Wednesday, April 25, 2012

Canada News on Actos (April 2012)

Health Canada, the nation’s public health department, officially warned diabetes patients of the increased risk of bladder cancer that is possible for those taking Actos.  The labeling on this medication in Canada will also receive changes to reflect that cancer warning.  Actos (pioglitazone hydrochloride) is authorized for use by Canadian patients with Type 2 diabetes who cannot control their blood sugar with just diet and exercise. From HC:

 CTOS (pioglitazone hydrochloride) is an antidiabetic medication authorized in Canada to control blood sugar levels in people with type 2 diabetes whose blood sugar levels have not been controlled by diet and exercise. ACTOS may be used alone or in combination with other diabetes drugs (sulfonylurea or metformin).
  • New findings reveal that there is a potential increased risk of bladder cancer in patients treated with ACTOS.
  • ACTOS should not be used if patients:
    • have or have had bladder cancer
    • have blood or a red colour in their urine
  • Blood or a red colour in urine should be investigated before starting pioglitazone therapy. Patients prescribed pioglitazone are also advised to seek medical attention if during treatment, they have blood or a red colour in their urine, an increased need to urinate, or pain while they urinate, as these may be symptoms of bladder cancer.
  • Risk factors for bladder cancer should be assessed before starting pioglitazone (risks include age, smoking, family history of bladder cancer, exposure to chemicals in the workplace, to certain cancer treatments and radiation therapy).

FDA's Adverse Events Reporting System Highlights Several Drugs

Just reported today is new from the FDA regarding adverse events. Please note the FDA initial language:

FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.

Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) October - December 2011 
Product Name: Active Ingredient (Trade) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information
(as of February 15, 2012)
Death from intrathecal administration (medication error)The Dosage and Administration and Contraindications sections of the labeling for Velcade were updated January 2012, to include fatal events with intrathecal administration.
Bortezomib (Velcade) Labeling approved January 23, 2012 (PDF - 2.22MB)
Brentuximab vedotin
Progressive multifocal leukoencephalopathy (PML)FDA Drug Safety Communication
The Boxed Warning and Warnings and Precautions sections of the labeling for Adcetrus were updated January 2012, to include PML.
Brentuximab vedotin (Adcetrus) Labeling approved January 13, 2012 (PDF - 217KB)
Fluoroquinolone productsPeripheral sensorimotor neuropathyFDA is continuing to evaluate this issue to determine if the current labeling, which contains information about peripheral sensorimotor neuropathy, is adequate.
Gabapentin HCl
Increase in blood creatine phosphokinase levels and rhabdomyolysisFDA is continuing to evaluate these issues to determine the need for any regulatory action.
Gadolinium-based contrast agents (GBCA)
Acute kidney injuryFDA is continuing to evaluate this issue to determine if the current labeling, which contains information about kidney injury, is adequate.
Iloprost inhalation solution
HemoptysisFDA is continuing to evaluate this issue to determine the need for any regulatory action.
Loperamide HCl-containing products
PancreatitisFDA is continuing to evaluate this issue to determine the need for any regulatory action.
Magnesium sulfate for injectionFetal skeletal demineralization, hypermagnesemia, and other bone abnormalities with continuous long-term use in pregnant women.FDA is continuing to evaluate these issues to determine the need for any regulatory action.
Milnacipran HCl
Homicidal ideationFDA is continuing to evaluate this issue to determine the need for any regulatory action.
Anaphylaxis and infusion reactionsFDA is continuing to evaluate this issue to determine the need for any regulatory action.
Phenytoin (Dilantin) and non-depolarizing neuromuscular blocking agentsDrug interactions resulting in decreased effectiveness of the non-depolarizing neuromuscular blocking agentFDA is continuing to evaluate this issue to determine the need for any regulatory action.
Polyethylene Glycol (PEG) 3350 over-the-counter oral laxative
Neuropsychiatric eventsFDA decided that no action is necessary at this time based on available information.
Proton pump inhibitors (PPIs)
Over-the-counter (OTC) products
Clostridium difficile-associated diarrheaFDA Drug Safety Communication
FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Rubidium Rb 82 generator
Unintended radiation exposure to strontium isotopes following myocardial imaging scans.FDA Drug Safety Communication
CardioGen-82 was voluntarily recalled by the manufacturer in July 2011; a return to the U.S. market is planned.
The Boxed Warning, Dosage and Administration, and Warnings and Precautions sections of the labeling for CardioGen-82 were updated February 2012, to include information about unintended radiation exposure.
Rubidium Rb 82 generator (CardioGen-82) Labeling approved February 8, 2012 (PDF - 465KB)
Sorafenib tosylate
Osteonecrosis of the jawFDA is continuing to evaluate this issue to determine the need for any regulatory action.
Serious skin reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson Syndrome (SJS)FDA is continuing to evaluate this issue to determine the need for any regulator

