Drug Safety Developments

Group wants heart attack warning on testosterone

Quoted from http://hosted.ap.org/dynamic/stories/U/US_TESTOSTERONE_RISKS_FDA_PETITION 

Group wants heart attack warning on testosterone Feb 25, 2014 By MATTHEW PERRONE AP Health Writer

WASHINGTON (AP) -- A consumer advocacy group is calling on the Food and Drug Administration to add a bold warning label to popular testosterone drugs for men in light of growing evidence that the hormone treatments can increase the risk of heart attack. The group Public Citizen says the agency should immediately add a "black box" warning - the most serious type - to all testosterone medications and require manufacturers to warn physicians about a higher risk of heart attack, stroke and death with the treatments. The FDA announced last month that it was reviewing the safety of drugs like the blockbuster testosterone gel, AndroGel, in light of two recent studies that showed higher rates of cardiovascular problems in men. The agency said its review was first prompted by a U.S. Veterans Affairs study published in November 2013 that showed a 30 percent increase in stroke, heart attack and death among older men taking testosterone. [Article continues at original source]

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Testosterone therapy for low T carries risk: endocrinologists

Quoted from http://www.reuters.com/article/2014/02/20/us-health-testosterone-therapy-idUSBREA1J1CG20140220

Testosterone therapy for "low T" carries risk: endocrinologists

By Kathleen Raven

NEW YORK Thu Feb 20, 2014 10:09am EST

NEW YORK (Reuters Health) - Older men considering taking testosterone for low libido, fatigue, irritability or muscle loss should be made aware of the heart-related risks of testosterone therapy, according to a statement from the Endocrine Society.

Drug companies tout testosterone as a near panacea for such conditions. But the U.S. Food and Drug Administration (FDA) has approved testosterone products only for hypogonadism, when the testicles do not produce enough testosterone.

"Testosterone isn't approved for age-related conditions and age-related decline in testosterone levels," said statement co-author Dr. Shalender Bhasin of Harvard Medical School in Boston.

[Article continues at original source]

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Boehringer facing more than 2,000 U.S. lawsuits over blood thinner

Quoted from http://www.reuters.com/article/2014/02/13/us-boehringer-pradaxa-idUSBREA1C0PW20140213

 

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Boehringer facing more than 2,000 U.S. lawsuits over blood thinner

FRANKFURT Thu Feb 13, 2014 7:03am EST

FRANKFURT (Reuters) - German drugmaker Boehringer Ingelheim said on Thursday it is facing more than 2,000 lawsuits in the United States over claims its blockbuster drug Pradaxa, the first in a new class of stroke prevention pills, caused severe and fatal bleeding.

The unlisted company confirmed the number of cases reported on Thursday by German newspaper Handelsblatt, adding the risk of side effects was known and had to be weighed against the drug's life saving potential.

[Article continues at original source]

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Merck to pay $100 million in NuvaRing contraceptive settlement

Quoted from http://www.reuters.com/article/2014/02/07/us-merck-nuvaring-idUSBREA1615F20140207

Merck to pay $100 million in NuvaRing contraceptive settlement

Fri Feb 7, 2014 11:53am EST

(Reuters) - Merck & Co said on Friday it will pay $100 million to resolve all U.S. product liability lawsuits alleging it downplayed serious health risks involving its NuvaRing intrauterine contraceptive device.

The product, which contains the hormones estrogen and progestin commonly found in birth control bills, is associated with an increased risk of developing blood clots that can cause heart attacks, strokes or sudden deaths. Available to women in the United States since 2001, NuvaRing is one of several contraceptive products linked to this higher risk.

Merck, the second-biggest U.S. drugmaker, denied any fault under the agreement, which must be accepted by 95 percent of about 3,800 eligible patients involved in lawsuits pending in federal and state courts.

[Article continues at original source]

Study of Drug for Blood Clots Caused a Stir, Records Show

Quoted from http://www.nytimes.com/2014/02/06/business/study-of-blood-clot-drug-pradaxa-unnerved-its-maker-documents-suggest.html

Study of Drug for Blood Clots Caused a Stir, Records Show

By KATIE THOMAS

FEB. 5, 2014

The makers of the blood-thinning drug Pradaxa were so worried that an internal research paper would damage drug sales that some employees not only pressured the author to revise it, but suggested it should be quashed altogether, according to newly unsealed legal documents.

The documents were made public last week by a federal judge in Illinois who is overseeing thousands of lawsuits filed by patients and their families, who say that Pradaxa’s manufacturer, the German company Boehringer Ingelheim, failed to properly warn them about the risks of taking the drug.

Since its approval in 2010, the drug, which can cause fatal bleeding, has brought in more than $2 billion in sales in the United States, according to the research firm IMS Health.

It has been prescribed to 850,000 patients, but has also been linked to more than 1,000 deaths.

[Article continues at original source]

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Blood pressure drug combination increases health risk, Health Canada warns

Quoted from http://www.cbc.ca/news/health/blood-pressure-drug-combination-increases-health-risk-health-canada-warns-1.2523251

Blood pressure drug combination increases health risk, Health Canada warns

Warning for aliskiren, ACE inhibitors and ARBs

CBC News Posted: Feb 04, 2014

Combining certain types of blood pressure medications can be risky, Health Canada is warning doctors and patients.

The regulator said Tuesday that recent studies show any combination of aliskiren, a renin inhibitor, and two other classes of drugs, angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB), can be risky.

"Recent studies have demonstrated that any combination of aliskiren, ACEIs or ARBs increases the risks of hypotension (low blood pressure), hyperkalemia (high levels of potassium in the blood) and kidney problems," Health Canada said in a notice to health professionals and patients.

[Article continues at original source]

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New Concern About Testosterone and Heart Risks

Quoted from http://well.blogs.nytimes.com/2014/01/29/study-adds-to-concern-about-cardiac-risks-for-older-men-taking-testosterone/

 

New Concern About Testosterone and Heart Risks

By ANAHAD O'CONNOR

• New York Times, January 29, 2014

A large new study found that prescription testosterone raised the risk of heart attacks in older men and in middle-aged men with a history of heart disease, prompting some experts on Wednesday to call for more extensive warning labels on the drugs.

The new study is one of several in recent years that have highlighted cardiac problems as a potential side effect of testosterone gels, patches, pellets and injections. The hormone is approved for low testosterone levels and is widely marketed for symptoms of “low T,” including fatigue, low libido and loss of energy. Sales in the last decade have soared.

By itself, the new study, which was not a randomized trial, the gold standard in medical research, “may not tell us very much,” said Dr. Michael Lauer, the director of cardiovascular sciences at the National Heart, Lung and Blood Institute, who was not involved in the study. “But when you put this together with the rest of the medical literature, this tells us that we potentially have a problem.”

[Article continues at original source]

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More Evidence Supporting A Link Between Testosterone Therapy And Higher Risk Of Cardiovascular-Related Events Such As Myocardial Infarctions Or Heart Attacks

Increasingly Popular Testosterone Replacement Therapy Drugs Are Linked To Myocardial Infarctions Or Heart Attacks, Strokes, And Deaths

The Growing Use Of Testosterone Creams, Gels, Injections, And Patches Raises Increased Concerns About Risks Of Cardiac Side Effects