, a group of 18 doctors and scientists wrote a letter to the U.S. Food and Drug Administration, urging regulatory action to protect children and adolescents from energy drinks with high amounts of caffeine. The FDA announced a formal investigation on May 3 into the safety of caffeine-containing food products on children and adolescents. The FDA previously indicated that as many as five deaths between 2009 and 2012 might be linked to Monster's energy drink; another 13 were associated with 5-Hour Energy.
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Impax to get new CEO as it tries to right manufacturing issues

A team of outside experts has been taking steps to help Impax Laboratories get back on track after manufacturing issues sidetracked a key drug application and a key partnership with GlaxoSmithKline ($GSK). The company earlier this month said it would lay off 10% of its workforce to save money and now it says co-founder and CEO Larry Hsu is stepping down to make room for new leadership.

Read more: Impax to get new CEO as it tries to right manufacturing issues - FiercePharma Manufacturing
Subscribe at FiercePharma Manufacturing

Saturday, June 22, 2013

Beta Labs, LTD Announces Recall of Oxyphen, Phentalene, Phen FX, and Red Vipers

Beta Labs, LTD (“Beta”), dietary supplement retailer, is recalling Oxyphen XR Lot #s 200910 and 200911, Phentalene Lot # 58800512, Phen FX Lot # 1205129, and Red Vipers Lot # 1205128 (hereinafter referred to as the “Products”). The recall was initiated on June 15, 2013, after a review of recent FDA communications related to 1,3 dimethylamylamine (“DMAA”). The Products contain DMAA.
The UPC codes for each of the products are: Oxyphen XR, 70541 59974; Phentalene, 70541 59982; Phen FX, 29882 55980; Red Vipers, 29882 55981. The Products are all in capsule form.
DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. The Food and Drug Administration (FDA) has warned that DMAA is potentially dangerous to health. 

See Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems. A number of adverse effects associated with DMAA containing dietary supplements have been reported to the FDA. The FDA has also warned that DMAA is not a dietary ingredient and thus, is not Dietary Supplement Health and Education Act (DSHEA) compliant.    
This recall affects Oxyphen XR Lot #s 200910 and 200911, Phentalene Lot # 58800512, Phen FX Lot # 1205129, and Red Vipers Lot # 1205128. The products are in capsule form.

June 22 DMAA News: U.S seizes DMAA from GNC

Read more at the link. We have filed a case involving this ingredient, and we are investigating others.

The Justice Department, acting at the behest of the F.D.A., requested court-ordered seizures this week of both Jack3d and OxyElitePro from GNC warehouses in Leetsdale, Pa., and Anderson, S.C.
According to a complaint filed in Federal District Court in Pittsburgh, the F.D.A. conducted an inspection of the GNC warehouse in Leetsdale this month and collected physical samples, photographed the products and seized shipping records. After the inspection, F.D.A. officials notified GNC that the products were adulterated and being illegally held by the company. On June 11, the F.D.A. ordered GNC to detain the products.

Here is the Complaint filed in SC:

Thursday, June 20, 2013

Diet products contain dangerous drugs, FDA warns (Fat Zero)

Fat Zero sounds like a safe, natural product, containing bee pollen and other ingredients like green tea and lotus seed. But it also contains sibutramine, a prescription diet drug that was so dangerous it’s been pulled off the U.S. market, the Food and Drug Administration says.

The FDA issued warnings about a batch of similar slimming products – all claiming to be natural, and all containing not only sibutramine, but phenolphthalein, a laxative that’s also been pulled out of pills because it might cause cancer.

From the FDA:
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Fat Zero, a product promoted and sold for weight loss on various websites and in some retail stores.
FDA laboratory analysis confirmed that Fat Zero contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking. 
Laboratory analysis also confirmed that Fat Zero contains phenolphthalein. Phenolphthalein was an ingredient in some over-the-counter (OTC) laxative products until 1999 when FDA reclassified the ingredient as “not generally recognized as safe and effective.”

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Wednesday, June 19, 2013

Bethel Nutritional Consulting, Inc. Issues Voluntary Recall of Weight Loss Pills “Bethel 30”

Bethel Nutritional Consulting, Inc. was informed by the Food and Drug Administration (FDA) that a sample of Bethel 30 green capsule was collected and tested by FDA in April 24, 2013. The capsules tested positive for Sibutramine and Phenolphthalein. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The FDA has not approved Bethel 30, green capsules as drugs; therefore the safety and effectiveness of this product is unknown.

FDA advises that these products may pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
Bethel 30, green capsules are marketed as a Natural Herb for Weight Loss manufactured with a pharmaceutical & Nutraceuticals laboratory. Bethel 30 Herb Supplement is packaged in plastic white bottles containing 30 capsules per bottle and bears Lot #’s 120514, with EXP: 12/05/2014.

The lot 120514 is the only one subject to recall and it will not be distributed through, or retail in office.

The product was sold directly to individual customers in our New York, NY, sales office and online at The company discontinued total distribution. It sincerely regrets any inconvenience to our customers.