Tuesday, April 24, 2012

FDA Warning Letters for April

Here is the letter to: Societe Fromagere de Bouvron:  

The U.S. Food and Drug Administration (FDA) inspected your cheese processing facility located at Route de Fay-de-Bretagne, BP 7, 44130 Bouvron, France on December 5, 2011. During that inspection, we found that your firm had a serious violation of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Parts 110). This inspection resulted in FDA's issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviation found at your firm. Upon request from our office via email on March 15, 2012, you submitted testing records and a picture of the equipment used as a pressure plate.

We have assessed that response and find it inadequate to alleviate our concerns with that piece of equipment. Failure to comply with the requirements of 21 CFR 110 renders your cheese products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) in that they have been prepared, packed, or held under insanitary conditions whereby the cheese may have been contaminated with filth or may have been rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at

Your firm's significant deviation continues to be as follows:
Your firm does not use plant equipment materials, namely the foam rubber-type material used with the pressure plates, that allow for adequate cleaning to comply with 21 CFR Part 110.40(a). Specifically, the pressure plates that are used to compress cheese curds within the equipment used to form the cheese (i.e., the cheese mold) have lower pad surfaces that are made of a foam rubber-type material in which our investigator observed small pores. These pads make contact with the top of the cheese as pressure is applied. The top of the equipment is made, in part, of a fine screen material, thus exposing the cheese curds within the equipment to potential microbial contamination from the foam rubber-type material underneath the pressure plates. Although you conduct periodic testing for Listeria spp. in your cheese products, you are still required under the CGMP regulations to only use materials that can be adequately and suitably cleaned.

FDA adds sexual side effects warning to baldness drug Propecia

Merck's baldness drug Propecia is taken by many American men with thinning hairlines. The drug, known generically as finasteride, is also sold by Merck as a different pill Proscar to treat an enlarged prostate. The U.S. Food and Drug Administration has announced label changes for both drugs, saying they could cause sexual side effects in the men who take them.

Monday, April 23, 2012

Novartis MS Drug To Carry Stronger Safety Warning

Europe's drug regulator   seeks stronger warnings for Gilenya after it concluded a review of the multiple-sclerosis pill, prompted by reports of heart problems and the death of a patient who took the drug.
The decision by London-based European Medicines Agency, the body responsible for licensing the pill in Europe a year ago, lifts a cloud of uncertainty from Gilenya, which Novartis touts as a potential blockbuster.
The EMA said the drug's existing warnings need to be strengthened, and said doctors shouldn't prescribe Gilenya to patients with a history of heart problems. In such cases, the patients' heart activity needs to be monitored at least overnight, the EMA said, while those starting treatment should have a heart check before and be monitored for six hours after the first dose.
Novartis will add a similar warning to the package inserts of drugs sold in the U.S., following separate discussions with the Food and Drug Administration.

FDA Drug Safety Communication: New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna)

The U.S. Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations should not be used (are contraindicated) in patients with diabetes.  In addition, a new warning is being added to avoid use of these drug combinations in patients with kidney impairment. The labels for the aliskiren drugs are being updated based on preliminary data from a clinical trial, “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).”
A list of medicines containing aliskiren is found in the Drug Facts box.  Lists of approved ACEIs and ARBs are found in Tables 2 and 3.
In ALTITUDE, the risks of kidney (renal) impairment, low blood pressure (hypotension), and high potassium blood levels (hyperkalemia) in a group of patients taking aliskiren plus an ARB or ACEI increased relative to a group of patients taking placebo plus an ARB or ACEI.  The preliminary data from ALTITUDE also demonstrated a slight excess of cardiovascular events (death or stroke) in the aliskiren group however,  FDA has reached no definite conclusion regarding an actual link between these drugs and death or stroke. FDA will evaluate the final trial results as well as results from other aliskiren trials and will communicate any new information when it becomes available.
The following recommendations are being added to the drug labels for aliskiren-containing products as of 4/20/12:
  • A new contraindication against the use of aliskiren with ARBs or ACEIs in patients with diabetes because of the risk of renal impairment, hypotension, and hyperkalemia.
  • A warning to avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment (i.e., where glomerular filtration rate [GFR] < 60 mL/min). 

