Opsumit approved for pulmonary arterial hypertension

October 23, 2013

(HealthDay)—Opsumit (macitentan) has been approved by the U.S. Food and Drug Administration to treat adults with pulmonary arterial hypertension, a debilitating disease characterized by high blood pressure in the lung arteries.

Pulmonary hypertension causes the heart to overwork, which can limit exercise, cause shortness of breath and create the need for a lung transplant. Opsumit relaxes the lung arteries, decreasing in the vessels, the FDA said in a news release.

The drug's safety and effectiveness were evaluated in clinical studies involving 742 people. The medication was found effective in "delaying disease progression," the agency said.

The most common side effects included anemia, cold-like symptoms, bronchitis, headache, flu and urinary tract infection.

Opsumit's label includes a boxed warning that the medication could harm a developing fetus, so the drug should not be taken by pregnant women, the FDA said.

The drug is marketed by Actelion Pharmaceuticals US, based in San Francisco.

Explore further: Adempas approved to treat pulmonary hypertension

More information: To learn more about PAH, visit the U.S. National Heart, Lung and Blood Institute.

Related Stories

Adempas approved to treat pulmonary hypertension

October 9, 2013
(HealthDay)—Adempas (riociguat) has been approved by the U.S. Food and Drug Administration to treat two types of pulmonary hypertension, characterized by high blood pressure in the arteries of the lungs.

Macitentan cuts morbidity, death in pulmonary arterial HTN

August 29, 2013
(HealthDay)—For patients with pulmonary arterial hypertension, the new dual endothelin-receptor antagonist macitentan is associated with reductions in morbidity and mortality, according to a study published in the Aug. ...

Pomalyst approved for advanced multiple myeloma

February 9, 2013
(HealthDay)—Pomalyst (pomalidomide) has been approved by the U.S. Food and Drug Administration to treat cases of multiple myeloma that have not responded to other therapies.

New drug approved to treat HIV-1

August 13, 2013
(HealthDay)—Tivicay (dolutegravir) has been approved by the U.S. Food and Drug Administration to treat infection with HIV-1, a strain of the virus that causes AIDS.

Vibativ approved for certain bacterial pneumonia

June 24, 2013
(HealthDay)—The antibiotic Vibativ (telavancin) has been approved by the U.S. Food and Drug Administration to treat pneumonia caused by Staphylococcus aureus bacteria when other treatments aren't suitable.

First non-hormonal remedy approved for menopausal hot flashes

July 1, 2013
(HealthDay)—Brisdelle (paroxetine) has been approved by the U.S. Food and Drug Administration as the first non-hormonal treatment to treat hot flashes associated with menopause.

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.