Wednesday, April 27, 2011

Alli & Xenical: Calls For Pulling the Drugs from the Market

Alli 60 capsule starter packImage by Newbirth35 via Flickr
The group Public Citizen wants the weight-loss drugs Alli and Xenical be removed from the market because of the growing risk of side effects that include liver damage, pancreatitis and kidney stones.

"These drugs have the potential to cause significant damage to multiple critical organs, yet they provide meager benefits in reducing weight loss in obese and overweight patients," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. Find the info here

Pancreatitis is inflammation of the pancreas that can occur in two very different forms. Acute pancreatitis is sudden while chronic pancreatitis "is characterized by recurring or persistent abdominal pain with or without steatorrhea or diabetes mellitus

Hepatotoxicity (from hepatic toxicity) implies chemical-driven liver damage.
The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents, when taken in overdoses and sometimes even when introduced within therapeutic ranges, may injure the organ. Other chemical agents, such as those used in laboratories and industries, natural chemicals (e.g. microcystins) and herbal remedies can also induce hepatotoxicity.

Source for both:  Wiki

FDA to reveiw Trilipix Study

A study of Abbott Laboratories' Trilipix appears to show that women who took the drug in combination with a statin experienced more heart problems than those who just took a statin.

The FDA will meet on May 19th to address the findings of the ACCORD Lipid Study.

Here are the side effects for this drug:

Trilipix Delayed-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Trilipix Delayed-Release Capsules:
Back pain; diarrhea; dizziness; headache; heartburn or indigestion; nausea; sore throat; stomach upset; upper respiratory tract infection.
Seek medical attention right away if any of these SEVERE side effects occur when using Trilipix Delayed-Release Capsules:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf pain, swelling, or tenderness; chest pain; coughing up blood; dark urine; decrease in amount of urine produced; fever, chills, or persistent sore throat; loss of appetite; muscle pain, tenderness, or weakness (especially along with fever or unusual tiredness); pale stools; red, swollen, blistered, or peeling skin; severe or persistent headache, dizziness, or lightheadedness; severe or persistent nausea, stomach pain, or vomiting; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the skin or eyes.

Tuesday, April 19, 2011

Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia

The FDA notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.

Methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.

What the FDA suggests:
  • Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional.
  • Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label. Consumers should store benzocaine products out of reach of children. FDA encourages consumers to talk to their healthcare professional about using benzocaine.

Penumbra Coil 400 by Penumbra Inc.: Class 1 Recall - Premature Detachment of the Co

ISSUE: The Penumbra Coil 400 system includes a tool used to implant the coils inside a patient. The pull wire on the delivery tool can slip out of place and allow premature detachment of the coil. Premature detachment of the coil may cause the coil to unintentionally migrate. This can lead to serious injury including blood clots and stroke.

BACKGROUND: The Penumbra Coil 400 is a small platinum coil placed into a brain aneurysm through the blood vessels leading to the brain. Once the device is in place, the body responds by forming a blood clot around the coil mass, which occludes the aneurysm and helps protect the blood vessel from rupturing or leaking.

RECOMMENDATION: On March 4, 2011, Penumbra, Inc. notified their customers and distributors of the recall and instructed to return the product to the company.


From a recent study:

A damning report on the many shortcomings on the creaky old house that is the FDA. It's a grossly underfunded, undermanned, and mess of an agency. It's decades away from repair, and this report shows that perhaps it's time to dismantle it and start anew: 

Our preliminary findings suggest that shortcomings in FDA’s oversight of the medical device recall process may limit the agency’s ability to ensure that the highest-risk recalls are being implemented in an effective and timely manner. These shortcomings span the entire range of the agency’s oversight activities—from the lack of a broad-based program to systematically assess trends in recalls, to inconsistencies in the way FDA ensures the effective completion of individual recalls.

and this:

Although FDA’s recall data system contains numerous data elements that would allow for analyses of recall data, our preliminary findings suggest that FDA is not using this system to effectively monitor and manage its recall program.

When it came to recalls that were audited:

Our analysis of 2,196 audit check forms associated with the class I recalls we reviewed found a variety of inconsistencies in how the audit checks were implemented and documented for nearly 90 percent of these recalls. For each of these recalls we found inconsistencies in how different investigators determined whether a recall was effective or ineffective when conducting their audit checks of recalls.

To citizens, the FDA is as useful as FEMA was during Katrina. 

Should Xenical be Recalled?