A Trio of Sexual Enhancement Products Get FDA's Attention

A trio of products sold over the counter have caught the eye of the FDA. It looks like companies see the desire for men to buy these products, and they take illegal shortcuts to make them. 

RigiRx Plus” Contains Undeclared Drug Ingredient

The Food and Drug Administration (FDA) is advising consumers not to purchase or use “RigiRx Plus,” a product for sexual enhancement manufactured by Enhance Nutraceutical, and sold on various websites, including 
FDA laboratory analysis confirmed that “RigiRx Plus” contains aminotadalafil. Aminotadalafil is an analog of tadalafil, an FDA approved prescription drug used to treat Erectile Dysfunction (ED). This drug 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.

ZenMaxx” Contains Undeclared Drug Ingredient

The Food and Drug Administration (FDA) is advising consumers not to purchase or use “ZenMaxx,” a product for sexual enhancement manufactured by Enhance Nutraceutical, and sold on various websites, including
FDA laboratory analysis confirmed that “ZenMaxx” contains aminotadalafil. Aminotadalafil is an analog of tadalafil, an FDA approved prescription drug used to treat Erectile Dysfunction (ED). This drug 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.

X Rock

The Food and Drug Administration (FDA) is advising consumers not to purchase or use “X-Rock,” a product for sexual enhancement manufactured by CRM Laboratories and sold on various websites, including  FDA laboratory analysis confirmed that “X-Rock” contains sildenafil and hydroxythiohomosildenafil.  Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).  These drugs 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. 

Friday, April 20, 2012

Hospira Announces a Nationwide Voluntary Recall of One Lot of Morphine Sulfate Injection, USP 4 MG/ML, (C-II) 1 ML Fill in 2.5 ML Carpuject

Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary user level recall of one lot of Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1258-30, due to a customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume.
Opioid pain medications such as morphine have life-threatening consequences if overdosed.  Those consequences can include respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

The affected product is a prefilled glass cartridge for use with the Carpuject™ Syringe system.  The affected lot number is 10830LL. The expiration date is April 1, 2013. Morphine Sulfate Carpujects 4 mg/mL are packaged in Slim-Pak® tamper detection packages with each box containing 10 Carpujects (NDC 0409-1258-30).

The affected lot was distributed in January 2012. It was initially distributed to wholesalers and a limited number of hospitals in Arizona, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Ohio, Texas and Virginia.

Hospira has not received any reports of adverse events related to this issue for this lot. This is believed to be an isolated event, and Hospira has initiated an investigation to determine the root cause and preventive actions. Consumers should contact their physician or healthcare provider if they have experianced any problems that may be related to taking or using this product.

Anyone with an existing inventory of affected product should stop use and distribution and quarantine the product immediately and call Stericycle at 1-888-912-7088 to arrange for the return of the product. Replacement product from other lots is available.  Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.

Pain Drug Patches Can be Deadly to Children, FDA Warns

FDA evaluated a series of 26 cases of pediatric accidental exposures to fentanyl patches reported over the past 15 years. Of these 26 cases, ten resulted in death and 12 in hospitalization. Sixteen of the 26 cases occurred in children two years old or younger.

Young children are at particular risk of accidental exposure to fentanyl patches. Their mobility and curiosity provide opportunities for them to find lost patches, take improperly discarded patches from the trash, or find improperly stored patches, all of which may result in patches being placed in their mouths or sticking to their skin.

Avastin Fails to Help Older Lung-Cancer Patients in Study

Avastin failed to significantly extend the lives of older lung-cancer patients in a government-funded study, raising questions about whether the treatment should be given to U.S. Medicare enrollees. Patients aged 65 and older who received Avastin in addition to a standard chemotherapy regimen had a median overall survival of 9.7 months, according to the study to be published tomorrow in the Journal of the American Medical Association.

Context A previous randomized trial demonstrated that adding bevacizumab to carboplatin and paclitaxel improved survival in advanced non–small cell lung cancer (NSCLC). However, longer survival was not observed in the subgroup of patients aged 65 years or older. 

Objective To examine whether adding bevacizumab to carboplatin and paclitaxel chemotherapy is associated with improved survival in older patients with NSCLC. 

