Consumer Organizations Demand New Warnings on Testosterone Therapy

March 3, 2014,



On January 31, 2014 the FDA published a warning on the risks of testosterone therapy1. This warning prompted news organizations to cover stories about these new risks, and now prominent consumer productions agencies are calling for changes to the warning labels of testosterone therapy products2.

Public Citizen is a consumer advocacy organization with more than 300,000 members and supporters nationwide, and on February 25th 2014 they published a letter3 sent to Margaret A. Hamburg, the commissioner of the Food and Drug Administration (FDA). In the letter they request:

(1) immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs presently on the market in the United States;

(2) ask manufacturers to send "Dear Doctor" letters to warn physicians of these serious
adverse effects;

They call for these new warnings in light of the mounting evidence on the high risk factors from testosterone therapy. One study showed a 30% increase in the risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy. Another study reported a 100 percent increase in the rate of heart attacks among men aged 65 years and older in the first 90 days following the first prescription of testosterone.

Most troubling, a 2013 meta-analysis of testosterone studies noted that studies sponsored by pharmaceutical companies failed to find any risk, but those not sponsored by companies selling testosterone therapy noted a 106% increase4.

Millions of Americans received testosterone therapy without being told of the risks of heart attack, stroke, blood clots, and death. Many Americans who suffered injuries while taking testosterone would not have taken the drugs had they received a fair and full warning. These products include:

• Androgel
• Androderm
• Axirom
• Bio-T-Gel
• Delatestryl
• Depo-Testosterone
• Fortesta
• Striant
• Testim
• Testopel


Learn More about Filing a Testosterone Therapy Lawsuit

If you or a love one has been injured while taking testosterone replacement therapy, please contact one of our experienced pharmaceutical attorneys at Levin Simes LLP for a free case review and legal consultation. Contact Levin Simes at toll-free 1 (888) 426-4156, 1 (415) 426-3000, or contact us online by completing the free consultation form.


(1) January 31, 2014 FDA Safety Announcement - FDA Evaluating Risk of Stroke, Heart Attack and Death with FDA-approved Testosterone Products
(2) February 25, 2014 Reuters article by Toni Clarke. Testosterone drugs should warn of cardiac risk, consumer group says. http://www.reuters.com/article/2014/02/25/us-testosterone-heart-risk-idUSBREA1O11A20140225
(3) February 25, 2014 Public Citizen Letter to Margaret Hamburb, Commissioner of the Food and Drug Administration. http://www.citizen.org/documents/2184.pdf
(4) March 3, 2014 Post by Levin Simes LLP. Did Studies Sponsored by Pharmaceutical Companies Hide Risks of Testosterone? http://www.defectivedruglawyersblog.com/2014/03/did-studies-sponsored-by-pharm.html

Did Studies Sponsored by Pharmaceutical Companies Hide Risks of Testosterone?

March 3, 2014,



An article published in November in BioMed Central discovered serious differences between studies funded by pharmaceutical companies selling testosterone therapy drugs, and those that were independent of pharmaceutical companies pushing the drugs. Combined with the FDA warning1 in January on the risks of testosterone therapy, including heart attacks and strokes, this paints a troubling picture on how the testosterone therapy market was promoted and grew to more than 5 million prescriptions per year by 20132.

Xu et al.3 completed a meta-analysis of placebo-controlled randomized trials of testosterone therapy. 27 studies met their eligibility requirements, including 2,994 mainly older men. An analysis of the 27 studies showed a 54% increase in the risk of cardiovascular-related events. This risk factor was independent of baseline testosterone, meaning the risks increased regardless of whether testosterone therapy was given for those with diagnosed low testosterone ("low T"), or those given testosterone with normal levels.

The most disturbing aspect was revealed when the studies were divided into two groups: 1) studies sponsored by pharmaceutical companies who promoted the products, and 2) studies independent from companies selling testosterone therapy products. Among the studies sponsored by pharmaceutical companies, the risk among those taking testosterone was less than those not taking therapy. The exact opposite findings of independent studies showed a more than double the risk (206 percent). Only when the pharmaceutical sponsored studies were combined with those studies not sponsored did the overall risks factor average out to 54 percent.

