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cardiovascular risks 66 articles

Lipocine conducts dosing study on testosterone pill despite new warnings

Specialty drug maker Lipocine Inc., has launched a dosing validation study based on feedback from the Food and Drug Administration (FDA) regarding the protocol for LPCN 1021, the company’s oral testosterone replacement candidate for men with hypogonadism, a hormone deficiency condition in adult men. Lipocine had sought FDA approval earlier in 2016 but was shot down by regulators who questioned the dosing algorithm. The company responded by submitting a new dosing validation study protocol, which the FDA reviewed and approved. The special protocol assessment and validation study are needed in order to secure FDA approval. Lipocine plans to enroll 100 hypogonadal ... Read More

Judge OKs $468M settlement, $150M fees in long-running Celebrex, Bextra case

A New York federal judge gave final approval to a $468 million settlement and approved more than $150 million in attorneys fees and litigation expenses related to a long-running multidistrict litigation (MDL) accusing drug maker Pfizer of withholding data collected between 1998 and 2004 linking the company’s painkillers Celebrex and Bextra to serious cardiovascular risks. The fee request was the result of a lawsuit that lingered over 12 years, involving more than 100 depositions, 65 million pages of documents, and nearly 300,000 hours of legal work, according to Law360. A consolidated complaint was filed in February 2006, and a second class ... Read More

Antares seeks FDA approval of testosterone shot amid growing litigation involving testosterone side effects

The first trials among thousands accusing drug companies of covering up cardiovascular risks with testosterone therapies begin in 2017, but that isn’t keeping Big Pharma from launching new testosterone products into the market. Antares Pharma Inc., announced it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for QuickShot Testosterone (QST), a drug-device combination product for the delivery of testosterone enanthate using a subcutaneous auto injector. Dozens of testosterone replacement treatments flood the market in various versions including topical gels, creams, nasal sprays, injections and tablets. Antares’ QuickShot auto injector offers a less painful alternative ... Read More

Early clinical trials suggested heart risks with diabetes drug Invokana

In the short time that the type 2 diabetes drug Invokana has been on the market, it has been linked to a number of serious side effects including life threatening ketoacidosis and acute kidney injury. But another deadly side effect may soon be unveiled. Johnson & Johnson’s Janssen Pharmaceuticals is currently conducting five studies investigating the cardiovascular risks associated with of its top-selling drug Invokana. Though no data from the study has been released, red flags have been raised. During clinical trials, 13 patients taking Invokana had a heart attack or stroke, compared to just one on a placebo, during ... Read More

AHA offers heart attack, stroke warning signs following celebrity deaths

The holiday weekend was rocked by the news of singer George Michael’s death from heart failure and actress Carrie Fisher’s death due to a heart attack. The news prompted the American Heart Association to remind consumers about the warning signs of heart attack and stroke and when it is time to seek immediate medical attention. Conditions that increase a person’s risk for heart disease, which can lead to heart attack and stroke, include high blood pressure, high cholesterol, diabetes and pre-diabetes, smoking, being overweight or obese, being physically inactive, having a family history of early heart disease, having a history of ... Read More

Merck gives up on experimental osteoporosis drug due to safety concerns

Merck’s experimental osteoporosis drug odanacatib showed that it was effective at preventing bone fractures, but put users at risk of atrial fibrillation and stroke. As a result, Merck said that the risks of the drug outweighed the benefits and thus they were officially giving up on the development of odanacatib. Atrial fibrillation is a quivering or irregular heartbeat that can lead to blood clots, strokes, heart failure, and other heart-related conditions. Two years ago, Merck announced it was delaying a filing with the Food and Drug Administration (FDA) after Phase III results raised cardiovascular safety concerns. The news was a blow ... Read More

FDA rejects Lipocine’s oral testosterone treatment

The Food and Drug Administration (FDA) has rejected the new drug application for Lipocine, Inc.’s LPCN 1021, poised to be the first testosterone pill on the market, due to dosing discrepancies. The FDA issued a complete response letter (CRL) to Lipocine informing the company that its application could not be approved in its present form. The issues involve deficiencies related to the dosing algorithm for the LPCN 1021 label. Lipocine said it plans to request a meeting with the FDA to determine next steps for approving the oral testosterone therapy. LPCN 2012 is a twice daily oral testosterone replacement therapy for men ... Read More

Experimental testosterone pill raises long-term safety concerns

Drug maker Lipocine Inc., is poised to gain Food and Drug Administration (FDA) approval for the first oral testosterone replacement therapy, LPCN 1021. Other testosterone products on the market come in topical gels, patches nasal sprays, or injections. LPCN 1021, Lipocine claims, would offer another option for men who suffer from low testosterone. Oral versions of testosterone have been difficult to formulate because the liver readily deactivates the oral testosterone. This can damage the liver as well as lower HDL cholesterol, considered the “good” cholesterol. Lipicine’s press release touts studies that said LPCN 1021 was “shown to be safe and efficacious.” ... Read More

Testosterone therapy makers eager to market first oral testosterone treatment

Pharmaceutical companies are working vigorously to test testosterone formulations to become the first oral testosterone treatment on the market already well populated with testosterone patches, creams, gels, implants and injections. But in order to win Food and Drug Administration (FDA) approval, they will have to prove they are safe and effective, and will be used only for the condition for which they are intended to treat. This month, Clarus Therapeutics, Inc., announced that its proprietary oral testosterone replacement product Jatenzo, formerly named Rextoro, was currently being tested in patients under a newly launched Phase 3 clinical trial. The announcement comes two years ... Read More

Testosterone replacement is intriguing but carries serious risks

It is difficult not to be lured by advertisements for testosterone replacement therapies, promising increased sex drive, more muscle mass, and increased energy levels by curing so-called “Low T.” It is even more tempting when reputable sources, like the Mayo Clinic, publish an intriguing review promoting the hormone. But public, beware. Studies have shown that testosterone treatments may not do much to boost libido and may increase the risk of cardiovascular events like heart attacks and strokes But what about that Mayo Clinic article? Consider the source. The review was authored by doctors who worked for the testosterone replacement industry, ... Read More