Design, Setting, and Participants Retrospective cohort study of 4168 Medicare beneficiaries aged 65 years or older with stage IIIB or stage IV non−squamous cell NSCLC diagnosed in 2002-2007 in a Surveillance, Epidemiology, and End Results (SEER) region. Patients were categorized into 3 cohorts based on diagnosis year and type of initial chemotherapy administered within 4 months of diagnosis: (1) diagnosis in 2006-2007 and bevacizumab-carboplatin-paclitaxel therapy; (2) diagnosis in 2006-2007 and carboplatin-paclitaxel therapy; or (3) diagnosis in 2002-2005 and carboplatin-paclitaxel therapy. The associations between carboplatin-paclitaxel with vs without bevacizumab and overall survival were compared using Cox proportional hazards models and propensity score analyses including information about patient characteristics recorded in SEER-Medicare. 

Main Outcome Measure Overall survival measured from the first date of chemotherapy treatment until death or the censoring date of December 31, 2009. 

Results The median survival estimates were 9.7 (interquartile range [IQR], 4.4-18.6) months for bevacizumab-carboplatin-paclitaxel, 8.9 (IQR, 3.5-19.3) months for carboplatin-paclitaxel in 2006-2007, and 8.0 (IQR, 3.7-17.2) months for carboplatin-paclitaxel in 2002-2005. One-year survival probabilities were 39.6% (95% CI, 34.6%-45.4%) for bevacizumab-carboplatin-paclitaxel vs 40.1% (95% CI, 37.4%-43.0%) for carboplatin-paclitaxel in 2006-2007 and 35.6% (95% CI, 33.8%-37.5%) for carboplatin-paclitaxel in 2002-2005. Neither multivariable nor propensity score–adjusted Cox models demonstrated a survival advantage for bevacizumab-carboplatin-paclitaxel compared with carboplatin-paclitaxel cohorts. In propensity score–stratified models, the hazard ratio for overall survival for bevacizumab-carboplatin-paclitaxel compared with carboplatin-paclitaxel in 2006-2007 was 1.01 (95% CI, 0.89-1.16; P = .85) and compared with carboplatin-paclitaxel in 2002-2005 was 0.93 (95% CI, 0.83-1.06; P = .28). The propensity score–weighted model and propensity score–matching model similarly failed to demonstrate a statistically significant superiority for bevacizumab-carboplatin-paclitaxel. Subgroup and sensitivity analyses for key variables did not change these findings.

May, 2012: Retinopathy of Prematurity and Treatment

From the National Eye Institute:

Strategy Confirmed to Help Doctors Determine When to Treat Retinopathy of Prematurity

Surgery or Careful Monitoring of Infants Depends on Disease Characteristics



Scientists have shown that through an eye exam, doctors can identify infants who are most likely to benefit from early treatment for a potentially blinding eye condition called retinopathy of prematurity (ROP), resulting in better vision for many children.
These long-term results of the Early Treatment for Retinopathy of Prematurity (ETROP) study confirm that the visual benefit of early treatment for selected infants continues through 6 years of age. The research, published April 12 online in Archives of Ophthalmology, was supported by the National Eye Institute (NEI), part of the National Institutes of Health.
"This study has set the standard of care for infants with ROP by showing that early treatment of selected high-risk premature babies has positive longer-term results on vision," said NEI Director Paul A. Sieving, M.D., Ph.D.
An estimated 15,000 premature infants born each year in the United States are affected by some degree of ROP. At-risk infants generally are born before 31 weeks of the mother's pregnancy and weigh 2.75 pounds or less.
This disease, which usually develops in both eyes, is one of the most common causes of vision loss in children. About 90 percent of infants with ROP have a mild form that does not require treatment, but those who have a more severe form can develop lifelong visual impairment, and possibly blindness.
During pregnancy, the blood vessels of the eye gradually grow to supply oxygen and essential nutrients to the light-sensitive retina. If a baby is born prematurely, growth of the blood vessels may stop before they reach the edge of the retina. In these newborns, abnormal, fragile blood vessels and retinal tissue may develop at the edges of the normal tissue. The abnormal vessels can bleed, resulting in scars that pull on the retina. The main cause of visual impairment and blindness in ROP is retinal detachment. Laser therapy or cryotherapy, using freezing temperatures, are the most effective treatments to slow or stop the growth of abnormal blood vessels.
"The long-term study has given clinicians evidence that infants with ROP should be treated with different strategies based on an infant's risk for a severe form of the disease, which can be determined through an exam at the bedside," said study chair William V. Good, M.D., of Smith-Kettlewell Eye Research Institute in San Francisco.
Previously, doctors treated infants with ROP when they estimated their risk for retinal detachment to be 50 percent, a strategy developed through the NEI-supported Cryotherapy for Retinopathy of Prematurity study. Although this was a major finding, many infants still went on to develop severe eye disease. Therefore, the first phase of the ETROP study aimed to discover if doctors could identify infants at a higher risk for progression of the disease and intervene early to improve their vision.
In 2003, the ETROP study found that early treatment-upon diagnosis as higher risk for severe ROP-improved the vision and retinal health of certain infants after nine months. These infants had dilated or twisted blood vessels in the retina and substantial growth of new blood vessels, classified as Type 1 disease. Eyes with Type 2 ROP, or a more moderate amount of new blood vessel growth, did not benefit from early treatment. Doctors could predict which infants were more likely to benefit from early treatment by identifying certain eye characteristics, such as the appearance and location of the blood vessels.
The current study followed the same 370 children through 6 years of age, when researchers checked their vision and examined the development of their eyes. The nine-month study recommendations were confirmed through 6 years. Type 1 eyes benefitted from early treatment, and Type 2 eyes had similar results with either early treatment or treatment at the standard time. Seventy-five percent of the early-treated Type 1 eyes were spared legal blindness, compared with 67 percent of Type 1 eyes that received treatment at the standard time. Of the Type 2 eyes that were carefully monitored for disease progression through the standard protocol, more than half improved without treatment.
"Unfortunately, not all eyes selected for early treatment do well," said Robert J. Hardy, Ph.D., director of the ETROP study coordinating center and professor of biostatistics at the University of Texas School of Public Health in Houston. "Additional research is needed to identify still better methods for the prevention and treatment of severe ROP."
# # #
The National Eye Institute (NEI), a component of the National Institutes of Health, is the federal government's lead agency for vision research that leads to sight-saving treatments and plays a key role in reducing visual impairment and blindness. For more information, visit the NEI Web site at
The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit

Thursday, April 19, 2012

Public Citizen: Novo Nordisk injection should be withdrawn due to cancer, pancreas risk

Public Citizen sent a petition to the Food and Drug Administration saying the risks of Victoza far outweigh its benefits as a diabetes drug, a crowded field that includes nearly a dozen similar medications.

The group notes that FDA approved the drug in 2010 against the recommendation of three staff scientists.

“The need for new therapies for Type 2 diabetes is not so urgent that one must tolerate a significant degree of uncertainty regarding serious risk concerns,” wrote reviewer Dr. Karen Mahoney, in an agency memo obtained by Public Citizen.

Wednesday, April 18, 2012

Muscle Milk Class Action Suit Needs Some Beefing Up Says Court

Claire Delacruz, has accused Cytosport of false advertising and misrepresenting the nutritional effects of its Muscle Milk. Specifically, Delacruz alleged that Cytosport used false and misleading terms such as "healthy fats" and "good carbohydrates" on its drink containers, and that its Muscle Milk bars were actually unhealthy and contained as many calories as a chocolate glazed Krispy Kreme doughnut. In addition to state consumer protection and false advertising laws, Delacruz also brought common law fraud and unjust enrichment claims.
Federal district court judge Claudia Wilken found the complaint light on some facts. "[T]he term ‘healthy’ is difficult to define and Plaintiff has not alleged that the drink contains unhealthy amounts of fat, saturated fat or calories from fat, compared to its protein content, based on any objective criteria," wrote Wilken. She also found that many of the claims on the packaging–such as "go from cover it up to take it off" and "from frumpy to fabulous"–was mere puffery.
Wilken, however, held that Muscle Milk’s claims to be a "nutritious snack" and to contain "healthy fats" were actionable, and refused to dismiss the causes of action relating to those phrases, which were printed on the bottle for Cytosport’s 14-ounce Muscle Milk drink. "This representation is more specific than simply that the product is healthy," Wilken wrote. To the extent that Delacruz relied on those phrases and bought Muscle Milk, Wilken allowed her state and common law claims to proceed.
Here's a copy of the opinion: 
"Plaintiff alleges that Defendant has concealed material facts about its products, but does not specify what has been concealed and why it is material.  In sum, the sole cognizable misrepresentation that Plaintiff has plead is the “healthy fats” statement on the fourteen ounce Muscle Milk® RTD container, buttressed by the “nutritious snack” statement.  "
So, Plaintiff's Complaint is dismissed, and she has a week to amend. 

Ingredient in herbal medicines linked to urothelial cancer

A number of researchers have looked at at an herbal ingredient called aristolochic acid, or AA. It comes from plants, including wild ginger (Asarum canadense), that have been used in Chinese medicine to treat “stomach ailments, to restore a woman’s energy after the birth of a child, to treat cough, allergy and breathing problems, and in some weight-loss formula. 