Millions of Americans took testosterone therapy without being told of the risks of heart attack, stroke, blood clots, and death. Many Americans who suffered injuries while taking testosterone would not have taken the drugs had they received fair and full warning. These products include:


• Androgel
• Androderm
• Axirom
• Bio-T-Gel
• Delatestryl
• Depo-Testosterone
• Fortesta
• Striant
• Testim
• Testopel


Learn More about Filing a Testosterone Therapy Lawsuit

If you or a love one has been injured while taking testosterone replacement therapy, please contact one of our experienced pharmaceutical attorneys at Levin Simes LLP for a free case review and legal consultation. Contact Levin Simes at toll-free 1 (888) 426-4156, 1 (415) 426-3000, or contact us online by completing the free consultation form.


(1) January 31, 2014 FDA Safety Announcement - FDA Evaluating Risk of Stroke, Heart Attack and Death with FDA-approved Testosterone Products
(2) IMS Data on U.S. testosterone prescriptions for gel, patch and oral dosage forms, 2013
(3) Xu, et al. 2013. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials. BMC Medicine 2013, 11:108 http://www.biomedcentral.com/1741-7015/11/108

FDA Urges Consumers to Report Drug and Medical Device Problems via New Mobile Application

May 20, 2013,

Medwatcherapp.jpg
Earlier this year, a group of private companies and institutions released a new mobile application in collaboration with the Food and Drug Administration Center for Devices and Radiologic Health. It is called MedWatcher, and is a mobile app for use on tablets and smartphones to make reporting negative effects of drugs, medical devices, and vaccines faster and easier. This system is meant for use by voluntary reporters, including healthcare professionals, patients, and caregivers. Medical manufacturers and healthcare facilities are required to continue reporting adverse effects of drugs and other treatments through official government systems for reporting.

It is important that consumers report problems with medical devices or side effects that they believe were caused by a device or drug. The FDA states that voluntary reports are "one important way to help identify and better understand the risks associated with these products. Receiving higher quality reports more quickly helps the FDA identify and respond to safety signals and public health emergencies more efficiently and effectively."
Consumers may also elect to receive information through the app, including FDA safety communications, recalls, and other messages relating to medical products which are of interest to the consumer.

For more information about the app, visit the MedWatcher website at: https://medwatcher.org/index.php

Related Reading:

According to FDA reports, Actos Linked to over 1000 Bladder Cancer Diagnoses

November 12, 2012,

According to a recent review of FDA adverse event reports, the FDA has received over 1000 reports from individuals reporting unexplained diagnoses of bladder cancer after Actos use. This comes after several prominent scientific reports linked Actos use to an increased likelihood of developing bladder cancer.

The institute for Safe Medication Practices (ISMP) recently analyzed Actos complaints reported in the first quarter of 2012. As of January 2011, there were already over 1000 reports filed by individuals who were diagnosed with bladder cancer after using Actos. The ISMP reports, "The cancer risks associated with prescription drugs rank among the most elusive of adverse effects to establish. The carcinogenic potential of scores of approved drugs was first demonstrated in pre-approval studies in rats and mice fed high doses for their two-year lifetimes. But seldom is human risk either confirmed or ruled out with clarity. The Type 2 diabetes drug pioglitazone (Actos) has proved to be the exception."Out of the 1000+ adverse event reports filed since 2011, about 70% were reported by consumers and 30% were reported by doctors and health care professionals.

The ISMP noted that the first indication that Actos increased the risk of bladder cancer was observed in rats in 1999. Initially, the FDA also had reservations about the fact that Actos was also linked to several toxicities in vital organs. In response to allegations, Takeda Pharmaceuticals remarked that it was waiting for the results from a 10-year study it has been conducting on Actos and its link to bladder cancer. The study began in 2003 and final results will be available in 2013. However, data up to this point indicates that there is an increased and easily observed link between Actos and bladder cancer.

In response to growing concerns, the FDA has introduced a black box warning on Actos in August 2011 regarding the Actos - bladder cancer link. France responded by conducting its own national study and eventually recalled Actos all together.

