FDA finds medical device recalls nearly doubled in 10 years

The Wall Street Journal says a report to be released today will spotlight the increasing number of problems.

The Wall Street Journal: Medical Device Recalls Nearly Doubled In A Decade
Recalls of defective medical devices nearly doubled in the decade from 2003 through 2012, according to a Food and Drug Administration report due Friday. The total number of recalls rose to 1,190 in 2012, up from 604 in 2003. There was a sharp increase in recalls where the defective product carried a reasonable probability of death. In 2012, there were 57 of these so-called Class I recalls, up from seven in 2003 (Burton, 3/21).

http://online.wsj.com/news/articles/SB10001424052702304756104579452062734883356

 

Testosterone Lawsuits: Low-T Replacement Drugs Linked to Heart Injuries

A 2014 medical study conducted by a team of leading researchers from UCLA and the U.S. National Cancer Institute found a two-fold increased risk of heart attacks in men 65 and older in the 90 days following the first prescription. That same study also showed adverse risks for men younger than 65 who had pre-existing cardiovascular disease. That group had a two- to three-fold increased risk of a heart attack in the 90 days following the first prescription. –

A November 2013 study, conducted on older men in the U.S. Veterans Affairs health system, many of whom had underlying cardiovascular disease, demonstrated that there is a 30 percent increased risk of stroke, heart attack and death in the group that had been prescribed testosterone therapy drugs. The findings were reported in The Journal of the American Medical Association.

 

The products are:

 

• AndroGel – Manufactured by AbbVie
• AndroDerm – Manufactured by Actavis
• Axiron – Manufactured by Eli Lilly and Company
• Bio-T-Gel – Manufactured by Teva Pharmaceuticals
• Fortesta – Manufactured by Endo Pharmaceuticals
• Striant – Manufactured by Columbia Laboratories
• Testim – Manufactured by Auxilium Pharmaceuticals
• Testopel – Manufactured by Auxilium Pharmaceuticals
• Delatestryl – Manufactured by Indevus Pharmaceuticals
• Depo-Testosterone – Manufactured by Pharmacia & Upjohn Company

Tapping a medical-records database of 55,593 men who received prescriptions for testosterone from 2006 to 2010, the current research compared the subjects to themselves before and after receiving their first testosterone prescription.

And they compared the men who got prescriptions for testosterone to a similar group of men who got a first prescription for an erectile dysfunction medication. Men in both of those two groups tend to be of similar age, have similar health problems, and complain of similar symptoms, and so are comparable. But since erectile dysfunction drugs do not affect hormone balance and work in different ways than do testosterone supplements, the researchers who observed differences in the two groups’ heart attack rates would point to a drug effect, not just a correlation between those taking a drug and a negative outcome.

By both measures, older men on testosterone, and younger ones with established heart disease, were significantly more likely to suffer a heart attack shortly after starting a testosterone prescription.

The authors said that large clinical trials should be conducted to clarify which men might incur risks from testosterone supplementation that outweighed its benefits. Until those are conducted and the results are in, they wrote, physicians counseling men who seek testosterone supplements “might be well advised to include serious cardiovascular events in their discussion with patients of potential risks, particularly for men with existing cardiovascular disease.”

 

Pure Edge Nutrition, LLC Issues Nationwide Recall of Bella Vi Brand Products Due to Undeclared Sibutramine and Phenolphthalein

Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator, Bella Vi Insane Amp’d, and two lots of Bella Vi Amp’d Up to the consumer level. The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses. Sibutramine a previously approved controlled substance, was removed from the US market in October 2010 for safety reasons, Phenophthalein is used medicinally as a laxative and not approved for marketing in the US. Therefore, these products are unapproved new drugs.

Products containing sibutramine and phenophthalein pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. To date, the company has not received any reports of adverse events related to this recall. The recall was initiated after discovering the Sibutramine and Phenophthalein were included as ingredients by the manufacturer.

All affected products are marketed as dietary supplements for weight loss and were packaged and distributed as follows:

Bella Vi Insane Bee Pollen Capsules is packaged in bottles of 60 capsules with lot # 201303 EXP: 14/03/07. Bella Vi Insane was distributed to consumers and distributors nationwide from March 1, 2013 – August 31, 2013.

Bella Vi BTrim Max is packaged in bottles of 60 capsules with lot # BTX13 EXP: 2015/08/15. Bella Vi Btrim Max was distributed to consumers and distributors nationwide from August 31, 2013 – September 31, 2013.

Bella Vi BTrim Ultimate Boost is packaged in bottles of 30 capsules with lot # BTRM3452 EXP: 2015/07/03. Bella Vi Btrim was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.

Bella Vi Extreme Accelerator is packaged in bottles of 30 capsules with lot # BTRX7654 EXP: 2015/07/08. Bella Vi Extreme was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.

Bella Vi Insane Amp’d is packaged in bottles of 60 capsules with lot # VINA2013 EXP: 2015/06/12. Bella Vi Insane Amp’d was distributed to consumers and distributors nationwide from June 1, 2013 – September 31, 2013.

Bella Vi Amp’d Up is packaged in bottles of 60 capsules with lot # AU2013AB EXP: 2015/05/20 and lot #BVAU813 EXP: 2015/08/12. Bella Vi Amp’d Up was distributed to consumers and distributors nationwide from May 1, 2013 – September 31, 2013.

Pain Free by Nature Recalls Reumofan Plus Tablets Due to Undeclared Drug Ingredients

Pain Free By Nature is recalling “Reumofan Plus” Tablets purchased through their website at http://www.painfreebynature.com, because they contain undeclared active pharmaceutical ingredients: methocarbamol and diclofenac. Use of this product could result in serious and life-threatening injuries.

Reumofan Plus is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions. This product comes in thirty (30) tablet containers and is packaged in a green and gold box. Reumofan Plus was distributed nationwide through internet sales.

The recall was initiated after the US Food and Drug Administration discovered that the product was distributed in packaging that did not reveal the presence of the active pharmaceutical ingredients, making it an unapproved drug.

Pain Free By Nature did not manufacture the product but did distribute to customers nationwide. Distribution has been completely terminated by the company.

Consumers that have Reumofan Plus should be aware that the product may pose a serious health risk. Consumers who are taking these products or who have recently stopped taking Reumofan Plus should immediately consult a health care professional. Consumers who have purchased the thirty (30) tablet containers of Reumofan Plus are urged to return all unopened bottles to; Pain Free By Nature, LLC, Attn: Nilsen, 211 West 11th Street, Harper, KS, 67058. Refunds will be mailed immediately following processing.

Homeopathic remedies recalled

Terra-Medica, Inc. is voluntarily recalling 56 lots of Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug products in liquid, tablet, capsule, ointment, and suppository forms to the consumer level. FDA has determined that these products have the potential to contain penicillin or derivatives of penicillin, which may be produced during the fermentation process.

In patients who are allergic to beta-lactam antibiotics, even at low levels, exposure to penicillin can result in a range of allergic reactions from mild rashes to severe and life-threatening anaphylactic reactions. To date, Terra-Medica has not received any reports of adverse events related to this recall, nor any reports of product tests indicating penicillin content in the products.

The products are used as homeopathic drugs and have a label stating “Distributed by SANUM USA Corp.” The affected products are identified by package size, batch (lot) number and expiry date (ranging from March 2014 – May 2018) in the table accompanying this release. The batch number can be located at the side panel on the label. The affected products were distributed nationwide through health care practitioners, who may have sold the products through websites.

Terra-Medica is notifying its customers by letter and email and is arranging for return of all recalled products. Consumers and distributors that have product which is subject to the recall should stop using the products and return them to the point of purchase.

 

http://www.fda.gov/Safety/Recalls/ucm389832.htm

 

GSK recalls weight-loss drug Alli in U.S. on tampering concerns

Alli is a turquoise pill. The tainted bottles may contain tablets and capsules of different shapes and colors.

– The outer carton may look authentic.
– The bottle may contain a range of tablets and capsules of various shapes and colors.
– The bottle may not have a label.
– The bottle’s tamper evident seal may not be intact, not be made of foil and/or not have the authentic alli wording: “Sealed for your Protection.”
– The lot numbers and expiration dates on the bottle do not match the lot number and expiration date on the outer carton.
– To date, some bottles bearing the following lot numbers and expiration dates on the carton have been reported to GSK by consumers as containing product other than alli.
– Carton Lot 14372, Expiration: 02/28/2016
– Carton Lot 14395, Expiration: 02/28/2016
– Carton Lot 14124, Expiration: 09/30/2015
– Carton Lot 14267, Expiration: 01/31/2016
– Carton Lot 14442, Expiration: 04/30/2016

Group wants FDA to add warning on testosterone products

A non-profit consumer advocacy group petitioned the U.S Food and Drug Administration (FDA) to add black box warnings on product labels of all testosterone-containing drugs that will explain the increased cardiovascular risks.

Over two decades, 27 studies have been performed and 14 of them show salient increases in cardiovascular risk. The FDA is not convinced that the approved products carry that risk. Dr. Sidney Wolfe, founder and senior adviser of Public citizen’s Health Research Group is outraged by the lack of support from the FDA.

https://www.sycamoreeducation.com/index.php?schoolid=2266

 

 

 

Pfizer recalls antidepressant after report of wrong drug in bottle

Effexor XR antidepressant and another lot of its generic version of the drug after a pharmacist reported finding one capsule of a different medicine in a bottle of Effexor.

“Although Pfizer has not received any other such reports, these three lots are being voluntarily recalled as a precaution because they were packaged on the same line,” the largest U.S. drugmaker said in an announcement of the recall.

 

http://finance.yahoo.com/news/pfizer-recalls-antidepressant-report-wrong-230838090.html

Low Testosterone Medications and Gels – Increased Risk of Non-fatal Myocardial Infarction? – See more at: http://triallawyercenter.com/2014/02/12/low-testosterone-medications-and-gels-increased-risk-of-non-fatal-myocardial-infarction/#sthash.9uhd8hie.dpuf

My office is investigating these products, so call me if you have questions: Mark Zamora, 404 373 1800

In the fetal and embryonic stages of development, testosterone promotes the development of the penis and scrotum and the formation of the structures involved in sperm production. In the pubescent years (age 9 to 14), testosterone helps in the growth of the testes, body hair, muscles and bones as well as sexual maturation and deepening of the voice. In adulthood, testosterone may play a part in sexual function, libido, loss of scalp hair, as well as accumulation of abdominal fat. Between 9 and 14 years of age, the levels of testosterone rise sharply during puberty, which is characterized by enlargement of the testes, pubic and other body hair, muscle and bone growth, deepening of the voice and often acne. If these occurrences are not evident, doctors suggest a number of tests to determine if the male has a condition called hypogonadism.

As men age, their testosterone levels may slowly decline. This occurrence has been called “viripause”, “andropause” or “male menopause.”

This menopause may be caused by the testosterone receptors becoming less receptive, while the amount of free testosterone in the body decreases. The decrease is due to an increase in a blood protein that binds with the hormone, rendering it useless.

The gradual fall in the testosterone levels (from 30 to 40 percent) is common in men between the ages of 48 and 70. As testosterone levels drop, men may experience a loss in muscle strength and function, increase in body fat, decrease in body density and a decrease in sexual function and drive. Of course, your physician first needs to rule out other medical causes for those changes.

 

 

From a study release in January, 2014, there is this discussion point: In older men, and in younger men with pre-existing diagnosed heart disease, the risk of MI following initiation of TT prescription is substantially increased.

<http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0085805&gt;

From the study:

We examined risk of MI with TT prescription in all subjects. Since previous studies indicated that cardiovascular events appeared early in treatment, we focused on the 90 day interval following the filling of a first prescription. For those who did not refill their prescription, we also assessed the interval of 91–180 days. To examine potential effect modification by pre-existing disease, we estimated the effect of TT prescription by prior history of a heart disease diagnosis (ICD-9: 404, 414–414.07, 420–429). We also examined the RR for PDE5I and compared the RRs in the TT prescription and PDE5I cohorts.

Also:

Among men aged 65 years and older, we observed a two-fold increase in the risk of MI in the 90 days after filling an initial TT prescription, the risk declined to baseline in the 91 to 180 days after initial TT prescription, among those who did not refill their prescription. Since we censored follow-up at the first refill, and the supply for most prescriptions was 30 to 90 days, it is likely that there was little use of the medication in the 91 to 180 day post-prescription interval when the risk declined.

What are the products?

Testosterone therapy is most often administered as a gel, patch or injection. The following products treat low testosterone:

• Androderm (Actavis) – patch applied to the skin
• AndroGel (AbbVie Inc.) – topical gel applied to the skin
• Axiron (Lilly USA, LLC) – topical cream applied to underarm
• Bio-T-Gel (Teva Pharmaceuticals) – topical gel applied to skin
• Delatestryl (Endo Pharmaceuticals) – injection or solution
• Depo-Testosterone (Unigen Life Sciences) – injection solution
• Fortesta (Endo Pharmaceuticals) – topical gel applied to skin
• Striant (Auxilium Pharmaceuticals) – buccal tablet absorbed through the gums
• Testim (Auxilium Pharmaceuticals) – topical gel applied to skin
• Testopel (Auxilium Pharmaceuticals) – subcutaneous pellet

 

Risks of testosterone therapy

Men undergoing low T therapy with the following signs of health problems had the greatest increased risk of suffering a heart attack or stroke while taking low T treatments.

• plaque buildup
• artery blockage
• high cholesterol
• diabetes
• obesity

One doctor has explained: Testosterone increases the production of red blood cells, which can clump together or coagulate, essentially making blood thicker. That may be especially hazardous in men who have narrowed arteries because of aging and disease.

Talk with us if you think that you have a serious heart condition that you worry may be linked to use of any one of these products

– See more at: http://triallawyercenter.com/2014/02/12/low-testosterone-medications-and-gels-increased-risk-of-non-fatal-myocardial-infarction/#sthash.9uhd8hie.dpuf

Update on Emergency Department Visits Involving Energy Drinks: A Continuing Public Health Concern

Energy drinks are flavored beverages containing high amounts of caffeine and typically other additives, such as vitamins, taurine, herbal supplements, creatine, sugars, and guarana, a plant product containing concentrated caffeine. These drinks are sold in cans and bottles and are readily available in grocery stores, vending machines, convenience stores, and bars and other venues where alcohol is sold. These beverages provide high doses of caffeine that stimulate the central nervous system and cardiovascular system. The total amount of caffeine in a can or bottle of an energy drink varies from about 80 to more than 500 milligrams (mg), compared with about 100 mg in a 5-ounce cup of coffee or 50 mg in a 12-ounce cola.¹ Research suggests that certain additives may compound the stimulant effects of caffeine. Some types of energy drinks may also contain alcohol, producing a hazardous combination; however, this report focuses only on the dangerous effects of energy drinks that do not have alcohol.

Although consumed by a range of age groups, energy drinks were originally marketed to appeal to youths and were reported to have been consumed by 30 to 50 percent of children, adolescents, and young adults.² Marketing suggests benefits such as increased energy and stamina, weight loss, and enhanced physical and mental performance.² More concentrated forms of energy drinks, known as energy shots, have become increasingly popular among a wider range of age groups, including older adults.³ Marketing analysts reported increasing sales of energy shots in 2011 that were expected to continue through 2012.³ The concentrated amount of caffeine and other ingredients in these drinks has come under scrutiny as the Food and Drug Administration disclosed reports of adverse events with mention of the popular energy shot 5-Hour Energy.⁴

Consumption of energy drinks is a rising public health problem because medical and behavioral consequences can result from excessive caffeine intake. A growing body of scientific evidence documents harmful health effects of energy drinks, particularly for children, adolescents, and young adults.² Research has established that, among college students, there are associations between energy drink consumption and problematic behaviors such as marijuana use, sexual risk taking, fighting, smoking, drinking, and prescription drug misuse.^5,6 In one study, bar patrons who consumed alcohol mixed with energy drinks were 3 times more likely to leave a bar highly intoxicated and were 4 times more likely to intend to drive while intoxicated than those who did not consume alcohol mixed with energy drinks.⁶ This latter finding may be because the high levels of caffeine found in energy drinks can mask the symptoms associated with being intoxicated (e.g., feeling lethargic). Individuals, especially young drinkers, may incorrectly believe that consumption of caffeine can “undo” the effects of alcohol intake and make it safe to drive after drinking. Because of the popularity of energy drinks and the burgeoning literature suggesting the risks involved with their use, gaining additional information about these beverages is important.

The Drug Abuse Warning Network (DAWN) is a public health surveillance system that monitors drug-related emergency department (ED) visits in the United States and can be used as a source of information for assessing the more negative medical consequences associated with consuming energy drinks. To be a DAWN case, the ED visit must involve a drug, either as the direct cause of the visit or as a contributing factor. Such a visit is referred to as a “drug-related visit.” Drugs include alcohol; illegal drugs, such as cocaine, heroin, and marijuana; pharmaceuticals (e.g., over-the-counter medicines and prescription medications); and nutraceuticals, such as nutritional supplements, vitamins, and caffeine products. A previous report addressing ED visits involving energy drinks was published using 2009 data⁷; this issue of The DAWN Report highlights trend data for energy drinks from 2007 to 2011, as well as drug combinations found in 2011.

Source: http://www.samhsa.gov/data/2k13/DAWN126/sr126-energy-drinks-use.htm