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Short-term NSAID Use May Cause Heart Attack, Stroke, FDA Warns - Renal and ... - Renal and Urology News

July 10, 2015 Short-term NSAID Use May Cause Heart Attack, Stroke, FDA Warns - Renal and ... - Renal and Urology News

The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID, the FDA says. The risks may increase with longer use and higher doses.

(HealthDay News) -- The U.S Food and Drug Administration on Thursday strengthened the warning labels for non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), regarding increased risk of heart attack or stroke.

The agency said it is taking this action based on recent data that show the risk of heart attack or stroke can increase even after using NSAIDs for a short time. "They used to say they might cause risk of heart attack or stroke. Now we are saying they do cause increased risk of heart attack and stroke," FDA spokesman Eric Pahon told NBC News. In particular, people should avoid taking multiple products that contain NSAIDs, according to the revised FDA warning.

The agency will require drug manufacturers to include the updated warning on both prescription and over-the-counter brands of non-aspirin NSAIDs. People with cardiovascular disease or hypertension should consult a doctor before using an NSAID, the FDA said. However, the agency noted that the cardiovascular risk also is present in people without heart health problems. "Everyone may be at risk -- even people without an underlying risk for cardiovascular disease," Judy Racoosin, M.D., M.P.H., deputy director of the FDA's Division of Anesthesia, Analgesia, and Addiction Products, said in a statement.

Current labeling on over-the-counter NSAIDs warns patients to take the lowest dose possible for the least amount of time possible, and to not use them to treat pain for longer than 10 days.

Source

FDA Drug Safety Communication, July 9, 2015

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Will Rockwell Medical, Inc. (NASDAQ:RMTI) Surprise This Quarter? - Investor Newswire

An Earnings surprise occurs when a company reports earnings that differ from what analysts had expected. An earnings surprise in either a positive or negative direction can often result in significant stock price movement immediately after the earnings announcement, but can also have a long-term effect as well.

Most recently for the quarter ending on 2015-03-31, Rockwell Medical, Inc. (NASDAQ:RMTI) posted a surprise factor of 30%. The company reported actual earnings of $-0.07 which was $0.03 away from what analysts were projecting on a consensus basis.

Rockwell Medical, Inc. (NASDAQ:RMTI) is scheduled to next report earnings for the current quarter on 2015-07-30. Analysts are expecting earnings per share of $-0.1. This is based on the 5 sell-side brokerages polled by Zacks Research. Institutional and retail investors alike will be paying close attention to the analyst estimate revisions leading up to the earnings announcement date. Analyst Price Target Wall Street brokerage analysts covering the company are projecting the stock to go to $16.6 on a short term basis. This is the consensus estimate from the 5 sell-side firms included in the Zacks consensus number. The firm seeing the most upside to the stock has a target of 26, while the most conservative price target sees the stock reaching $4. Using Zacks simplified scale, the stock has a mean rating of 2.2. This is the mean calculation of the 2.2 ratings surveyed by Zacks, where 1 represents a Strong Buy and 5 represents a Strong Sell. Three months ago the stock had a 2.2 rating. Rockwell Medical, Inc., formerly Rockwell Medical Technologies, Inc., manufactures hemodialysis concentrate solutions and dialysis kits, and it sells, distributes and delivers these and other ancillary hemodialysis products primarily to hemodialysis providers in the United States, as well as internationally primarily in Asia, Latin America and Europe. Hemodialysis duplicates kidney function in patients with failing kidneys also known as End Stage Renal Disease (ESRD). ESRD is an advanced-stage of chronic kidney disease (CKD) characterized by the irreversible loss of kidney function. Its dialysis solutions (also known as dialysate) are used to maintain life, removing toxins and replacing nutrients in the dialysis patient’s bloodstream. As of December 31, 2011, it was licensed and was developing renal drug therapies. During the year ended December 31, 2011, it acquired an abbreviated new drug application (ANDA) for a generic version of an intravenous Vitamin-D analogue, calcitriol.

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Entresto Approved for Heart Failure - Renal and Urology News - Renal and Urology News

July 10, 2015 Entresto Approved for Heart Failure - Renal and Urology News - Renal and Urology News

Entresto helps reduce the rate of cardiovascular death and hospitalization, compared to the drug enalapril.

(HealthDay News) -- The U.S. Food and Drug Administration on Tuesday approved the drug Entresto (sacubitril/valsartan) to treat heart failure.

Entresto was evaluated in clinical trials involving more than 8,000 adults. It was shown to reduce the rate of cardiovascular death and hospitalization, compared to the drug enalapril. Most clinical trial participants were taking currently approved medications for heart failure, including ?-blockers, diuretics, and mineralocorticoid antagonists.

Common side effects of Entresto included hypotension, hyperkalemia, and renal impairment, according to the agency. A more serious adverse effect was angioedema. Blacks and those with a history of angioedema are at higher risk of this reaction, the FDA said. Entresto should not be used with any angiotensin converting enzyme inhibitor, which would increase a user's risk of angioedema. And women should discontinue Entresto as soon as possible if they become pregnant, the FDA warned.

"Heart failure is a leading cause of death and disability in adults," Norman Stockbridge, M.D., Ph.D., director of the division of cardiovascular and renal products in the FDA's Center for Drug Evaluation and Research, said in a statement. "Treatment can help people with heart failure live longer and enjoy more active lives."

Entresto is produced by Novartis, based in East Hanover, N.J.