While research is pending about the nature of the scientific link between Actos and bladder cancer, lawsuits are also pending alleging that Actos manufacturer, Takeda Pharmaceuticals, failed to adequately warn patients about the adverse events linked to continued used of their products.

Consumers Urged to Avoid Using Actos and Its Generic Equivalent

November 12, 2012,

After over 1000 adverse event reports, several consumer watchdog groups have urged diabetics to avoid using Actos or its generic equivalent. Many have espoused that actos use may not be worth the associated health risks. A group by the name of "Consumer Reports" noted that Actos should only be used as a "last resort" diabetes drug.

Debate regarding Actos side effects and its link to Bladder Cancer and cardiac events such as heart attacks, strokes, and congestive heart failure was renewed after Mylan Pharmaceuticals received clearance to market a generic form of Actos. Metformin, a similar front-line diabetes drug, may be taken as an alternative to Actos when taken along or taken in combination with glipizide or glimepiride. Metformin is also cost effective. A three month supply may cost as little as $10.

Actos or pioglitatizone was originally marketed by Takeda Pharmaceuticals and approved as a standard type 2 diabetes medication in July 1999. Actos functions by increasing the body's sensitivity to insulin, thus making small amounts more effective. Medications such as ActoPlus and Duetact also include Actos' main active ingredient.

After it was discovered that Avandia, a similar diabetes drug, was linked to serious adverse events such as heart attacks and strokes, several concerns were raised about Actos' potential to cause similar problems. In September 2010, the FDA conducted a study and found that Actos not only shared a propensity for increased risk of heart attack and stroke but also elicited an increased incidence of bladder tumors. Researchers found that Actos use increased one's likelihood of developing bladder cancer by as much as 40%.

Soon after the release of the Actos studies, national markets such as France and Germany recalled Actos altogether. In the United States, increased Actos warnings were provided which indicated that Actos use for more than a year may lead to an increase in the risk of bladder cancer. In addition, the medication was also marked with a black box warning regarding an increased risk of congestive heart failure.

There are currently hundreds of pending Actos product liability lawsuits on behalf of clients who were diagnosed with bladder cancer after using Actos. Plaintiffs allege that Takeda Pharmaceuticals failed to provide adequate warnings about the long term side effects of Actos use.

Case Centralization Sought For Stryker Hip Implant Cases

November 6, 2012,

A recent request was filed to centralize all New Jersey State Court Stryker Hip Implant claims in front of one judge for joint discovery and handling. Cases are often centralized to save litigation resources and expedite the overall litigation process. If approved, this request for centralization may be the first step in a potential MDL, multi-district litigation, for Stryker Hip Implant cases which would include not only New Jersey cases but also include cases throughout the nation.

Stryker Hip Implants recently came under fire when numerous FDA complaints and studies indicated that there may be serious problems associated with Rejuvenate and ABG II modular hip stem component parts due to fretting and corrosion. Common complications include pain, discomfort, swelling, infections, and the necessity for revision surgeries.

According to the request for centralization, there are currently at least ten cases pending for individuals seriously injured by Stryker Rejuvenate and ABG II modular hip stem products. It is expected that the number of cases will grow as lawyers begin reviewing their hip implant cases.

The Stryker Rejuvenate Modular Hip System was first marketed in early 2009. While Stryker claimed that their replacement parts would last up to 20 years, Stryker voluntarily recalled its Rejuvenate and ABG II modular systems only 3 years after reports began to surfaces regarding unusually high hip failure rates and high rates of hip revision surgery to remove the components at fault for injury.

The most common allegation raised in the Stryker lawsuits currently in suit is that the Stryker Rejuvenate Modular neck-stem system has inherent manufacturing defects that increase the likelihood of metal debris being released in the body as components rub against each other. The rubbing action or "fretting" often leads to metallosis, painful inflammation, and the gradual loosening of component parts. Fretting may also lead to necrosis of tissues surrounding the hip and the bone deterioration.


