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. said it might be tainted by N-nitrosodimethylamine (NDMA), considered a probable human carcinogen. 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. Three companies that sell the generic drug, valsartan, in the United States agreed to recall it after the F. The agency is still investigating, but said the contamination was believed to be related to changes in the way that valsartan was manufactured. “That is why we’ve asked these companies to take immediate action to protect patients.”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. Their health care provider should be able to offer other treatment options, among them, another valsartan product that is not part of the recall. All of the valsartan that is being recalled was made in China by the same company, Zhejiang Huahai Pharmaceutical Co. It is distributed in the United States by three companies: Major Pharmaceuticals; Teva Pharmaceutical Industries, Ltd.; and Solco Healthcare. If the information is not there, patients should contact the pharmacy where they got it, the F. 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. 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, 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. Brito, “but we believe this could get offset by other players stocking up in short term. Solco declined to comment, but in a news release, acknowledged that the recall stemmed from detection of a trace amount of NDMA. Switch options are available for a hypertension patient.”The safety of imported drugs has long been debated. 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. The recall, which also includes valsartan-hydrochlorothiazide tablets, followed a similar action taken by the European Medicines Agency. 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. “It’s becoming very difficult for me to write prescriptions at all. metformin dose for diabetes The FDA Alert(s) below may be specifically about clonidine or relate to a group or class of drugs which include clonidine. Med Watch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Nov 14, 2018Audience: Patient, Caregiver, Health Professional, Pain Management, Pharmacy, Neurology, Surgery ISSUE: The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump. 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Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. Catapres is a prescription alpha-agonist hypotensive agent used to treat high blood pressure. Please complete all the fields below to send the bad drug report. Each field is required to be completed in order to send. The submission of this form does not form an attorney client relationship. Food and Drug Administration released information stating that Clonidine does pass through the placental barrier and can be passed through breast-milk. It is unknown if using Clonidine during pregnancy or breatfeeding will harm the baby. An attorney client relationship will only be formed after the execution and return of a retainer agreement. Let your doctor know if your are pregnant, breastfeeding or plan to become pregnant before taking Clonidine. 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