FDA Approves First New Tuberculosis Drug In 40 Years

FDA Approves First New Tuberculosis Drug In 40 Years

WASHINGTON — The Food and Drug Administration on Monday approved a Johnson & Johnson tuberculosis drug that is the first new medicine to fight the deadly infection in more than four decades.

The agency approved J&J's pill, Sirturo, for use with older drugs to fight a hard-to-treat strain of tuberculosis that has not responded to other medications. However, the agency cautioned that the drug carries risks of potentially deadly heart problems and should be prescribed carefully by doctors.

Roughly one-third of the world's population is estimated to be infected with the bacteria causing tuberculosis. The disease is rare in the U.S., but kills about 1.4 million people a year worldwide. Of those, about 150,000 succumb to the increasingly common drug-resistant forms of the disease. About 60 percent of all cases are concentrated in China, India, Russia and Eastern Europe.

Sirturo, known chemically as bedaquiline, is the first medicine specifically designed for treating multidrug-resistant tuberculosis. That's a form of the disease that cannot be treated with at least two of the four primary antibiotics used for tuberculosis.

The standard drugs used to fight the disease were developed in the 1950s and 1960s.

"The antibiotics used to treat it have been around for at least 40 years and so the bacterium has become more and more resistant to what we have," said Chrispin Kambili, global medical affairs leader for J&J's Janssen division.

The drug carries a boxed warning indicating that it can interfere with the heart's electrical activity, potentially leading to fatal heart rhythms.

"Sirturo provides much-needed treatment for patients who have don't have other therapeutic options available," said Edward Cox, director of the FDA's antibacterial drugs office. "However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don't have other treatment options."

Nine patients taking Sirturo died in company testing compared with two patients taking a placebo. Five of the deaths in the Sirturo group seemed to be related to tuberculosis, but no explanation was apparent for the remaining four.

Despite the deaths, the FDA approved the drug under its accelerated approval program, which allows the agency to clear innovative drugs based on promising preliminary results.

Last week, the consumer advocacy group Public Citizen criticized that approach, noting the drug's outstanding safety issues.

"The fact that bedaquiline is part of a new class of drug means that an increased level of scrutiny should be required for its approval," the group states. "But the FDA had not yet answered concerns related to unexplained increases in toxicity and death in patients getting the drug."

The FDA said it approved the drug based on two mid-stage studies enrolling 440 patients taking Sirturo. Both studies were designed to measure how long it takes patients to be free of tuberculosis.

Results from the first trial showed most patients taking Sirturo plus older drugs were cured after 83 days, compared with 125 days for those taking a placebo plus older drugs. The second study showed most Sirturo patients were cured after 57 days.

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LOOK: World's Oldest Identical Twins Celebrate 103rd Birthday

LOOK: World's Oldest Identical Twins Celebrate 103rd Birthday

On Monday, the world's oldest living identical twins celebrated their 103 birthday!

Charlotte Eisgrou and Ann Primack of South Florida and Daytona Beach, Fla. are still in the best of health, despite their age. Neither uses a hearing aide or reading glasses, reported the Daily Mail.

"I feel wonderful. I have all my faculties," Eisgrou told the Daytona Beach News-Journal.

Although the pair was unable to spend their birthday together since they are both recovering from recent falls, they still consider each other best friends.

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The twins were born two months premature in Chicago in 1909. They weighed a combined 7 lbs. Since they were born before incubators were invented, they wrapped in blankets and put in the door of a stove to keep warm, reported the Daily Mail.

From then on they remained inseparable.

Eisgrou moved to Florida in 1949, and Primack followed her in 1971. There, they enjoyed the majority of their lives, outlived their husbands, and had one son each.

They're both astonished by their record-breaking age.

"I can't believe it, that I've reached that age. The good thing is our minds are sharp. That's the only good thing," Primack told ABC.

Amazingly, the twins continue to live almost completely independently.