Stryker Orthopaedics Voluntarily Recalls its Rejuvenate and ABG II Modular-Neck Stems

July 16, 2012,

On July 10, 2012, Stryker Orthopaedics recalled its Rejuvenate hip system and ABG II modular-neck stems, both of which are popular components of many of its most popular hip implant systems. Both the Rejuvenate and ABG II modular-neck stems may be used with either metal or ceramic hip implants. However, the Stryker components themselves are composed of metal-on-metal conjunctions. Much like the complications linked to other Metal-on-metal implants such as the beleaguered Depuy ASR hip implant, friction between the moving parts in the Stryker components may cause toxic metal debris to gradually accumulate in the blood stream. Common complications include extreme pain, swelling, nausea, permanent tissue damage and metallosis.

The Stryker Rejuvenate hip system and the ABG II modular-neck stems are components that may be categorized as metal-on-metal joint replacement systems. In recent years, metal-on-metal systems have been heavily scrutinized for their high failure rates. The National Joint Registry of England and Wales found that roughly 6.2% of all metal-on-metal hip replacement systems required revision surgery within 5 years, compared to only 1.7% for metal-on-plastic systems and 2.3% for ceramic-on-ceramic systems. Stryker initially marketed its Rejuvenate hip implant system as providing a complication- free 15-year clinical history. However, since the beginning of 2012, the FDA has received over 45 adverse event reports in relation to complications associated with Stryker's Rejuvenate and ABG II modular-neck stems. The side effects most commonly cited in the adverse event reports are fretting, wear or damage between caused by repeated surface friction, and corrosion.

In a recent press release, Stryker focused on the complications associated with potential fretting and corrosion and the potential risks and benefits for systems with the component parts in question. Stuart Simpson, Vice President and General Manager of Hip Reconstruction stated," While modular-neck stems provide surgeons with an option to correct certain aspects of a patient's anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action". Smith goes on to state," Following this action, we will work with the medical community to better understand this matter as we continue to evaluate the data."

Styker has issued a global recall for both component parts and is urging patients with hip implant systems with either of these products to contact their surgeons as soon as possible to confirm that no fretting, corrosion, or other serious complications are present.



Symptoms:

  • Inflammation/Swelling
  • Intense paint at the site of hip replacement
  • Groin or thigh pain
  • Metallosis
  • Spontaneous Dislocation
  • Tissue Mass or Rash
  • Black tissue
  • Bone Deterioration
  • Chromosomal Damage
  • Carcinogenesis (development of cancerous cells)
  • Increased Lymphocytes (Lymphocytosis- results in "sick" symptoms)
  • Necessity for additional surgeries to remove implants, mass tissue buildup, or infected bones.

Your Potential Claim

Based on this information and your state's statute of limitations, it is best to protect your legal rights now if your hip system has failed or fails in the future. If you believe you have a Hip implant system using a Stryker Rejuvenate hip system, an ABG II modular-neck stem, or any other metal-on-metal hip implant system, it is important that you identify which hip systems you had implanted. You may qualify for compensation.
If you would like Levin Simes LLP to investigate your potential claim, please fill out the contact form below or email us at info@levinsimes.com. We look forward to discussing your case with you

Levin Simes is currently investigating claims for women who have been harmed by transvaginal mesh products. If you or a loved one have been harmed by transvaginal mesh products, you may be entitled to compensation. Contact us for a free consultation .

Ethicon/Gynecare Recalls Four Transvaginal Mesh Products, Restricts the Usage of Others

June 14, 2012,

After being sued by over 600 women who claim that their transvaginal mesh products caused serious-life altering injuries, Johnson & Johnson's Ethicon unit has decided to stop selling four of its most popular transvaginal mesh products and restrict the usage of other Gynecare mesh products.

In a letter filed on June 04, 2012 with U.S. District Judge Joseph Goodwin, an Ethicon spokesperson asked the Food and Drug Administration to stop "commercializing" the following devices:

Recalled Devices

  • Gynecare Prolift ® Pelvic Floor System
  • Gynecare Prolfit + M® Total Pelvic Floor Repair System
  • Gynecare Prosima ® Pelvic Floor Repair System
  • Gynecare TVT Secure™ System

Newly Restricted Devices

  • Gynecare Gynemesh ®PS Nonabsorbale Prolene ® Soft Mesh

Ethicon will continue to sell Gynecare Gynemesh but will change the labeling to restrict its use to only abdominal implantations, likely because research indicates that complications are far less common when mesh implants are implanted abdominally.

Ethicon has requested 120 days to discontinue sales of its products and to give customers, hospitals, and surgeons sufficient time to find alternative products for incontinence and pelvic organ prolapse surgeries. An Ethicon spokesperson states, "Ethicon will also discontinue or revise as appropriate, all marketing materials during this time."

The FDA went on record in March and concluded that J&J/Ethicon has been selling its Gynecare Prolift Pelvic Floor System for three years without prior FDA approval. Ethicon began marketing Gynecare Prolfit mesh in March 2005. Ethicon claimed that the product offered an "innovative and effective surgical option. The FDA first learned of the Gynecare Prolift in 2007 and did not formally clear the Prolift until May 2008.

Afterward, the FDA ordered that J&J and other transvaginal mesh manufactures conduct further studies on the potential complications of transvaginal mesh implants after receiving over 1000 adverse event reports from women all over the United States.

Ethicon/Gynecare products have been linked to the following complications:

  • Vaginal mesh erosion (ie. extrusion or protrusion of the mesh out of vaginal tissue)
  • Organ (bowel, bladder, blood vessel) Perforation
  • Nerve Damage
  • Pain, infection, bleeding, and pain during intercourse (dyspareunia)
  • Urinary problems
  • Recurrent prolapse
  • Neuromuscular problems
  • Vaginal scarring/shrinkage caused by mesh contraction
  • Emotional distress
  • Decreased quality of life

Levin Simes is currently investigating claims for women who have been harmed by transvaginal mesh products. If you or a loved one have been harmed by transvaginal mesh products, you may be entitled to compensation. Contact us for a free consultation .


New Study Links Actos Use to a Doubled Risk of Bladder Cancer after Two Years of Usage, Higher Risk for High Dosage Patients

June 14, 2012,



According to a new study published in the British Medicine Journal which compared healthy people with patients diagnosed with bladder cancer, Actos use has been associated with an 83% increased risk of bladder cancer and a 200% increased risk of bladder cancer if Actos is used for more than 2 years. Previous research indicated that Actos increased one's chances of developing bladder cancer by only 40%.The study concluded that rates were highest in clients who took Actos for 2 year or whose cumulative dosage was over 28,000 mg. The study surveyed over 115,000 patients who were treated with various diabetes drugs. The survey took place over a 21 year period between 1988 and 2009.

Read the most Recent Actos Study.

Researchers concluded that use of Actos for more than two years was linked to 88 additional diagnoses of bladder cancer per 100,000 patient years. Patients who took more than 28,000 milligrams of Actos during their treatment had a much higher risk of developing bladder cancer: the number rose to 137 additional diagnoses of bladder cancer per 100,000 patient years.

The researchers noted that physicians, patients, and top regulatory agencies should consider the recent finding when considering prescribing the drug for future uses, "Prescribers who are ultimately responsible for therapeutic choices can legitimately question whether the benefit-risk ratio of pioglitazone (Actos) is still acceptable for their patients with diabetes," stated Dominique Hillaire-Buys and Jean-Luc Faillie from the Department of Medical Pharmacology and Toxicology in Montpellier, France in an editorial accompanying the study.

This study further solidifies a growing body of research that indicates a link between Actos and bladder cancer. It also solidifies claims that Takeda Pharmaceuticals failed to perform safety studies before marketing Actos and putting thousands of diabetic patients at risk for bladder cancer.

Continue Reading... .