 Consumers should not consume Bethel 30, green capsules, Herb Supplement and should return it immediately to the place of purchase

FDA investigating long-acting Zyprexa shots after two deaths

The Food and Drug Administration says it is investigating the unexplained deaths of two patients in the wake of receiving intramuscular injections of the antipsychotic medication Zyprexa (generic name olanzapine). The patients died three to four days after receiving appropriate doses of Zyprexa Relprevv, which is designed to release slowly into the blood over two to four weeks and provide regular dosing for adults with schizophrenia.,0,6455639.story

From the FDA:

 The U.S. Food and Drug Administration (FDA) is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate).  The patients died 3-4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS).  Both patients were found to have very high olanzapine blood levels after death. High doses of olanzapine can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and reduced level of consciousness ranging from sedation to coma.

FDA is providing this information to health care professionals while it continues its investigation.  If therapy with Zyprexa Relprevv is started or continued in patients, health care professionals should follow the REMS requirements and drug label recommendations.  Patients and caregivers should talk to their health care professional(s) about any questions or concerns.

Under the REMS, patients are required to receive the Zyprexa Relprevv injection at a REMS-certified health care facility, to be continuously monitored at the facility for at least 3 hours following an injection, and to be accompanied home from the facility.  The Zyprexa Relprevv label contains warnings about the risk of post-injection delirium sedation syndrome (PDSS), a serious condition in which the drug enters the blood too fast following an intramuscular injection, causing greatly elevated blood levels with marked sedation (possibly including coma) and/or delirium.  In the clinical trials supporting the approval of Zyprexa Relprevv, cases of PDSS were observed within 3 hours after administration of Zyprexa Relprevv, but there were no deaths due to PDSS.  These two patients died 3-4 days after receiving an appropriate dose of the drug, and it is not clear whether they died from PDSS.

At this time, FDA is continuing to evaluate these deaths and will provide an update when more information is available.

Tuesday, June 18, 2013

Unexplained’ deaths from antipsychotic drug probed by FDA

English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)
The FDA says the two patients died three to four days after receiving injections of the drug, formally called Zyprexa Relprevv, and it is unclear what caused the deaths. The agency noted the drug contains warnings that it could cause post-injection delirium sedation syndrome in which the drug enters the bloodstream too fast and causes heavy sedation and possible delirium.
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Gwinnett Medical Center: Warns of Tuberculosis Exposure June 18, 2013

pictograms used by the United States National ...
 (Photo credit: Wikipedia)
More than 100 patients at Gwinnett Medical Center are being urged to get screened for tuberculosis after potentially being exposed to a hospital employee with an active case of the disease.
Officials at the Lawrenceville hospital said Tuesday that 133 patients were certain or likely to have had contact with the employee from Feb. 1 through May 10.
The patients have been sent letters urging them to contact the county health department to have a free skin test to determine whether they are at risk of developing TB.
“We want to emphasize that the risk of contracting TB from casual exposure is low, but it is important to do everything possible to rule out the possibility that any individual may have had a significant exposure,” Dr. Alan Bier, Gwinnett Medical Center’s chief medical officer, told a news conference at the hospital.
From the Georgia DPH:

Tuberculosis Section (TB)

Mission & Vision

The mission of the Georgia Tuberculosis (TB) Section is to control transmission, prevent illness and ensure treatment of disease due to tuberculosis. This is accomplished by the following:
  1. Identifying and treating persons who have active TB disease,
  2. Finding, screening and treating contacts, and
  3. Screening high-risk populations.
The TB Program has the legal responsibility for all TB clients in Georgia regardless of who provides the direct services. TB services are available to all who fall within the service criteria without regard to the client's ability to pay.

TB is a reportable disease in Georgia. All Georgia physicians, laboratories and other health care providers are required by law to immediately report clinical and laboratory confirmed TB cases under their care to Georgia public health authorities. TB cases may be directly reported to a County Health Department, a District Health Office, or to the state TB Program and TB Epidemiology Section of the Georgia Department of Public Health (DPH), which is responsible for the systematic collection of all reported TB cases in the state. Immediate reporting of TB cases enables appropriate public health follow-up of patients, including administration of directly observed therapy, monitoring TB treatment until completion, evaluating and screening contacts exposed to a TB case, and outbreak investigation and control.  TB cases in Georgia can be reported electronically through the State Electronic Notifiable Disease Surveillance System (SendSS), a secure web-based surveillance software developed by DPH, or by calling, mailing or faxing a report to public health authorities. Hospital infection control preventionists as well as public health nurses, outreach staff, epidemiologists, and communicable disease specialists involved in disease surveillance are encouraged to report TB through SendSS and register to become a SendSS user by logging into the system’s Web site at: then selecting TB from the list of reportable diseases.

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Sunday, June 16, 2013

More Children Poisoned By Parents' Prescription Drugs

Children are at risk not just from opioid painkillers like Vicodin and OxyContin, which most parents know need to be kept away from kids.
Seemingly innocuous medications for high cholesterol, diabetes and angina are sending children and teenagers to the emergency room. The risk was highest for children 5 and younger, who might pick up a pill from the floor and try it.Diabetes drugs and beta blockers caused the highest rate of emergency room visits, higher even than for opioids.