Public Citizen Director Dr. Sidney Wolfe urges patients not to wait for the FDA to remove the drugs from the market and says to stop taking them immediately. "Unlike other drugs, which have a withdrawal syndrome that you would go through if you suddenly stop, there is no downside to stopping Xenical or Alli," says Wolfe.

Both Xenical and Alli are medications that contain the drug orlistat and work to block the body's ability to absorb dietary fat.

The urging from Public Citizen to remove the drugs from the market follows a May 2010 warning issued by the FDA, noting 13 reports of severe liver injury in patients taking orlistat. Public Citizen stated that 73 cases of kidney stones have also been linked to use of the medications.

Find more at public citizen

More information the Topamax Recall

About 57,000 bottles of the prescription anti-seizure drug Topamax are being recalled due to customer complaints of an "uncharacteristic odor," said J and J.
The recall affects two lots of Topamax 100 milligrams tablets shipped and distributed between Oct. 19, 2010 and Dec. 28, 2010 in the United States and Puerto Rico. The tablets were made by Johnson & Johnson's Ortho-McNeil Neurologics division, reported.
There were four consumer complaints about an odor believed to be caused by trace amounts of the chemical TBA (2,4,6 tribromoanisole), which is applied to wooden pallets used to transport and store packaging materials.

On March 4, 2011, the FDA announced new data suggesting that babies born to women who took Topamax during their first trimester have an increased risk of birth defects.
Birth defects associated with Topamax use include but are not limited to:
  • Cleft Lip
  • Cleft Palate
  • Genital Defects
  • Fetal and Skeletal Malformations
A cleft lip or cleft palate occurs when the mouth fails to fully form, causing a split or gap in the roof of the mouth. These deformities may cause developmental issues and can lead to severe ear infections and problems with eating and talking.

Novedex Recall

By now folks have read about the Novedex Recall. 

Possible Side Effects
Potential adverse events associated with the use of anti-aromatases could include:

  • Decreased rate of bone maturation and growth
  • Decreased sperm production
  • Infertility
  • Aggressive behavior
  • Adrenal insufficiency
  • Kidney failure
  • Liver dysfunction
  • Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events
From the FDA site:

Gaspari Nutrition Incorproated, 575 Prospect Street - Suite 230, Lakewood, NJ, announced  that it is conducting a voluntary nationwide recall of all Lot Codes of the company's dietary supplement product sold under the name Novedex XT, which was marketed "for increasing natural testosterone production" and contains 3,17-keto-etiocholetriene, also known as ATD, an anti-aromatase. Gaspari Nutrition is conducting this consumer level recall after being informed by representatives of the Food and Drug Administration (FDA) that 3,17-keto-etiocholetriene does not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Federal Food, Drug, and Cosmetic Act.

Monday, April 18, 2011

Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX®

Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., today announced it is voluntarily recalling two lots of TOPAMAX® (topiramate) 100mg Tablets.  These two lots were shipped between 10/19/2010 and 12/28/2010 and distributed in the U.S. and Puerto Rico.  While the recall encompasses approximately 57,000 bottles of TOPAMAX®, the company believes there are fewer than 6,000 bottles remaining in the marketplace.  The recall stems from four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

Package Description
NDC Code
Lot Number
TOPAMAX® (topiramate) TABLETS 100mg  Bottles of 60 Tablets

TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which products are transported and stored.  In January 2010, we instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to verify that they do not use pallets made from chemically-treated wood.  An internal investigation is underway with our suppliers to evaluate the potential source of this TBA issue.   In addition, we are working with peer companies to better understand how and where TBA is entering and impacting our supply chains and what we can do to further mitigate this exposure.

Source is the J and J site:   Here.

Friday, April 15, 2011

Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine

From the FDA site:

The U.S. Food and Drug Administration (FDA) is informing the public that it continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor (TNF) blockers, as well as with azathioprine, and/or mercaptopurine.
Crohn's disease and ulcerative colitis cause inflammation of the digestive system. Common symptoms are pain in the abdomen, cramps, and diarrhea. Bleeding from the rectum, weight loss, joint pain, skin problems and fever also may occur. Children with the disease may have growth problems, develop intestinal blockage, and experience malnutrition.

FDA believes the risks and benefits of using TNF blockers, azathioprine, and/or mercaptopurine should be carefully weighed when prescribing these drugs to children and young adults, especially for the treatment of Crohn’s disease and ulcerative colitis. Patients should continue to talk to their Healthcare Professionals about the potential risk of HSTCL with use of these medications in order to make the best decision about their medical treatment.