Actos Bladder Cancer Lawsuits Consolidated

January 3, 2012,

MDL Consolidation to eliminate duplicative discovery, prevent inconsistent pretrial rulings, and conserve the resources of the parties, their counsel and the judiciary

Actos (pioglitazone) was marketed by Takeda Pharmaceuticals America Inc. and Eli Lilly and Co. in 1999 for the treatment of Type II diabetes. During a study conducted by Kaiser Permanente, it was demonstrated that use of pioglitazone increased the risk of bladder cancer. Shortly after, the French National Health Insurance launched a similar study which resulted in a similar link to bladder cancer. France and Germany pulled pioglitazone-containing medicines from the market in July of 2011.

220px-USJPML_Seal.jpg

On August 31, a petition was filed with the U.S. Judicial Panel on Multidistrict Litigation asking that the federal Actos cancer litigation be consolidated before a judge for coordinated handling during pretrial proceedings. This would help reduce duplicative discovery and avoid conflicting rulings from judges in different districts. The MDL process would also help facilitate an Actos settlement agreement for bladder cancer victims.

The motion was filed by plaintiffs Glen and Nina Weant, who asked the U.S. Judicial Panel on Multidistrict Litigation to consolidate all federal Actos lawsuits in the U.S. District Court for the Southern District of Illinois before Judge G. Patrick Murphy. At the time of filing, there were 11 lawsuits pending in 8 different federal district courts throughout the United States involving individuals who developed bladder cancer after Actos use. All of the lawsuits involve similar allegations that Takeda Pharmaceuticals failed to adequately research their medication or warn about the increased risk of bladder cancer when Actos is used for long periods of time. However, other plaintiffs filed responses suggesting other jurisdictions for the Actos litigation to be centralized, such as the U.S. District Court for the Northern District of Ohio before Judge Dan A. Polster.



On December 29, the U.S. Judicial Panel on Multidistrict Litigation centralized the Actos litigation before U.S. District Judge Rebecca F. Doherty in the Western District of Louisiana claiming that "the allegations in this nationwide litigation do not have a strong connection to any particular district, and related actions are pending in numerous districts across the country" and that "centralization in the Western District of Louisiana permits the Panel to assign the litigation to an experienced judge who sits in a district in which no other multidistrict litigation is pending."

Read the U.S. Judicial Panel on Multidistrict Litigation's Transfer Order here.

FDA Advisory Panel Meeting on Fosamax

September 19, 2011,

FDA Panel Recommends Label Changes to Reduce Risk of Problems from Fosamax

drug_warning2.jpg Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today. The FDA convened the meeting because of emerging safety concerns related to long-term use -- generally considered more than three to five years -- of bisphosphonates. Bisphosphonates include Aclasta, Actonel, Altevia, Boniva, Fosamax, and Reclast. Four million to 5 million Americans fill prescriptions for the drugs every year, according to the FDA. The panel, made up of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee, voted 17 to 6 in favor of recommending additional labeling information about the drugs' long-term safety and effectiveness. The panel left how those warnings should be worded up to the FDA. While the federal drug regulatory agency is not required to follow the advice of their advisory panels, it is usually heavily influenced by the recommendations. New label information would likely warn users about the reduced benefits from Fosamax and other bisphophonates after they have been taken for several years, and the potential risk of serious and debilitating injuries that could result as the medications build up in the body over a number of years. According to documents released in advance of the panel meeting, some FDA staffers strongly believe that a five year time limit should be placed on taking the drugs, indicating that women get the most benefit in treating osteoporosis during the first three years on the medications.

Related Reading:
Label Changes Needed To Reduce Risk of Problems from Fosamax: FDA Panel FDA advisers wary of time limit on bone drugs

Lisinopril Liver Damage

September 19, 2011,


Lisinopril (Prinivil & Zestril) Linked to Various Severe Adverse Effects


lisinopril_box.jpgLisinopril is a drug of the angiotensin-converting enzyme (ACE) inhibitor class that is primarily used in treatment of hypertension, congestive heart failure, and heart attacks and also in preventing renal and retinal complications of diabetes. It was developed by Merck & Co. and is marketed worldwide as Prinivil or Tensopril and by AstraZeneca as Zestril. In the past few years Lisinopril side effects have been linked to liver damage and liver failure which are life-threatening and often fatal.

