Advertisement
  1. Health

Popular blood pressure medicine made in China is recalled

Margaret Graham, 74, has her blood pressure checked while visiting the Wake Forest Baptist Medical Center in Winston-Salem, N.C., on Friday, July 13, 2018. The Food and Drug Administration has announced a voluntary recall of a widely prescribed blood pressure medication made in China, reviving fears about the safety of imported drugs. [Associated Press]
Published Aug. 7, 2018

The Food and Drug Administration has announced a voluntary recall of a widely prescribed blood pressure medication made in China, reviving fears about the safety of imported drugs.

Three companies that sell the generic drug, valsartan, in the United States agreed to recall it after the FDA said it might be tainted by N-nitrosodimethylamine (NDMA), considered a probable human carcinogen. The agency is still investigating, but said the contamination was believed to be related to changes in the way that valsartan was manufactured.

All of the valsartan that is being recalled was made in China by the same company, Zhejiang Huahai Pharmaceutical Co. Ltd. It is distributed in the United States by three companies: Major Pharmaceuticals; Teva Pharmaceutical Industries, Ltd.; and Solco Healthcare. Solco, which is owned by Huahai Pharmaceutical, had about 45 percent of the market in 2017, according to John Brito, of Fore Pharma, the market research firm.

"We have carefully assessed the valsartan-containing medications sold in the United States, and we've found that the valsartan sold by these specific companies does not meet our safety standards," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "That is why we've asked these companies to take immediate action to protect patients."

RELATED: Study: Lowering blood pressure helps prevent mental decline

The agency advised patients taking the drug to look at the manufacturer's name on the label of their prescription bottle to determine if it is part of the recall. If the information is not there, patients should contact the pharmacy where they got it, the FDA said.

The agency also said that patients taking valsartan, or medicines that use it as an ingredient, should continue taking it until they have a substitute. Their health care provider should be able to offer other treatment options, among them, another valsartan product that is not part of the recall. Other companies that market the drug, not subject to the recall, are Sun Pharma, Mylan, Jubiliant, Aurobindo and Hetero, according to Fore Pharma.

"The recall is huge, based on the volume and the large number of patients it could have impacted," said Mr. Brito, "but we believe this could get offset by other players stocking up in short term. Switch options are available for a hypertension patient."

The safety of imported drugs has long been debated. The FDA said it would continue to investigate the levels of NDMA in the recalled products, determine the possible effect on patients who have been taking them, and assess what measures can be taken to reduce or eliminate the impurity from future batches.

Solco declined to comment, but in a news release, acknowledged that the recall stemmed from detection of a trace amount of NDMA. A spokesman for Major Pharmaceuticals said they were recalling several lots and referred other questions to Teva, which supplies valsartan that they package and sell. Teva did not return calls for comment.

The recall, which also includes valsartan-hydrochlorothiazide tablets, followed a similar action taken by the European Medicines Agency.

Dr. Harry Lever, a cardiologist at the Cleveland Clinic, said he was concerned about quality control of generic medicines, like valsartan, made in China and India. He believes that manufacturers should be more transparent about where their active ingredients are made.

"It's not just valsartan," Dr. Lever said. "It's becoming very difficult for me to write prescriptions at all. There are so many drugs that are coming in from India and China and companies are buying and selling each other and you don't know what's what."

ALSO IN THIS SECTION

  1. An opened capsule containing Kratom. The Clearwater City Council was confronted by dozens of concerned citizens at a recent meeting who urged them not to ban the herbal supplement. Times
    “Our recommendation right now is, we don’t think there’s a need to regulate it.”
  2. BayCare Health Systems now plans to build a $200 million, 60-bed hospital along Bruce B. Downs Boulevard. The company previously planned to build on 111 acres further north adjacent to Interstate 75 and an interchange to built at Overpass Road. Shown his the main entrance to BayCare's St. Joseph's Hospital North on Van Dyke Road in Lutz. Times
    BayCare plans a $200 million, 60-bed hospital on land it owns along Bruce B. Downs Boulevard
  3. An analysis by the Kaiser Family Foundation shows that two-thirds of Medicare Part D beneficiaries, or about 9 million people who don’t receive low-income subsidies, will see their monthly premium increase for next year if they stay in their current plan. To sort through your options, visit the Times' Medicare guide at tampabay.com/news/health or contact Serving Health Insurance Needs of Elders, a state program commonly known as SHINE. Contact them at 1-800-963-5337 or information@elderaffairs.org. MICHELE MILLER  |  Tampa Bay Times
    About 9 million people with Medicare Part D plans will see higher premiums if they don’t make a change before Dec. 7, a new study says.
  4. "Doctor" Jeremiah Corouthers, 8, puts a cast on a teddy bear with child life specialist Amanda Petryszak during the annual Doctors for a Day event in March at St. Joseph's Children's Hospital in Tampa. The burden of caregiving is increasingly falling on Florida families, according to an AARP report. MONICA HERNDON  |  Times
    There are nearly 3 million caregivers in Florida helping care for relatives, and it’s costing them time and money. But some help is on the way.
  5. Pharmacist Wendy Sullivan gives a flu shot to Luz Acevedo at the Town 'N Country Senior Center in 2012. The 2019-20 flu season is expected to be a hard one, with Hillsborough County already leading the state in outbreaks. Associated Press
    The county leads the state in flu outbreaks so far this season, prompting an official call for parents to get their kids vaccinated.
  6. An opened capsule containing Kratom. The Clearwater City Council was confronted by dozens of concerned citizens at a recent meeting who urged them not to ban the herbal supplement. Times
    “I think there was a misunderstanding."
  7. Dr. Philip Adler treated generations of Tampa children, including Hannah Millman, who was 2 years old at the time of this visit. Times (1985)
    The Tampa pediatrician also played a prominent role in desegregating local hospital care.
  8. Reginald Ferguson, center, a resident of the Kenwood Inn in St. Petersburg, talks with Rachel Ilic, an environmental epidemiologist, left, and Fannie Vaughn, right, a nurse with the Florida Department of Health in Pinellas County. The health team was encouraging residents to get vaccinated against hepatitis A, part of a larger effort to address an outbreak of the virus in Florida. SCOTT KEELER  |  Tampa Bay Times
    The effort started in Pinellas, where health department “foot teams” are knocking on doors in neighborhoods at higher risk for the virus.
  9. A nurse at Tampa General Hospital holds a special stethoscope used for critical patients in the Jennifer Leigh Muma Neonatal Intensive Care Unit there. The hospital received a C grade from Leapfrog, an independent nonprofit which ranks hospitals nationally for patient safety. Times (2018)
    Leapfrog, an independent nonprofit, rated hospitals based on hand washing, infection rates, patient falls and other factors.
  10. Most of the time (55%), older spouses are caregiving alone as husbands or wives come to the end of their lives, without help from their children, other family members or friends or paid home health aides, according to research published earlier this year. [Times (2011)]
    Compared to adult children who care for their parents, spouses perform more tasks and assume greater physical and financial burdens when they become caregivers.
Advertisement
Advertisement
Advertisement