Tagged Articles

hormone replacement therapy 68 articles

Evamist HRT recalled due to packaging defect

Perrigo is notifying pharmacists that it is recalling one batch of the hormone replacement therapy (HRT) Evamist Transdermal Spray because there may be cracks in the neck of the vial near the crimp that may cause the product to evaporate or leak out, and thus not properly dispense. This defect may cause consumers to miss the therapeutic benefit of the product in relieving of their menopausal symptoms. Perrigo notified the Food and Drug Administration (FDA) of the recall, and asked pharmacists and distributors with affected products to return them to the company. In accordance with FDA guidelines, Perrigo must verify notifications ... Read More

Pfizer recalls one lot of HRT Premarin due to labeling error

Drug company Pfizer is recalling one lot of the hormone replacement therapy medication Premarin, used to treat menopausal symptoms, due to an incorrect expiration date printed on the labels. The affected lot contains 1.25mg tablets, has the Lot # M35953S and the NDC 0046-1104-91. The expiration date as state on the bottle label is 11/17 and the product is supplied in 1,000-count bottles. Pfizer said the risk to patients is considered negligible, though any side effects or adverse events experienced with affected Premarin pills should be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm. Premarin ... Read More

New Jersey business groups urge court to toss Ethicon whistleblower case again

The New Jersey Supreme Court’s Appellate Division last year decided to revive a whistleblower lawsuit against Johnson & Johnson’s Ethicon unit, triggering a backlash from state business groups who argue that the case effectively would allow employees in watchdog positions to file improper whistleblower lawsuits. Law360 reports that the New Jersey Business & Industry Association and the New Jersey Civil Justice Institute filed a brief June 2 urging the high court to overturn the Appellate court’s decision. They are the latest tort-reform minded groups to push back against the decision, saying that it improperly broadens the state’s whistleblower law by ... Read More

Mildly low testosterone levels do not typically require replacement therapy

Testosterone replacement therapy may be recommended to treat men with very low testosterone levels but it is not typically recommended for older men who are otherwise healthy even if their hormone levels are slightly below what is considered normal, according to Dr. Todd Nippoldt, an endocrinologist with Mayo Clinic. A reader posed the question to Medical Edge from Mayo Clinic about whether he should consider testosterone therapy after a blood test revealed his levels of the hormone were slightly below average. “Should I talk to my doctor about getting treatment even if I don’t have symptoms?” Mildly low levels of ... Read More

Does testosterone therapy pose heart risks for women?

You probably wouldn’t know it from the male-targeted advertisements pushing hormone supplements to boost “Low T,” but testosterone therapy can provide similar benefits for women. The question is, does it also carry the same risk of heart attacks, strokes and death in women as it does for men? Testosterone is considered the male hormone, responsible for the maturation of the testis and prostate as well as the development of sexual characteristics such as increased muscle, bone mass and body hair. In general, adult men have about 7-8 times more testosterone pumping through their bodies than adult females. Estrogen, considered the ... Read More

Testosterone treatments can double, triple heart attack risk in men

Men who use testosterone replacement therapies have a “substantial” risk of having a heart attack, says Francisco Lopez-Jimenez, a Mayo Clinic researcher involved in a new study published in the journal PLOS One. The report is one of a series of new studies looking into the long-term effects of testosterone therapy, a treatment that has increased dramatically in popularity in recent years. The study involving 56,000 men found that older men using testosterone supplements were twice as likely to have a heart attack, and younger men with heart disease were nearly three times as likely to have heart problems. “That’s the ... Read More

Testosterone therapy dangerous for men who have undergone coronary angiography

Men who underwent a heart procedure known as  coronary angiography and used testosterone replacement therapy to increase their low testosterone levels were at a 30 percent increased risk of death, heart attack, or stroke, according to a study published in a recent issue of the Journal of the American Medical Association. Testosterone therapy, which includes products such as AndroGel, Testim and Axiron, has increased greatly in the past decade thanks in large part to aggressive marketing campaigns from pharmaceutical companies encouraging men to talk to their doctors about whether they have “Low T.” Low testosterone levels can be blamed for low libido, ... Read More

FDA approves Pfizer’s new hormone treatment for hot flashes, prevention of osteoporosis

The Food and Drug Administration (FDA) has approved Duavee, Pfizer’s new hormone treatment for menopause-related hot flashes in women who have not had a hysterectomy, and to prevent osteoporosis in post-menopausal women. Duavee is the first FDA-approved drug that combines a mixture of estrogens with another compound, bazedoxifene, which acts like estrogen to protect bone density. The FDA rejected bazedoxifene as an osteoporosis treatment in 2009 after numerous delays based on concerns that the drug could increase the risk for strokes and blood clots. Duavee enters a profitable market that already includes Hisamitsu Pharmaceutical Co.’s Brisdelle and Eli Lilly & ... Read More

Court says former Johnson & Johnson executive’s whistleblower complaint can go to trial

A former Ethicon executive who claims he was fired in retaliation for voicing concerns about product safety and efficacy has had his case upheld and remanded for jury trial by a judicial panel in New Jersey Superior Court. Joel Lippman, former vice president of clinical trials for Johnson & Johnson‘s unit Ethicon, claims he was fired in May 2006 for raising concerns about the safety and effectiveness of several medical products, which resulted in delayed product launches, recalls, and other setbacks for the medical products conglomerate. Mr. Lippman alleges Ethicon retaliated against him even though calling out safety and efficacy ... Read More

Another compounding pharmacy recalls all products due to sterility issues

All sterile products made by Beacon Hill Medical Pharmacy d/b/a Rxtra Solutions, a compounding pharmacy in Southfield, Mich., have been recalled because the Food and Drug Administration (FDA) has raised questions about the sterility of the products. Microbial contamination of products that are intended to be sterile can cause serious infections that can be life threatening. To date, there have been no reports made to Beacon Hill of any adverse reactions related to the recall, nor has any evidence of contamination been found in the recalled products or any products previously prepared by the pharmacy. The recall affects more than ... Read More