Adverse Effects:

  • Liver damage & Acute Liver Failure (ALF)
    • Signs of such liver damage include dark urine, fatigue, jaundice, nausea and stomach/abdominal pain.
  • Hyponatremia
    • Chronic hyponatremia is a metabolic condition in which there is not enough sodium (salt) in the body fluids outside the cells. It can lead to such complications as neurological impairments that affect gait and attention and can lead to falls, osteoporosis, and decreased reaction time.
  • Severe Angioedema & Respiratory Distress
    • Angioedema: a swelling, similar to hives, but the swelling is beneath the skin rather than on the surface which can be life-threatening due to severe associated respiratory symptoms.
  • Other side effects, some or all of which are serious and require immediate medical attention, include:
    • Severe Allergic Reaction (Anaphylaxis): A rare but severe allergic reaction can occur that affects the bowel wall and secondarily causes abdominal pain and requires immediate medical attention.
    • Hyperkalemia: higher-than-normal levels of potassium in the blood
    • Chills, signs of infection
    • Dark urine, decreased urination (oliguria)
    • Hoarseness
    • Itching
    • Yellowing of skin or eyes (jaundice)
    • Abdominal pain, bloating, vomiting
    • Chest pain or tightness, dizziness, lightheadedness, fainting (syncope)
    • Dry cough
    • Fever
    • Joint pain
    • Rash
    • Diarrhea, nausea
    • Drowsiness, headache, tiredness
    • Muscle cramps
    • Fainting/blackouts

Related Reading:

Propecia linked to Erectile Dysfunction, Impotence, and Prostate Cancer

September 13, 2011,


Propecia use has been linked to Erectile Dysfunction, General Sexual Dysfunction, Impotence, and Prostate Cancer

propecia.bmp

propecia1.bmp

Origin

Propecia, known in its generic form as Finasteride, is a common treatment for mail pattern hair loss. In some instances, Propecia is also prescribed to curb issues linked to an enlarged prostate. Propecia was originally produced by Merck in 1992 , originally marketed under the name Proscar, for the purposes of treating benign prostate tumors and treating male pattern baldness.

In March 2011, an eye-opening study published by The Journal of Sexual Medicine showed a link between Propecia ingestion and various forms of sexual dysfunction. According to the study, it's estimated that 15 percent of all men who used Propecia suffered some type of sexual dysfunction, even when they stopped taking the medication. In addition, anywhere between 5 to 23 percent of users may become impotent as a result of using Propecia. There were also statistically significant linkages between Propecia use and the development of breast tissue in men, diminished libido, and erectile dysfunction.

Propecia has also been linked to the development of several rare types of cancer in men. In 2009, a study conducted by The Medicines and Healthcare products Regulatory Agency linked the use of Propecia to a markedly high increase in the incidence of male breast cancer. In June 2011, the FDA issued a report linking Propecia to an increased risk of developing high-grade breast cancer. While high grade prostate cancer is rare, it 's much more aggressive than low-grade prostate cancer, which is the most common form of prostate cancer.

Description

Propecia works by attacking "Sex hormone-binding globulin", known as SHBG. Generally, these molecules attach themselves to the testosterone produced in the body and prevent testosterone metabolism. In effect, SHBG blocks natural testosterone from activating and keeps the body in equilibrium. Given the fact that testosterone increases hair growth, Propecia attaches itself to SHBG to allow testosterone molecules to metabolize and work freely, substantially increasing the incidence of active testosterone in the body. As a result, 48% of Propecia users experienced visible hair growth.

By altering the natural balance of testosterone in the male body, the use of Propecia may lead to several unintended consequences. These unintended consequences were most directly noted in the article in the March of The Journal of Sexual Medicine, which chronicled Propecia's linkages to sexual dysfunction, impotence, and breast development.