Eisgrou started driving at age 78, and didn't stop until four years ago, when her now 71-year-old son told her "I shouldn't get a new car with all the hijackings," reported the Daytona Beach News-Journal.

They both use a cane to walk, but are healthy and independent. Primack even survived ovarian cancer years ago.

Their longevity may in part be due to their sense of humor. They recalled to the Daytona Journal that they often used to switch husbands when they visited each other.

"I used to visit Daytona and we'd switch husbands and walk in the temple," Primack said, "And they'd say to me, 'Charlotte, you look so good.'"

"Nobody ever knew the difference. And by the time they found out, they were hysterical," Eisgrou told ABC. "We had so much fun."

"They are very funny," Jerry Primack, Ann's son, added. "They bicker constantly."

Although the sisters have always been close, they cannot agree on what has led them to live such a long life.

According to the Daily Mail, Primack credits genes and "never being fat" while her twin Eisgrou says it's because she drank lots of milk.

"Everybody asks me that. I don't know what it was," Primack told ABC. "I didn't watch my food when I was young. I smoked. We all smoked."

Eisgrou added: "I don't know the secret to a long life. And I wouldn't tell you if I knew it."

"We love each other and we always will," Primack told ABC.

Eisgrou and Primack are the second oldest twins in the world, born 39 days after non-identical twins Edith Ritchie and Evelyn Middleton from Aberdeenshire, Scotland.

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Cough Syrup Kills More Than 30

Cough Syrup Kills More Than 30

By ZAHEER BABAR, The Associated Press

LAHORE, Pakistan -- Authorities are investigating cough syrup believed to have killed 33 people in eastern Pakistan in the past three days, a government official said Saturday, the second time in recent months that suspect medicine is thought to have caused multiple deaths.

Also Saturday, an explosion ripped through a passenger bus while it was at a terminal in the southern city of Karachi, killing four people and wounding 40 others, police and hospital officials said. It's unclear if the blast was caused by a bomb or a gas cylinder exploding.

The deaths from the cough syrup occurred in Gujranwala and villages surrounding the city, said Abdul Jabbar Shaheen, the top administrative official in Gujranwala. Another 54 people are being treated at hospitals in the city who are also believed to have consumed the syrup. Those involved are thought to be laborers or drug addicts who drank the syrup to get high, said Shaheen.

Chemical samples collected from the victims' stomachs contained dextromethorphan, a synthetic morphine derivative used in cough syrup that can have mind-altering effects if consumed in large quantities, said Shaheen. It is being investigated whether the people affected by the syrup in Gujranwala drank too much of it, or whether there was a problem with the medicine itself, he said.

Twenty-three people died in the nearby city of Lahore in November after drinking bad cough syrup sold under the brand name Tyno. They were also described at the time as people who consumed the drug to get high.

Shaheen said the cough syrup involved in the incidents in and around Gujranwala was not sold under a single brand. He said there were some people in the city involved in the business of making cough syrup specifically to sell to drug addicts, and officials were trying to arrest the culprits.

Officials temporarily closed one Lahore-based pharmaceutical company whose cough syrup was found in the possession of some of those affected in Gujranwala and were investigating whether it caused any of the deaths, said Shaheen.

The blast that ripped through the bus in Karachi on Saturday set the vehicle on fire and reduced it to little more than a charred skeleton. Police were trying to determine whether the explosion was caused by a bomb or a gas cylinder, said police spokesman Imran Shaukat. Many buses in Pakistan run on natural gas.

The explosion killed at least four people and wounded 40 others, some of whom were in critical condition, said Seemi Jamali, a doctor at the hospital in Karachi where they were being treated.

Karachi has a long history of political, ethnic and sectarian violence. It is also believed to be home to many Taliban militants who have fled U.S. drone attacks and Pakistani army operations in the country's northwest.

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Associated Press writer Adil Jawad contributed to this report from Karachi, Pakistan.

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