Statins linked to muscle pain

Researchers compared two groups of similar people enrolled in military health insurance and found those taking a statin were about 10 percent more likely to have muscle pain, sprains or strains.
Past studies have tied the popular cholesterol drugs to muscle weakness as well as the rare muscle-wasting disease rhabdomyolysis.

The new study expands on those findings and suggests the muscle-related side effects of statins might be broader, researchers said. However, they don't prove statins caused the pain and injuries seen among some patients.

FDA finds fungal, bacterial contaminants in Newbern pharmacy's steroid medicine

Both bacterial and fungal contaminants have been detected in unopened vials of drugs made by Main Street Family Pharmacy, the U.S. Food and Drug Administration said Thursday, providing the first direct evidence that the pharmacy is responsible for a new outbreak involving a widely used steroid medication.
So far, methylprednisolone acetate from the Newbern, Tenn., pharmacy has sickened 24 people in Illinois, North Carolina, Florida and Arkansas. This is the same medicine previously made by Massachusetts-based New England Compounding Center that has sickened 745 people in the United States with 58 deaths. The most serious consequence of that outbreak, which was first publicly reported on Oct. 1, 2012, have been cases of fungal meningitis.

Da Vinci Robotic Litigation

The Da Vinci Surgical Robot is a massive machine operated by a surgeon from a console with joystick-like controls. It was designed to give surgeons a range of movement greater than the human hand, and allows them to perform abdominal surgeries without cutting open the stomach. During a Da Vinci procedure, robotic arms are placed in the patient to burn away tissue, so a diseased organ can be removed. Ideally, use of the Da Vinci Surgical System in minimally invasive surgery should lead to less blood loss, much smaller scars and a faster recovery for the patient.
A single Da Vinci Surgical Robot can cost over a $1 million, but their high cost has not deterred hospitals from investing in this technology. According to a report published by the Chicago Tribune in February 2012, 250,000 hysterectomies and prostate removal surgeries were done with the Da Vinci system in 2011. Surgeons are now expanding use of the machines in other procedures, from gastric bypasses to thyroid cancer surgeries. It was recently approved by U.S. regulators for gall bladder surgery. Unfortunately, few randomized studies have been conducted to demonstrate that patients do best if procedures are performed with the Da Vinci. Regulation of such devices by the U.S. Food & Drug Administration is also light, the report said.
According to The Wall Street Journal, Intuitive Surgical has marketed the Da Vinci to hospitals as a way for them to increase their revenues and gain market share. Critics have also expressed concerns about the way surgeons are trained on the Da Vinci. When a hospital purchases a robot, Intuitive Surgical pays for a two-day training course for two surgeons. 
Several Da Vinci Surgical Robot lawsuits involving Da Vinci Surgical Robot procedures allege that patients have suffered serious, and even deadly, injuries including.
  • Surgical Burns to Arteries or Organs
  • Peritonitis (painful and tender inflammation of the lining of the abdomen)
  • Sepsis
  • Excessive bleeding
  • Burning of nearby organs including the intestines
  • Punctured blood vessels, organs or arteries
  • Burns and/or tears of the intestines
  • Severe bowel injuries
  • Punctured or cut ureters
  • Vaginal cuff dehiscence (reopening of the incision made to remove the uterus and cervix during a hysterectomy)
  • Additional Surgical Procedures Following Robot Surgery


Each month the Court in Boston holds a status conference. Here's a recent Order regarding the Motions to Transfer:

Tuesday, June 04, 2013

6/4 Newbern Pharmacy Infections: Three more die in fungal meningitis outbreak

Three people from Virginia have died from fungal meningitis, increasing the nationwide death toll to 58 in the ongoing outbreak that has sickened 745, the U.S. Centers for Disease Control and Prevention said Monday.

The CDC is also tracking another outbreak linked to the same medicine that has sickened 24 people in four states with what have, so far, been less-serious illnesses. The second outbreak involving methylprednisolone acetate is from medicine made by Main Street Family Pharmacy in Newbern, Tenn.

Iodide supplement Tri-Quench nearly killed him, man claims

Curtis Farber says that because of the "Tri-Quench" iodide product, he will have to take thyroid supplements for the rest of his life.

Farber's suit names among others the Tahoma Clinic, the Scientific Botanicals Co. and Wright's wife, Courthouse News reported.

Bayer to Face Lawsuit Over 'One A Day' Disease Claims

Bayer makes unsubstantiated and illegal claims that One A Day multivitamins can prevent various diseases, according to the Center for Science in the Public Interest.

Read more here:

FDA: Ban Gingko Biloba Says a Consumer Group

A study in March by the National Toxicology Program found that the popular dietary supplement gingko biloba caused cancer in lab animals, and, as a result, the Center for Science in the Public Interest is urging the Food and Drug Administration to ban i

Read more: