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Archive for the ‘FDA Warning’ Category

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

In FDA Warning on February 12, 2014 at 9:35 pm

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

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FDA Adds GI Warning to Benicar Label

In FDA Warning on July 6, 2013 at 12:28 am

The FDA ordered the maker of the blood pressure drug olmesartan (Benicar) to add a warning about the risk of an intestinal condition known as sprue-like enteropathy to the drug’s label.

The connection between sprue-like enteropathy and olmesartan was first reported in June 2012 by Mayo Clinic researchers who, from 2008-2010, had seen 22 patients with symptoms suggestive of celiac disease but antibody blood tests that did not support the diagnosis.

Later in October 2012, researchers at the American College of Gastroenterology meeting noted that olmesartan, an angiotensin II receptor blocker, or ARB, had been linked to another 40 such cases of sprue-like enteropathy.

 

http://www.medpagetoday.com/Cardiology/Hypertension/40278

True Nutrition Recalls Whey Protein Products for Undeclared Milk

In FDA Warning on August 28, 2012 at 2:26 pm

True Nutrition is recalling some of its whey protein products because labels do not declare milk as the source of the whey. Milk is one of the major food allergens. Anyone who is allergic to milk and consumes these products may have a severe or life-threatening reaction. You can see all of the product labels at the FDA site.

The products are: Whey Protein Concentrate in 1 pound packages, with Batch/lot number 0120712, and expiration date of 05/2015. Whey Protein Isolate Cold-Filtration in 1 pound packages, with Batch/lot number 0030812 and expiration date 07/2015. Whey Protein Isolate MicroFiltrated in 1 pound packages, with Batch/lot number 0040812 and expiration date 07/2015. Whey Protein Isolate Cross-Flow Microfiltration in 1 pound packages with Batch/lot number 0730712 and expiration date 07/2015. And Hydrolyzed Whey Protein High Grade in 1 pound packages with Batch/lot number 0680512 and expiration date 05/2015.

 

http://foodpoisoningbulletin.com/2012/true-nutrition-recalls-whey-protein-products-for-undeclared-milk/

Nidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators: Class I Recall

In FDA Warning on June 25, 2012 at 8:51 pm

From the FDA site:

Risk of Fire, Loss of Supplemental Oxygen

Capacitor failure may result in a fire hazard and loss of supplemental oxygen. These products may cause serious adverse health consequences, including death.

Affected products include serial numbers from 042-10000 through 102-09335. These oxygen concentrators were manufactured from January 1, 2004 to May 15, 2010.

BACKGROUND: Oxygen concentrators are used to supply supplemental oxygen to patients within a home setting.

RECOMMENDATION: The firm sent its distributors a Field Correction notice May 1, 2012, asking distributors to contact customers and/or patients who brought these products. Consumers should notify your equipment provider if you have an affected product in your home or place of business. According to the firm, patients may continue to use the device while waiting for a replacement for the corrected component.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program

FDA Alert: Recall of Dietary Supplement Reumofan Plus

In FDA Warning on June 4, 2012 at 1:42 am

The FDA issued a warning to consumers against using a a Mexican “natural” dietary supplement promoted for pain relief due to unlabeled and potentially harmful pharmaceutical ingredients.

The warning for Reumofan Plus was issued after the agency received a number of adverse event reports, including incidences of liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression.

After a laboratory analysis, the agency found Reumofan Plus contains the prescription drugs diclofenac sodium and methocarbamol.

Diclofenac sodium is a nonsteroidal anti-inflammatory drug that may cause cardiovascular events such as heart attack and stroke as well as serious gastrointestinal adverse events including bleeding, ulceration, and fatal perforation of the stomach and intestines, the FDA said in a statement.

Methocarbamol is a muscle relaxant that can cause sedation, dizziness, hypotension and can impair mental and physical performance to drive or operate machinery.

he U.S. Food and Drug Administration is warning consumers that Reumofan Plus, marketed as a “natural” dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.

Consumers who are currently taking Reumofan Plus or who have recently stopped taking Reumofan Plus should immediately consult a health care professional. Consumers should not buy or start using the product.

Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.

The FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps, and adrenal suppression (problems with kidney functioning).

An FDA laboratory analysis of Reumofan Plus found that it contains:

  • diclofenac sodium – a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines.
  • methocarbamol – a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.

These ingredients also may interact with other medications and result in serious adverse events.

The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.

According to FDA adverse events reports, consumers reported symptoms suggesting that some lots of Reumofan Plus may contain corticosteroids. At least one report from a health care professional treating a patient with adverse events from using Reumofan Plus, confirmed adrenal suppression. Abrupt discontinuation of corticosteroids after long-term or high dose use can cause fatigue, nausea, low blood pressure, low blood sugar levels, fever, muscle, and joint pain, dizziness, and fainting.

Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids.

Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm306348.htm

“Japan Rapid Weight Loss Diet Pills Green” Contains Hidden Drug Ingredient

In FDA Warning on April 10, 2012 at 1:28 pm

Not a recall but a warning from the FDA worth reading:

 

The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Japan Rapid Weight Loss Diet Pills Green,” a product for weight loss sold on various websites, such as http://www.amazon.com, and distributed by Xiushentang.

FDA laboratory analysis confirmed that “Japan Rapid Weight Loss Diet Pills Green” contains undeclared phenolphthalein.  Phenolphthalein is a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.  The FDA has classified phenolphthalein as “not generally recognized as safe and effective.” Phenolphthalein has also been found to be genotoxic in that it can damage or cause mutations to DNA.

Consumers should stop using these products immediately and throw them away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: