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

Sensor-equipped pill raises technological, ethical questions

November 17, 2017
The first drug with a sensor embedded in a pill that alerts doctors when patients have taken their medications was approved by the Food and Drug Administration, raiding issues involving privacy, cost, and whether patients ...

New painkillers reduce overdose risk

November 16, 2017
Scientists on the Florida campus of The Scripps Research Institute (TSRI) have developed new opioid pain relievers that reduce pain on par with morphine but do not slow or stop breathing—the cause of opiate overdose.

Separating side effects could hold key for safer opioids

November 16, 2017
Opioid pain relievers can be extremely effective in relieving pain, but can carry a high risk of addiction and ultimately overdose when breathing is suppressed and stops. Scientists have discovered a way to separate these ...

US regulators approve first digital pill to track patients

November 14, 2017
U.S. regulators have approved the first drug with a sensor that alerts doctors when the medication has been taken, offering a new way of monitoring patients but also raising privacy concerns.

Introduction is different, but top medications for opioid addiction equally effective

November 14, 2017
With opioid addiction officially declared a public health emergency in the U.S., medical intervention to treat the illness is increasingly important in responding to the epidemic. Now, a new study concludes that two of the ...

Drugstore pain pills as effective as opioids in ER patients

November 7, 2017
Emergency rooms are where many patients are first introduced to powerful opioid painkillers, but what if doctors offered over-the-counter pills instead? A new study tested that approach on patients with broken bones and sprains ...

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.