Aristolochic acids are a family of carcinogenicmutagenic, and nephrotoxic compounds commonly found in the Aristolochiaceae family of plants, including Aristolochia and Asarum, which are commonly used in Chinese herbal medicine. Aristolochic acid I is the most abundant of the aristolochic acids and is found in almost all Aristolochia species. Aristolochic acids may be a causative agent in Balkan nephropathy.

On May 31, 2000, the FDA issued a letter to health care professionals concerning the nephrotoxicity and carcinogenicity of botanical products containing aristolochic acid. During this time period, FDA also issued a letter to representatives of the dietary supplement trade associations urging that their members review their manufacturing procedures to ensure that botanical products are free of aristoclochic acid. In addition, FDA issued an import alert providing for the detention of any botanical ingredients that were either labeled as containing the plant Aristolochia or may be confused with it. These actions were the result of several factors, including:

  • In Belgium, there have been approximately 100 cases of renal disease in patients who had participated in a "slimming regimen" from 1990-1992 consisting, in part, of a weight-reducing pill containing powdered herbs. The major pathological lesion consisted of extensive renal interstitial fibrosis with atrophy and loss of tubules. At least 70 of these patients have required either dialysis or transplantation. It was concluded that one of the botanicals (Stephania tetrandra) had been inadvertently substituted with Aristolochia fangchi, a botanical known to contain aristolochic acid, because of the close similarity of the Chinese names.
  • In 1996, it was reported that aristolochic acid-related DNA adducts had been detected in renal tissue from 5 of the original Belgian patients. (Schmeiser HH et al. Detection of DNA adducts formed by aristolochic acid in renal tissue from patients with Chinese herbs nephropathy. Cancer Res 1996;56:2025-8)
  • In August 1999, 2 new cases of interstitial fibrosis were reported from the UK in which the patients had consumed botanical preparations containing aristolochic acid. Both patients have developed end-stage renal failure; one has already been transplanted and the other is awaiting transplant. (Lord GM et al. Nephropathy caused by Chinese herbs in the UK. Lancet 1999;354:481-2)
Since this time, the following new information is available:

  • A study conducted in Belgium reported that among 39 patients with end-stage renal failure from the original Belgian cohort, who had agreed to undergo prophylactic surgery, there were 18 cases (46%) of urothelial carcinoma. All tissue samples analyzed contained aristolochic acid-related DNA adducts. The authors concluded that "our data suggest that aristolochia toxins (aristolochic acids and also possibly other derivatives) cause renal disease and urothelial cancer."[Nortier JL et al. Urothelial carcinoma associated with the use of a Chinese herb (Aristolochia fangchi). N Engl J Med 2000;342:1686-92]
  • Seven cases similar to the Belgian cases were identified in France, corresponding to exposure to botanical preparations contaminated with Aristolochia fangchi from 1989-1992. In May 2000, a case of urothelial carcinoma was diagnosed in one of these patients. A second case of urothelial carcinoma is suspected and in a third patient, lymphoma on a graft was detected. (Communication from the French Medical Products Safety Agency; October 27, 2000)
  • Laboratory analyses by the FDA of certain botanical products sold in the United States have revealed the presence of aristolochic acid. These include single-ingredient products labeled as Aristolochia(sometimes called Virginia snakeroot) and botanicals that are likely to be substituted with Aristolochia (e.g.,Stephania tetrandraClematis armandii, and Akebia extract). In addition, aristolochic acid was detected in several finished products sold as dietary supplements. Warning letters and requests for recalls have been issued to the various manufacturers or distributors involved.
  • Two patients in the U.S. have been recently reported who developed end-stage renal disease in association with the use of botanical preparations containing aristolochic acid.
  • The first patient began using herbal "medicines" in 1994. She progressed to end-stage renal disease within 8 months. A renal biopsy showed extensive interstitial fibrosis with focal lymphocytic infiltration. A renal transplant was performed in 1996. Laboratory analyses of the patient's botanical products, conducted in Belgium, indicated the presence of aristolochic acid in 2 of the products that she had been using. (Meyer MM et al. Chinese herb nephropathy. Baylor Univ Med Center Proc 2000;13:334-7.
  • The second patient had consumed a botanical product called "Stephania tablets" for approximately 2 years, until 1994. She was recently diagnosed with end-stage renal disease and is awaiting a renal transplant. Laboratory analysis by the California Department of Health Services showed the botanical product to contain aristolochic acid. Although the product was labeled as containing the herb Stephania tetrandra, it is likely that Aristolochia fangchi had been substituted for it, thereby accounting for the presence of aristolochic acid in the product. 