The product labels for Remicade (infliximab) and Humira (adalimumab) have been updated and the product labels for azathioprine and mercaptopurine are being updated to include warnings about HSTCL that have been reported in patients treated with these products

Thursday, April 14, 2011

U-Prosta Recalled

USA Far Ocean Group (Alhambra, CA) voluntarily recalled their product, U-Prosta, a dietary supplement for prostate health .

USA Far Ocean Group is the maker of the product, and it was told by the FDA that laboratory analyses of U-Prosta revealed samples of the product contained terazosin, an active ingredient of an FDA-approved drug to treat Benign Prostatic Hyperplasia (enlarged prostate), making U-Prosta an unapproved drug.

Patients treated for high blood pressure or enlarged prostate who taking U-Prosta could experience some adverse affects, such as hypotension, dizziness or syncope.

 Low blood pressure, or hypotension, occurs when blood pressure during and after each heartbeat is much lower than usual. This means the heart, brain, and other parts of the body do not get enough blood.

Syncope (SIN'ko-pe) is temporary loss of consciousness and posture, described as "fainting" or "passing out.
U-Prosta has been sold and distributed nationwide through retails stores, Internet sales and by mail order. The U-Prosta products involved in this recall are:

U-Prosta Dietary Supplement 60 Capsules 689076499255
U-Prosta Dietary Supplement 30 Capsules 88858100030
U-Prosta Dietary Supplement 1 Capsule No UPC Code

Nutrition Express Voluntarily Recalls Protein Supplements Because Of Possible Health Risk

A company called Nutrition Express  has voluntarily recalled specific products containing whey protein isolate sourced from one supplier because they have the potential to be contaminated with Salmonella
Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. A limited number of products were sold between December 1, 2010 and February 17, 2011.

About 450 bottles of powdered protein were sold at two retail health food stores only (Lindberg Nutrition located in Torrance and Manhattan Beach), both in Los Angeles County, California. Notice of the recall was immediately posted at both stores. The only other sales channel was a direct-to-consumer channel from Nutrition Express, the exclusive distributor of these products.

The products were shipped directly to consumers in the United States via Federal Express or the U.S. Post Office. All consumers, who bought through this direct channel, were immediately sent letters on February 22, 2011 by Nutrition Express regarding the specific recalled product that they purchased.

Source here

Tuesday, April 12, 2011

Alcohol a major cause of cancer?

A wreath Kolsch Beer - LA Times of K├Âlsch.Image via Wikipedia
From Yahoo:

About one in 10 cancers in men and one in 33 in women in western European countries are caused by current and past alcohol consumption, according to a study released on Friday. For some types of cancer, the rates are significantly higher, it said.

In 2008, for men, 44, 25 and 33 percent of upper digestive track, liver and colon cancers respectively were caused by alcohol in six of the countries examined, the study found. The countries were Britain, Italy, Spain, Greece, Germany and Denmark.

April Darvocet Update: JPML Panel Defers Decision Until Late Summer

12/15/2006 - Pillz (DaRvOcEt) #4695a.jpgImage by amayzun via Flickr
From the JPML Order:

On the basis of the papers filed and hearing session held, the Panel has decided to defer its decision on this Section 1407 motion pending further argument at the July 2011 Panel hearing session. Moving and responding plaintiffs and defendants have made persuasive arguments for and against centralization.

Since this Section 1407 motion was filed on December 15, 2010,less than two weeks after the first case commenced, this litigation has grown from four actions involving one defendant to encompass eighteen currently known actions involving more than a dozen different defendants. Consideration of this Section 1407 motion so soon after a handful of actions were filed, where the contours of the litigation are in flux, leaves the Panel with less than ideal information to make the best possible decision. For example, most of the known parties in this litigation, including ten of the thirteen defendants, have not had an opportunity to express their views on the merits of Section 1407 centralization. This is a potentially complex case. Our desire to make the most informed possible decision counsels further deliberation.

With these considerations in mind, the Panel will issue a show cause order setting forth an additional briefing schedule, and further argument for our July 2011 Panel hearing session. While deferring our ruling does delay the Panel’s decision-making process, in the interim, these cases can proceed in the transferor courts. See Panel Rule 2.1(d). In the longer term, this continuation will assure that all parties have an opportunity to be heard, enhance our decision-making process, and should not prejudice the benefits of centralization, if that is our ultimate judgment. 

