Low risk in ‘contaminated’ blood pressure drugs: FDA

Fights youth vaping

WASHINGTON, Aug 29, (AP): US health officials on Wednesday tried to reassure patients that they face very low risks from ongoing contamination problems with widely prescribed blood pressure drugs.

Drugmakers have issued more than 50 recalls since last July linked to low levels of a probable cancer-causing chemical found in generic drugs taken by millions of Americans. The contamination underscores the Food and Drug Administration’s struggle to police an industry that increasingly relies on overseas manufacturing plants in China and India.

On Wednesday, an FDA official said the actual risk to patients from the tainted medications is likely lower than originally stated.

The FDA said last year that if 8,000 patients took the maximum dose of the drugs for four years, the contamination issue could cause one extra case of cancer over their lifetimes.

The agency now says that the actual risk to patients is likely much lower than this “worst case scenario.” That’s because most patients likely “received much smaller amounts of the impurity,” because not all blood pressure drugs on the market contain the hazardous chemicals.

Medication

The FDA’s drug center director, Janet Woodcock, said patients should continue taking their medication, because the risk of untreated high blood pressure and heart failure “greatly outweighs the potential risk of exposure to trace amounts” of contaminants.

The affected medications are low-cost versions of lifesaving heart-regulating drugs, including valsartan, losartan and irbesartan. They are designed to allow blood to flow more easily and are sold as single-ingredient pills and tablets and in combination with other drugs.

The FDA is responsible for ensuring that US medicines are produced in safe, sanitary conditions that meet quality standards. But regulators have struggled for years to inspect the supply chain as pharmaceutical production spread globally.

For decades the FDA focused its manufacturing inspections on US factories. More than 90 percent of the drugs prescribed in the US are generics, and over time, most companies have moved their manufacturing overseas to take advantage of cheaper labor and materials. Today roughly 80 percent of the ingredients used in US medicines are made abroad, according to the Government Accountability Office.

The FDA did not open its first permanent offices in China and India until 2008 and 2009, respectively. That followed dozens of deaths and hundreds of allergic reactions in the US linked to a contaminated blood thinner made at a Chinese facility.

The FDA has tried to keep pace with foreign inspections. But when the GAO’s watchdog investigators last examined the issue in 2016, they estimated the FDA had never inspected nearly 1,000 of the 3,000 foreign manufacturing facilities that export drug ingredients to the US.

Earlier this summer House lawmakers asked the FDA to provide information about its oversight of facilities in China and India linked to the recent recalls.

“We remain concerned about whether FDA has the appropriate resources, policies, management practices, and authorities to oversee adequately foreign drug manufacturing,” wrote members of the House Committee on Energy and Commerce, in a June letter to the FDA.

On Wednesday, Woodcock noted that the FDA recently issued a warning letter to an India-based manufacturer, Lantech Pharmaceuticals, over traces of a carcinogen found at one of its facilities. The FDA said the company failed to “control and monitor” its manufacturing to prevent the chemical from making its way into pharmaceutical shipments.

The FDA notes that 43 blood pressure medications have not been affected by the contaminations issues. No drug shortages have been reported due to the issue, the agency noted .

North Carolina’s top prosecutor expanded his efforts to halt ecigarette sales to teens on Tuesday by suing eight more manufacturers and sellers of vaping products.

Josh Stein, the Democratic attorney general in the traditionally tobacco-friendly state, said he’s filing lawsuits against eight companies that make or sell ecigarettes and related products in an announcement timed to grab attention during the first week of school.

He alleges that the companies market to young people with candy and dessert flavors on social media and don’t use proper age verification for sales. He said he’s asking courts to shut down their marketing and sales to underage people.

“We simply have to do more to protect kids, and I as attorney general of North Carolina refuse to stand by as e-cigarette companies entice thousands of children to use their products,” Stein told reporters.

He said vape flavors including cotton candy, gummy bear and graham cracker are helping to fuel an “epidemic” of e-cigarette use among young people and threatening to reverse a downward trend in tobacco use in North Carolina and around the country.

Addicted

“We simply cannot have another generation of young people addicted to nicotine,” he said.

Stein said the new lawsuits target the companies Beard Vape, Direct eLiquid, Electric Lotus, Electric Tobacconist, Eonsmoke, Juice Man, Tinted Brew and VapeCo.

Electric Tobacconist USA CEO Bruce Gibson issued a statement Tuesday saying that the online store uses “extensive” age verification run by a third party that employs driver’s license, voter registration and other records to check that buyers are adults.