Air Rifles Recalled by Air Venturi Due to Ability to Fire With Safety Switch On

The following product safety recall was voluntarily conducted by the firm in cooperation with the CPSC. Consumers should stop using the product immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Evanix Speed and Conquest Air Rifles

Units: About 100

Distributor: Air Venturi of Warrensville Heights, Ohio

Manufacturer: Meca Evanix of South Korea

Hazard: The safety switch can be overcome by pulling the trigger with force, allowing the rifle to fire, resulting in a serious injury or death.

Incidents/Injuries: Air Venturi has not received any reports of the safety switch being overcome.

Description: This recall involves Evanix Speed .177, .22 and .25 caliber rifles and Evanix Conquest .177, .22 and .25 caliber rifles. The rifle is a pre-charged pneumatic air rifle powered by a compressed air cylinder.

Sold at: Air Venturi, Pyramyd Air, Top Airgun and Straight Shooters stores from January 2012 though March 2012 for about $1,800.

Manufactured in: South Korea

Mercury Poisoning Linked to Skin Products

The FDA is warning consumers not to use skin creams, beauty and antiseptic soaps, or lotions that might contain mercury.
The products are marketed as skin lighteners and anti-aging treatments that remove age spots, freckles, blemishes and wrinkles, says Gary Coody, national health fraud coordinator in the Food and Drug Administration’s Office of Regulatory Affairs. Adolescents also may use these products as acne treatments, adds Coody. Products with this toxic metal have been found in at least seven states.
The products are manufactured abroad and sold illegally in the United States—often in shops in Latino, Asian, African or Middle Eastern neighborhoods and online. Consumers may also have bought them in another country and brought them back to the U.S. for personal use.
“If you have a product that matches these descriptions (and others listed below), stop using it immediately,” says Coody.
“Even though these products are promoted as cosmetics, they also may be unapproved new drugs under the law,” says Linda Katz, M.D., director of FDA’s Office of Cosmetics and Colors. FDA does not allow mercury in drugs or in cosmetics, except under very specific conditions, which these products do not meet.
“Sellers and distributors should not market these illegal products and may be subject to enforcement action, which could include seizure of the products and other legal sanctions,” says attorney Brad Pace, J.D., of the Heath Fraud and Consumer Outreach Branch within FDA’s Center for Drug Evaluation and Research.

How to Protect Yourself

  • Check the label of any skin lightening, anti-aging or other skin product you use. If you see the words “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or “mercury,” stop using the product immediately.
  • If there is no label or no ingredients are listed, do not use the product. Federal law requires that ingredients be listed on the label of any cosmetic or drug.
  • Don’t use products labeled in languages other than English unless English labeling is also provided.
  • If you suspect you have been using a product with mercury, stop using it immediately. Thoroughly wash your hands and any other parts of your body that have come in contact with the product. Contact your health care professional or a medical care clinic for advice.
  • If you have questions, call your health care professional or the Poison Center disclaimer icon at 1-800-222-1222; it is open 24 hours a day.
  • Before throwing out a product that may contain mercury, seal it in a plastic bag or leak-proof container. Check with your local environmental, health or solid waste agency for disposal instructions. Some communities have special collections or other options for disposing of household hazardous waste.

Monday, April 16, 2012

New Zealand Bans 3 More Cannabis Products

Down under three cannabis products have been banned under Temporary Class Drug Notices. This has brought the total number of drugs to be banned to 23. The Associate Minister of Health Peter Dunne, said that the three drugs, which have been banned, are AM-1248, AM-2232 and UR-144.

Dunne said that the all the three drugs were being found in products being sold at dairies and some of the products in which these three substances were found were Spice Gold, Spice Diamond and Tai High.

Sushi-linked salmonella outbreak reaches 20 states

Yellowfin tuna has been flagged as the source of a  20-state salmonella outbreak that has sickened 116 people, the U.S. Food and Drug Administration said.

The agency announced Moon Marine USA Corporation of Cupertino, Calif., will voluntarily recall nearly 59,000 pounds of a frozen yellowfin tuna product called "Nakaochi Scrape AA or AAA." The product is tuna "backmeat" scraped from the bones to look like a ground product, and is not sold to customers directly in stores.

FDA adds sexual side effects warning to baldness drug Propecia

Merck's baldness drug Propecia is taken by many American men with thinning hairlines. The drug, known generically as finasteride, is also sold by Merck as a different pill Proscar to treat an enlarged prostate. The U.S. Food and Drug Administration has announced label changes for both drugs, saying they could cause sexual side effects in the men who take them.