Find the Order here: 

Monday, April 04, 2011

Stop Using Soladek Vitamin Solution

The U.S. Food and Drug Administration is warning consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D.
Soladek is marketed with claims that the product treats “hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy.” The product is sold in a box labeled in Spanish and containing a vial of the solution.
FDA recently received information that tested samples of Soladek contained levels of vitamin A and vitamin D that were many times the recommended daily allowances for these vitamins.  Intake of excessively high levels of these vitamins poses a risk to human health.
The FDA also received seven reports of serious health problems occurring in consumers using the product. The problems include decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea. Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma.
Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects.
Consumers who are in possession of Soladek should stop using the product immediately. Any consumers who have been using Soladek and are experiencing any of the above symptoms should see a doctor immediately. 
Soladek cannot currently be marketed legally in the United States because U.S. law prohibits the sale of products claiming to treat disease conditions without review and approval by the FDA.  However, the reports of adverse events and other information leads the FDA to conclude that Soladek may be available illegally in the country; therefore, the agency is issuing this warning.

IV Meds Update - Birmingham, AL 4/4/11

Alabama health officials trying identify the source of bacteria suspected in the deaths of nine hospital patients and the sickening of 10 others said last week that the officials found the same bacteria in a pharmacy in Birmingham.

The pharmacy, IV Meds, of Birmingham, had prepared the intravenous feeding solutions that were administered to all of the patients in six hospitals in the state. Bacteria in their blood matched bacteria in a bag of the suspect product found in the pharmacy, he said.


Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)

The FDA rolled out a "Bad Ad" program last week that should make waves in the Pharma industry.

From their site:

FDA's educational outreach program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.

The "Bad Ad" Program is administered by the agency’s Division of Drug Marketing, Advertising, and Communications in the Center for Drug Evaluation and Research. It will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.

Frequently Asked Questions

1. Can I report anonymously?
Yes, anonymous complaints often alert FDA to potential problems.  However, complaints accompanied by names and contact information are helpful in cases for which FDA needs to follow-up for more information.
2. Will DDMAC be able to stop the misleading promotion?          
In many cases, yes, especially if evidence is provided.  Evidence can include the actual promotional materials or documentation of oral statements made by company representatives.
3. What will happen to my complaint once I have contacted DDMAC?          
The information you provide will be sent to the Regulatory Review Officer in DDMAC responsible for this class of drugs.  The reviewer will evaluate it and determine if it may serve as the basis for a potential enforcement action or as valuable information for our ongoing surveillance activities.
4. How do I learn more?
To learn more about DDMAC in-service training for large medical group/hospitals or to speak directly with a DDMAC Reviewer, call 301-796-1200.

Recognize & Report: Contact Information

Division of Drug Marketing, Advertising, and Communications (DDMAC)5
Phone:           877-RX-DDMAC
Write:            FDA/CDER/DDMAC
                    5901-B Ammendale Rd,                                        
                    Beltsville, MD 20705-1266  
Fax:              301-847-8444


Friday, April 01, 2011

Fertility drug link to fatal disease?

Outside the US  there's news of an investigation into the safety of fertility drugs which may show that  the hormones - derived from pregnant or menopausal women's urine - could carry proteins similar to those linked to the fatal Creutzfeldt-Jakob disease.
This is news from the online journal PLoS One, for the first time confirmed the presence of the proteins in the drugs. They were not of the mutated form linked to the human version of mad cow disease, but the findings suggested these too might survive the production process. Source

Creutzfeldt-Jakob disease (CJD) is a rare, degenerative, invariably fatal brain disorder. It affects about one person in every one million people per year worldwide; in the United States there are about 200 cases per year. CJD usually appears in later life and runs a rapid course. Typically, onset of symptoms occurs about age 60, and about 90 percent of individuals die within 1 year. In the early stages of disease, people may have failing memory, behavioral changes, lack of coordination and visual disturbances. As the illness progresses, mental deterioration becomes pronounced and involuntary movements, blindness, weakness of extremities, and coma may occur.
There are three major categories of CJD:
  • In sporadic CJD, the disease appears even though the person has no known risk factors for the disease. This is by far the most common type of CJD and accounts for at least 85 percent of cases.
  • In hereditary CJD, the person has a family history of the disease and/or tests positive for a genetic mutation associated with CJD. About 5 to 10 percent of cases of CJD in the United States are hereditary.
  • In acquired CJD, the disease is transmitted by exposure to brain or nervous system tissue, usually through certain medical procedures. There is no evidence that CJD is contagious through casual contact with a CJD patient. Since CJD was first described in 1920, fewer than 1 percent of cases have been acquired CJD.
CJD belongs to a family of human and animal diseases known as the transmissible spongiform encephalopathies (TSEs). Spongiform refers to the characteristic appearance of infected brains, which become filled with holes until they resemble sponges under a microscope. CJD is the most common of the known human TSEs.