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Testosterone Therapies May Be Linked to Increased Cardiac Injuries

Testosterone Therapies May Be Linked to Increased Cardiac Injuries

“A man on TV is selling me a miracle cure that will keep me young forever. It’s called Androgel… for treating something called low T, a pharmaceutical-recognized condition affecting millions of men with low testosterone, previously known as getting older.”

Stephen Colbert (October 3, 2012)

 

FDA Investigation

 On January 31, 2014, the FDA announced an investigation to evaluate the risks of cardiovascular complications associated with FDA-approved testosterone products. According to the FDA, the investigation was issued in response to several studies that show an increased risk of stroke, heart attack and death in men using the therapy.

Pharmaceutical Companies and Testosterone Therapy

In recent years, men have increasingly turned to testosterone therapy in hopes of improving lowered sex drives and energy levels, among other symptoms that are often associated with low testosterone levels. Although some individuals may regard testosterone therapy as the key to male vitality, several studies have linked the therapy to serious side effects and cardiac risks, especially among men who may not have a medical need for the therapy.

According to a 2013 report in the Journal of the American Medical Association, the use of hormones among men over 40 increased by almost 360 percent between 2001 and 2011. Pharmaceutical companies may have played a large role in this increase as they try to grow a market and overpromote their product by turning a life experience, such as aging, into a condition that requires medical diagnoses. Additionally, some pharmaceutical companies may not have specifically addressed heart attack or stroke warnings on the testosterone therapy labels.

Studies Link Testosterone Therapy to Increased Cardiac Injuries

Between 2005 and 2011, researchers with Veterans Affairs conducted a study of approximately 8,700 male Veterans with an average age of 60 who had a history of heart problems, and 1,223 of those participants were given testosterone therapy in various forms, such as injections, gels, or patches. According to the study, which was published in the Journal of the American Medial Association in November 2013, patients undergoing testosterone treatments were 30 percent more likely to suffer from heart attack, stroke, and death when compared to senior males not using the treatments.

Another study published in PLOS One revealed an increased risk of adverse outcomes associated with testosterone therapy in males over the age of 65, in addition to males younger than 65 who have pre-existing heart conditions. Researchers studied the records of more than 55,500 men who were prescribed various forms of testosterone therapy. According to Forbes, researchers found that the risk of heart attacks “doubled during the first three months after starting therapy in men younger than 65 who had a history of heart disease” and “also doubled for all men older than 65—those with or without heart disease.”

Testosterone Therapy and the Need for Medical Tests

Testosterone therapy may provide benefits for male hypogonadism, which is the failure of the body to produce enough testosterone, sperm, or both, and can result in fatigue, decreased sex drive, and difficult concentrating, among other emotional and physical changes. Men’s testosterone levels naturally begin to decline around the age of 30 and may also lead to these effects.

Since the symptoms of hypogonadism are similar to those of the aging process, it is imperative that men are properly tested before proceeding with testosterone therapy to avoid unnecessary risks. The FDA maintains that “[t]estosterone products are FDA- approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.”
 

Altaire Pharmaceuticals Recalls Nine Lots of Eye Drops Due to Concerns About Preservative

Altaire Pharmaceuticals Recalls Nine Lots of Eye Drops Due to Concerns About Preservative

Mold and fungus can be hazardous to the health of consumers, especially if they are found in a product that is meant to be consumed. While mold can be expected to grow on certain perishable foods such as bread and fruit, it might come as a surprise to find mold or detect fungus in pharmaceutical products. In March, Med Prep Consulting Inc. voluntarily recalled a magnesium sulfate IV solution due to the presence of fungus in at least five bags.

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Park Pharmacy & Compounding Center Recalls Two Lots of Sterile Preparations

Park Pharmacy & Compounding Center Recalls Two Lots of Sterile Preparations

The Food & Drug Administration has discovered many issues with drug products that are meant to be sterile this year. The issues have often occurred at compounding pharmacies, which create specialized medical products for patients with unique needs. For instance, Specialty Compounding recently recalled all of its sterile medications due to reports about bacterial infections. Now, another compounding pharmacy is having issues with sterility assurance.

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Jack Rabbit Inc. Recalls One Lot of Dietary Supplements Due to Undeclared Drug Ingredient

Jack Rabbit Inc. Recalls One Lot of Dietary Supplements Due to Undeclared Drug Ingredient

The Food & Drug Administration occasionally discovers an ingredient or bacteria in a drug or product that wasn’t labeled for, or supposed to contain, the ingredient or bacteria. For instance, microbial contamination was recently discovered in sterile medications manufactured by Specialty Compounds, reportedly causing 15 patients to develop severe bacterial infections.

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Sandoz Recalls One Lot of Birth Control Pills Due to Improper Tablet Placement

Sandoz Recalls One Lot of Birth Control Pills Due to Improper Tablet Placement

It is very important for birth control pills to be effective for women. When they aren’t, the prescription medication can be dangerous for its users. In 2010, a lot of controversy arose when news broke that Bayer Healthcare Pharmaceuticals produced birth control pills that carried dangerous side effects, such as potential blood clots. Today, another type of birth control pill is being recalled for a different reason.

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Fresenius Kabi Recalls Four Lots of Benztropine Mesylate Injections

Fresenius Kabi Recalls Four Lots of Benztropine Mesylate Injections

In March, Med Prep Consulting Inc. announced the recall of a magnesium sulfate intravenous solution after traces of fungus were reportedly found in at least five bags of the solution. Although no infections among patients who had received the affected IV were reported, the contaminated solution posed a serious health risk. Early this month, a similar recall involving unwanted particles inside the packaging of a crucial medication was issued.

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Anti-Epileptic Drug Depakote Linked To Birth Defects

Anti-Epileptic Drug Depakote Linked To Birth Defects

Since its first approval in 1983 for seizures, Depakote has been approved to treat various conditions. However, numerous studies conducted over the years have shown that women who take Depakote during pregnancy may have children that suffer from severe birth defects. Unfortunately, the drug’s labels may not have properly informed women of the risks.

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Indianapolis-Based Compounding Pharmacy Issues Multi-State Recall of Nearly 100 Products

Indianapolis-Based Compounding Pharmacy Issues Multi-State Recall of Nearly 100 Products

Earlier this week, Balanced Solutions compounding pharmacy of Lake Mary, Florida announced a voluntary recall of 53 drugs after an FDA inspection found gram-negative bacteria in one of their products. Quality control in compounding pharmacies is crucial to patient safety, as a lack of sterility may put the patient at an increased risk for infection or illness.

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Florida-Based Balanced Solutions Compounding Pharmacy Recalls 53 Products

Florida-Based Balanced Solutions Compounding Pharmacy Recalls 53 Products

Following the distribution of more than 17,000 contaminated steroid injections by the New England Compounding Center of Massachusetts last year, the FDA has emphasized the need for compounding pharmacies to uphold the required safety standards. As part of this emphasis, the FDA has been implementing nationwide inspections to improve sterilization and cleanliness standards in compounding pharmacies. In recent weeks, several compounding pharmacies have

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