Lawyer for murder suspects blames epilepsy drugs

A police rep  said thel was taking the epilepsy drugs Keppra and Lamictal. The source said the suspect had depression and bipolar disorder.

Read more:

Wednesday, April 11, 2012’s Founder Pleads Guilty to Drug Misbranding Charges

On Monday, Ryan Deluca pleaded guilty in federal court in Boise to five misdemeanor counts of introduction and delivery for introduction of misbranded drugs into interstate commerce, said U.S. Attorney Wendy J. Olson. He agreed to pay a $500,000 fine.
Prosecutors said they would not seek prison time. DeLuca’s lawyer said he will stay on as CEO of the company, most of which he sold in 2008.
The plea agreement says that while DeLuca was CEO between 2007 and 2009, the Meridian company sold five products as dietary supplements that the Food and Drug Administration classified as drugs. The supplements contained synthetic anabolic steroids or synthetic chemical clones of anabolic steroids, according to the plea agreement.
Anabolic steroids, technically known as anabolic-androgen steroids (AAS) or colloquially as “steroids” (or even “roids”), are drugs that mimic the effects of testosterone and dihydrotestosterone in the body. They increase protein synthesis within cells, which results in the buildup of cellular tissue (anabolism), especially in muscles. Anabolic steroids also have androgenic and virilizing properties, including the development and maintenance of masculine characteristics such as the growth of the vocal cords, testicles, and body hair (secondary sexual characteristics).
Anabolic steroids were first isolated, identified, and synthesized in the 1930s, and are now used therapeutically in medicine to stimulate bone growth and appetite, induce male puberty, and treat chronic wasting conditions, such as cancer and AIDS. The American College of Sports Medicine acknowledges that AAS, in the presence of adequate diet, can contribute to increases in body weight, often as lean mass increases, and that the gains in muscular strength achieved through high-intensity exercise and proper diet can be additionally increased by the use of AAS in some individuals

The FDA has issued a public health advisory, warning consumers to stop using products that contain these substances. The agency said in 2009 that it had received reports that men between 22 and 55 who had used such products have suffered serious liver injury, stroke, kidney failure and pulmonary embolism.
Read more here:

New Labels for Drospirenone Birth Control

FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

Here is the link:

 The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin.  Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.  See Table 1 for a list of drospirenone-containing products.

Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.
Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.
The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not.  The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots.  For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills.
The revised drug labels (Beyaz, Safyral, Yasmin and Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.  The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.
To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period.
Figure 1 shows the risk of developing a blood clot for women who are not pregnant and do not use birth control pills; for women who use birth control pills; for pregnant women; and for women in the postpartum period.  For example: If 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot.
Figure 1: Likelihood of Developing a Blood Clot
Figure 1 shows the risk of developing a blood clot for women who are not pregnant and do not use birth control pills;  who use birth control pills;  and for women in the postpartum period
COC = combination oral contraceptives or birth control pills
These studies were discussed at the joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. FDA’s briefing document for this meeting is found here.
Previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone were posted on May 31, 2011, September 26, 2011, and October 27, 2011.  The DSC posted in May 2011 updated the public about FDA’s ongoing safety review of two new studies that reported a greater risk of blood clots for women taking drospirenone-containing products as compared to the risk in women taking products containing other progestins.  Previously published studies had reported conflicting findings.  The DSC posted in September 2011 discussed preliminary results from a FDA-funded study suggesting an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing products compared to users of other hormonal contraceptives.  The DSC posted in October 2011 released the final study report and appendices from the FDA-funded study in advance of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting.
Today's communication is in keeping with FDA's commitment to inform the public about the Agency's ongoing safety review of drugs.  FDA will communicate any new information on drospirenone-containing birth control pills and the risk of blood clots when it becomes available.

Table 1. Approved Oral Contraceptives Containing Drospirenone

Brand name
Generic name
BeyazDrospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg
Drospirenone and ethinyl estradiolDrospirenone 3 mg and ethinyl estradiol 0.03 mg
Drospirenone and ethinyl estradiolDrospirenone 3 mg and ethinyl estradiol 0.02 mg
GianviDrospirenone 3 mg and ethinyl estradiol 0.02 mg
LorynaDrospirenone 3 mg and ethinyl estradiol 0.02 mg
OcellaDrospirenone 3 mg and ethinyl estradiol 0.03 mg
SafyralDrospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg
SyedaDrospirenone 3 mg and ethinyl estradiol 0.03 mg
YasminDrospirenone 3 mg and ethinyl estradiol 0.03 mg
YazDrospirenone 3 mg and ethinyl