newsdailyMay 10, 2019


NEW YORK (Reuters) – US health regulators said a third cancer-causing toxin was found in some blood pressure pills recalled by India’s Hetero Labs Ltd a day earlier, adding to a global recall of commonly used drugs to treat hypertension.

The US Food and Drug Administration is also looking into whether these types of impurities could be found in other classes of drugs, a spokeswoman for the regulator said.

The latest toxin, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), identified in 87 lots of Hetero’s losartan potassium pills, was not found in medicines that were previously recalled by a number of drugmakers.

Most recently, the US unit of Indian generic drugmaker Aurobindo Pharma Ltd expanded the recall of its hypertension medicines containing valsartan to 38 more lots due to the presence of probable carcinogen, N-nitrosodiethylamine (NDEA), the FDA said on Friday.

Global authorities have been clamping down on sales of some blood pressure medicines as they are suspected to be tainted with NDEA and another probable carcinogen N-nitrosodimethylamine (NDMA).

The drugs, including losartan, belong to a class of widely used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs. Some generic versions of other ARBs, such as valsartan and irbesartan, have also been recalled.

The FDA said increased risk of cancer in patients exposed to the new impurity, NMBA, appeared to be the same as those exposed to NDMA, but less than the risk from NDEA.

The recalls began last year after regulators said ingredients used by Chinese manufacturer Zhejiang Huahai Pharmaceuticals Co to produce valsartan contained cancer-causing impurities.

Since then, generic drugmakers such as Mylan NV, Teva Pharmaceutical and Novartis’ Sandoz have recalled products containing the tainted ingredients.

In January, the FDA warned of the possibility of additional shortages of hypertension drugs in the United States due to the recalls. The FDA also said it is working to develop testing methods to detect other cancer-causing impurities.

newsdailyMay 10, 2019


World Tuberculosis Day is being observed Pakistan today like elsewhere in the world.

Tuberculosis is a potentially serious infectious disease that mainly affects one’s lungs.

The theme of World TB Day this year is “Its time to put the accent on the urgency to act on the commitments made by global leaders to scale up access to prevention and treatment of the disease, build accountability, ensure sufficient and sustainable financing including for research and promote an end to stigma and discrimination, and an equitable, rights-based and people-centered TB response”.

newsdailyMay 10, 2019


NEW YORK (Reuters ) – Experimental contact lenses that not only improve vision, but also ward off itchiness due to allergies, got a boost with the completion of two late-stage studies, according to a new report.

The antihistamine-containing lenses, developed and tested by Johnson & Johnson, significantly quieted eye allergy symptoms, researchers reported in Cornea.

“These are pretty encouraging results,” said coauthor Brian Pall, director of clinical science for Johnson & Johnson Vision Care. “Over 20 percent of people suffer from eye allergies. It has a pretty big impact on their quality of life.”

The two randomized trials – both funded by Johnson & Johnson – tested the effectiveness and safety of lenses that slowly release the antihistamine ketotifen. Together the trials included 244 volunteers whose ages ranged from 12 to 61.

Participants either wore two antihistamine-treated lenses, two regular lenses without the antihistamine, or one of each – but they didn’t know what they were wearing.

After volunteers put the lenses in, they were exposed to allergens that would normally make their eyes itch. They were asked to rate on a scale of zero to four how itchy their eyes were at 15 minutes after the lenses were inserted and 12 hours after insertion. Scores were lower on average, by more than one point on a scale of zero to four, when volunteers had medicated lenses in.

Between the two studies there were 24 adverse events, most of which were mild, the researchers reported. There were two more-severe adverse events that occurred in both eyes of one volunteer, which the researchers described as “excess tearing.”

Some of the volunteers who wore lenses with antihistamine reported no itching, while others reported itching that was bothersome, but tolerable, Pall said.

Pall is very enthusiastic about the new lenses. “We are super excited to have this opportunity to publish on this technology,” he said.

Dr. Christopher Starr welcomed the new findings.

“This is really novel and interesting on a number of levels,” said Starr, an ophthalmologist and professor at NewYork-Presbyterian and Weill Cornell Medicine. “I do treat a lot of patients with seasonal allergies in New York City. Right now they’re bracing for the first peak that comes from April to May.”

Currently Starr advises those patients to put antihistamine drops in their eyes 10 minutes before they put their lenses in. “Then they can wear them throughout the day,” he said. “And then they put a second drop in their eyes after they take the lenses out.”

In fact, Starr said, “my own eyes itch and this is a product that on first glance – with this positive data – is something I would use myself.”

It’s also reassuring that the new product is a combination of two items that have proven track records for safety, Starr said.

Pall says he doesn’t know when the new lenses might show up on store shelves.

“Obviously we are committed to getting all the pieces in place for regulatory submission,” he said. “In my experience it’s very hard to predict how things will go when you start to meet and discuss with regulatory bodies. But we are encouraged by this robust clinical data that would support a submission (for approval) in the future.”

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