PHARMACY

Script Relief launches improved website

BY Ryan Chavis

NEW YORK — Script Relief launched a new and improved HelpRx website that aims to provide a user-friendly experience and additional resources to people searching for prescription drug discounts, as well as information about medications.

Consumers can use the Rx Search tool on the website to find prescription drug coupouns, which can be printed or sent to a user’s email address or mobile phone. The coupons can be presented at more than 50,000 pharmacies across the nation, which savings reaching up to 75% off the prescription’s retail price, the company said.

“The new site integrates information with access. Our hope is that when searching for prescription coupons, users also will find relevant information about their prescription, condition and alternative drug treatment options,” said Ed McCabe, Script Relief’s new media director.

HelpRx also will provide jargon-free, easy-to-read information about multiple conditions like arthritis and diabetes. The site also features an expanded blog and resource center that includes relevant articles and guides for health and medications.

 

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Endo Health Solutions completes Boca Pharmacal acquisition

BY Michael Johnsen

MALVERN, Penn. — Endo Health Solutions on Monday announced that its Qualitest subsidiary has completed the acquisition of privately-held Boca Pharmacal, a specialty pharmaceutical company, for approximately $225 million in cash.  

Boca Pharmacal is a specialty generics company that focuses on niche areas, commercializing and developing products in categories that include controlled substances, semisolids and solutions.  

Boca Pharmacal’s commercial footprint and R&D pipeline is expected to be a strong complement to Qualitest, the company stated. The transaction will be financed with Endo’s current cash on hand.

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FDA re-examining risk profile of FDA-approved testosterone products

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products, the agency announced Friday. 

"We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy," the agency stated. "We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete."

At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their healthcare professionals. Healthcare professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. 

Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles.

None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek) and injection.

The first publication that prompted FDA to reassess the cardiovascular safety of testosterone therapy was an observational study of older men in the U.S. Veteran Affairs health system published in the Journal of the American Medical Association in November 2013. The men included in this study had low serum testosterone and were undergoing imaging of the blood vessels of the heart, called coronary angiography, to assess for coronary artery disease. Some of the men received testosterone treatment while others did not. On average, the men who entered the study were about 60 years old, and many had underlying cardiovascular disease. This study suggested a 30% increased risk of stroke, heart attack and death in the group that had been prescribed testosterone therapy.

A second observational study reported an increased risk of heart attack in older men, as well as in younger men with pre-existing heart disease, who filled a prescription for testosterone therapy. The study reported a two-fold increase in the risk of heart attack among men aged 65 years and older in the first 90 days following the first prescription. Among younger men less than 65 years old with a pre-existing history of heart disease, the study reported a two- to three-fold increased risk of heart attack in the first 90 days following a first prescription. Younger men without a history of heart disease who filled a prescription for testosterone, however, did not have an increased risk of heart attack.

"We urge healthcare professionals and patients to report side effects involving prescription testosterone products to the FDA MedWatch program, using the information in the ‘Contact FDA’ box at the bottom of the page," the agency stated.

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