Symptoms

Sexual Dysfunction:

  • Erectile Dysfunction
  • Impotence
  • Diminished Libido
  • Abnormal Ejaculation
  • Decreased Ejaculatory Volume
  • Testicular Pain

Increased Incidence of Cancer:

  • Prostate Cancer
  • Male Breast Cancer

Other Adverse Effects:
  • Depression
  • Development of Breasts
  • Birth Defects( in children of mothers who handle tablets)

Reference Information

Propecia Impotence Lawsuit Filed by 26 Year Old Man

FDA Calls for Warning Labels on Drugs for Enlarged Prostate

FDA Report: Fosamax Safety and Efficacy

September 9, 2011,

Fosamax Benefits Not Seen After Five Years

Fosamax.jpg The FDA released a report in preparation for an Advisory Panel Meeting scheduled for September 9, 2011 to review and discuss the available data regarding the long-term (greater than 3 - 5 years) use of Fosamax for the treatment and/or prevention of osteoporosis. In light of safety events that appear to potentially be associated with the long-term use of bisphosphonates (Fosamax-type medications), in March 2010 the FDA Division of Reproductive and Urologic Products (DRUP) requested submission of all available controlled clinical trial data supporting long-term use from all bisphosphonate sponsors with products approved for osteoporosis indications. The report includes sections on Efficacy and Safety, including adverse effects such as:

  • Hypocalcemia
  • Gastrointestinal Disorders
  • Musculoskeletal Pain
  • Acute Phase Reaction
  • Inflammatory Eye Disease (such as iritis, uveitis, or scleritis)
  • Atrial Fibrillation
  • Renal Adverse Events
  • Atypical Subtrochanteric and Femoral Diaphyseal Fractures
  • Osteonecrosis of the Jaw
  • Esophageal Cancer

According to the report prepared by FDA officials in advance of the meetings, Fosamax benefits in protecting against osteoporosis and bone density are not seen beyond five years. In order to maximize the benefits and minimize the risks of these adverse effects, the panel recommended that women should only take Fosamax for five years. In regards to safety, the committee concluded:

The safety of long-term bisphosphonate therapy continues to be unclear as study results are conflicting as to whether or not ONJ, atypical femoral fractures or esophageal cancer are associated with use of bisphosphonates for the prevention and treatment of osteoporosis. The epidemiologic evidence concerning ONJ is suggestive of an increased prevalence of ONJ and ONJ-like findings with increased duration of exposure to oral bisphosphonates, with the highest prevalence observed at 4 or more years of use. However these results would need to be confirmed by additional larger studies. Atypical fractures with radiographic features defined by the ASBMR Task Force appear to have a strong association with bisphosphonates but there is no current consensus on the extent to which cumulative use of bisphosphonates increases the risk of this rare type of fracture. Finally, no definitive evidence is available to support an association between esophageal cancer and long-term use of bisphosphonates.
Related Reading:

FDA Report


Rate and Severity of Adverse Events Following Trans Vaginal Mesh Repair Calls Safety into Question

September 1, 2011,


FDA Executive Summary: Surgical Mesh for Treatment of Women
with Pelvic Organ Prolapse and Stress Urinary Incontinence:

A new report reveals that federal health regulators are considering tough new regulations for surgical mesh used to treat pelvic organ prolapse (POP), which has been linked to thousands of serious injuries and complications.

fda-logo.jpg

RECOMMENDATIONS FOR HEALTH CARE PROVIDERS
The FDA encourages health care providers to:

  • Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.
  • Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives.
  • Consider these factors before placing surgical mesh:
    • Surgical mesh is a permanent implant that may make future surgical repair more challenging.
    • A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications.
    • Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient's quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.
    • Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
  • Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.
  • Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used.
  • Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.
  • Continue to follow the recommendations provided in the 2008 PHN.
CONSIDERATION OF REGULATORY CHANGES
The FDA is considering regulatory changes that may improve our understanding of the safety and effectiveness of this device. Considerations include:
  • A change in risk classification of mesh used for transvaginal POP repair from Class II to Class III, which would require manufacturers to submit premarket approval applications, including relevant clinical data for these devices.
  • Clinical studies to address the risks and benefits of mesh used to treat POP and SUI.
  • Expanded post-market monitoring of device performance

ADVISORY MEETING
On September 8-9, 2011, the FDA will convene a meeting of the Obstetrics-Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss the safety and effectiveness of transvaginal placement of mesh for POP and SUI procedures.

Related Readings:
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting