GOV/MIL Losartan Potassium, Hydrochlorothiazide & Valsartan Recall

O

Old Gray Mare

TB Fanatic
Fair use.

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)


Announcement

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

To date, Sandoz Inc. has not received any reports of adverse events related to this lot.

Losartan Potassium Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. The product can be identified as Losartan Potassium Hydrochlorothiazide, 100 mg/25 mg tablets in 1000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020. This product was distributed nationwide to distributors. The affected product was not distributed prior to October 8, 2018.

Sandoz Inc. is notifying its distributors by letter via overnight mail and patients by this public notification. Distributors and retailers that have product which is being recalled should immediately stop distribution of the identified lot above and quarantine any quantities remaining in your control and return the recalled product to the identified Reverse Distributor.

Patients with questions regarding this recall can contact Sandoz Inc. at 1-800-525-8747 Monday-Friday 8:30 AM – 5:00 PM (EST) or email usdrugsafety.operations@novartis.com. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on Losartan Potassium Hydrochlorothiazide should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Losartan Potassium Hydrochlorothiazide.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being made with the knowledge of the Food and Drug Administration.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2017 sales of USD 10.1 billion. In 2017, our products reached more than 500 million patients. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

link to source:
https://www.fda.gov/Safety/Recalls/ucm625492.htm
 
Last edited:
Bones

Bones

Living On A Prayer
Good scare for me! I do take Losartan HCTZ, but not by that manufacturer.

Side note: Taking a whole pill makes me have severe lightheadedness. Half a pill and my BP elevates. My Dr had now changed the med to Losartan without the hydrochlorothiazide diuretic.
 
CaryC

CaryC

Has No Life - Lives on TB
Thanks for this post, even though it had me scrambling for a couple of minutes.

Nothing matched, so I'm good. Well I'm not good, or I wouldn't be taking the meds, but I think you understand.
 
Squib

Squib

Veteran Member
I take that also.

Got a letter from our local pharmacy concerning it...problem was, I’d finished almost the entire bottle already.
 
O

Old Gray Mare

TB Fanatic
Looks like Losartan may have been one of the go to drugs when Valsartan was recalled?

Fair use

Valsartan recall: 4 things patients should know
CNN Digital Expansion 2016 Jacqueline Howard
Updated 12:05 AM ET, Thu November 1, 2018

By Jacqueline Howard, CNN

(CNN)Several common drugs that contain valsartan, used to treat high blood pressure and heart failure, have been recalled in the United States due to an "impurity" in the drug that poses a potential cancer risk.
That impurity, N-nitrosodimethylamine or NDMA, is classified as a probable human carcinogen, based on results from lab tests.

The medicines included in the voluntary recall are valsartan from Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries, as well as valsartan/hydrochlorothiazide from Solco and Teva.

FDA expands recall of blood pressure drug valsartan due to cancer concern

The medicines that have been recalled as of October 24 are sold by Teva Pharmaceuticals labeled as Major Pharmaceuticals, Prinston Pharmaceutical Inc. labeled as Solco Healthcare LLC, Teva Pharmaceuticals USA labeled as Actavis, AvKARE (Teva/Actavis), RemedyRepack Inc. (Prinston/Solco), A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco), Bryant Ranch Prepack Inc. (Teva/Actavis), H J Harkins Company Inc. dba Pharma Pac (Prinston/Solco), Northwind Pharmaceuticals (Teva/Actavis), Hetero Labs, Inc. labeled as Camber Pharmaceuticals, Inc., NuCare Pharmaceuticals Inc. (Prinston/Solco), RemedyRepack, Inc. (Hetero/Camber), AvKARE (Hetero/Camber), Preferred Pharmaceuticals, Inc. (Hetero/Camber), Torrent Pharmaceuticals Limited, and RemedyRepack, Inc. (Torrent).
Additional information about the specific recalled products, including doses, lot numbers and expiration dates, is detailed on the FDA's website.

Valsartan is off patent and is used as a component of other generic medicines, but not all medicines containing the ingredient are involved in the recall.

The US Food and Drug Administration noted in a news release that "the presence of NDMA was unexpected" and thought to be related to changes in the way the active substance was manufactured.
"Our drug shortages team is also working hard to ensure patients' therapeutic needs are met in the United States with an adequate supply of unaffected medications," FDA Commissioner Dr. Scott Gottlieb said in the statement.
FDA joins 22 countries' recall of common heart drug

FDA joins 22 countries' recall of common heart drug
The FDA action came after 22 other countries issued recalls involving 2,300 valsartan batches sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta.
Now, the US recall has left some patients who take valsartan-containing drugs scratching their heads over what to do about their treatment regimens.

"Their biggest concern is about their risk of cancer and better understanding how concerned they should be," said Dr. Suzanne Steinbaum, director of women's cardiovascular prevention, health and wellness at Mount Sinai in New York and a spokeswoman for the American Heart Association.
"They are asking if there is any testing that should be done. Patients are now asking if they should only request 'brand-name' medication instead of generic in order to make sure that this doesn't happen. Lastly, they all want to stop the medication," Steinbaum said, noting that's not the correct action to take.
Experts offered four main takeaways for patients in the wake of the recall.

Not all valsartan drugs have the 'impurity'
In general, not all medications containing valsartan are included in the recall, because not all valsartan-containing medicines were provided the valsartan supply linked to the NDMA "impurity."
Since the recall, the external supplier linked to the problem has stopped distributing its valsartan ingredient, and the FDA has been working with the affected companies to reduce the chances of such a recall occurring in future products, according to the agency.

Why is high blood pressure a 'silent killer'? 01:29
In the meantime, "there are other medications that contain valsartan, some in combination with amlodipine, and those do not appear to be part of the recall," said Dr. Gregory Prokopowicz, director of the Johns Hopkins Hypertension Center and assistant professor of medicine at the Johns Hopkins University School of Medicine.
Amlodipine can be used alone or in combination with other medications to treat high blood pressure and chest pain.
"It's also important to know that the medication Entresto -- that's made by Novartis that contains valsartan and sacubitril and is for heart failure -- is not affected by the recall," he said. "So patients taking that medication should not stop their medication."

The recall does not affect any Novartis or Sandoz valsartan products in the United States or any Novartis Pharma products that contain valsartan, according to a statement from the company.
Common heart drug recalled in 22 countries for possible cancer link
Common heart drug recalled in 22 countries for possible cancer link
"The valsartan API (active pharmaceutical ingredient) in these products does not come from the same source as those products affected outside the United States," the statement said, as specific batches of Sandoz valsartan and Sandoz valsartan and hydrochlorothiazide film-coated tablets were recalled outside the US this month.
Patients in the US taking those valsartan medications or Diovan, Diovan HCT, Exforge, Exforge HCT or Entresto should continue as directed by their physicians, the statement said.

The FDA noted that patients should look at the drug name and company name on the labels of their prescription bottles to determine whether their medicine has been recalled. If the information is not on the bottle, patients should call their pharmacy for those details.

Valsartan alternatives are available
"Patients taking the recalled valsartan-containing medicines should consult their doctor or pharmacist and continue taking their medicine until they have a replacement product," Steinbaum said.
"The conditions the medication treat -- heart failure and high blood pressure -- are serious, and patients could be harmed if they suddenly stop taking it without a replacement prescription," she said.
A health care professional could help provide information about other valsartan-containing products or alternative treatment options.

Patients "could switch to a different generic manufacturer. Or they could switch to another medication in the same class of drugs. The class of drugs is known as angiotensin receptor blockers, or ARBs," Prokopowicz said.
"There are eight drugs on the market in that category. So there's a number of drugs to which they could be switched, other than valsartan. Examples are losartan, irbesartan, olmesartan, and there are a number of others," he said. "In addition to the ARB drugs, there are many, many other blood pressure drugs that could be easily and safely substituted for valsartan, even outside of that category. So it varies from patient to patient."
Check, change, and control your blood pressure

Check, change, and control your blood pressure 02:36
Those patients who have switched to a different drug should monitor their blood pressure closely, said Dr. Erin Michos, an associate professor and associate director of preventive cardiology at Johns Hopkins Medicine.
"It is possible their blood pressure might respond differently to the new medication and doses might need to be adjusted under the guidance of their health care provider," said Michos, whose own patients have been asking her about the valsartan recall.

"Whenever changing or adjusting new blood pressure medications, I recommend that patients keep a log with their blood pressure numbers and time of day the measurement was taken, and share this log with their health care provider to review and make adjustments," she said. "I am mostly just switching my patients off valsartan to another ARB; that is the easiest solution."

What is the valsartan cancer risk?
As of now, the long-term risks posed by the NDMA found in certain valsartan-containing drugs remain somewhat unknown, and the amount of NDMA consumed would play a role in those risks, Michos said.
In other words, "the dose makes the poison," she said.

"What we know about the dangers of this impurity comes primarily from laboratory studies. It is a toxin that can affect the liver and cause liver fibrosis or scarring and liver tumors in rats. So it is assumed to be toxic to humans, as well," Michos said.
"In these animal studies, they usually give large quantities, so again, the risk is likely not the same equivalent in humans," she said.
7 more substances classified as human carcinogens

NDMA, an organic chemical that forms in both industrial and natural processes, has been used to make liquid rocket fuel, softeners and lubricants, among other products. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.
Exposure to high levels of NDMA may cause liver damage in humans, according to the US Environmental Protection Agency.
"I definitely am switching my patients off this medication if supplied by one of the affected companies," Michos said. "I am certainly concerned, but I think it is too soon to panic. This recall is a precaution for safety."
Nearly half of Americans now have high blood pressure, based on new guidelines
Nearly half of Americans now have high blood pressure, based on new guidelines
To put the recall in perspective, Dr. Howard Weintraub, a cardiologist and professor of medicine at NYU Langone Health, said that he told his patients about a meta-analysis study on angiotensin receptor blockers in general and cancer risk.
That study, published in the journal Medicine in 2016, involved analyzing data from 19 randomized controlled trials including 148,334 patients.

"Looking at all of those trials that were conducted with a variety of these medications within the ARB family, there was no hint of a cancer risk," said Weintraub, who was not involved in the study.
"It was a very well-done analysis of older trials, and there was no ambiguity that there was not a signal of cancer risk," he said.

'Taking medicines is not a substitute for a good lifestyle'
Overall, the conversation around valsartan-containing medications is a reminder for patients to be mindful of maintaining healthy habits along with their medication regimen, Weintraub said.
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It's important to continue taking prescriptions provided by your doctor, but "taking medicines is not a substitute for a good lifestyle," he said.

"You and your health care physician or practitioner should work together on making sure that you keep an eye on your weight. Keep an eye on your diet, particularly your salt intake, and try to exercise regularly," he said. "Each of those individually and together can have a significant impact on your blood pressure."

CNN's Jen Christensen contributed to this report.

Link to source:
https://www.cnn.com/2018/07/19/health/valsartan-recall-explainer/index.html
 
H

Housecarl

On TB every waking moment
Here we go again...….

For links see article source.....
Posted for fair use.....
https://www.msn.com/en-us/health/me...ed-for-cancer-risk/ar-BBUesGq?ocid=spartanntp

87 lots of popular blood pressure medication recalled for cancer risk

Joel Shannon
1 hr ago

Camber Pharmaceuticals, Inc. recalled 87 lots of the blood pressure medication losartan on Thursday after discovering trace amounts of a potential carcinogen.

The recalled 25 mg, 50 mg and 100 mg tablets contained small amounts of N-Nitroso N-Methyl 4-amino butyric acid, or NMBA, according to a company recall notice posted on the Food and Drug Administration's website. It's the second losartan recall in a week; Macleods Pharmaceuticals Limited recalled a single lot on Feb. 22.

Camber says the medication was nationally distributed to retail and mail-order pharmacies, in addition to wholesalers and distributors.

"To date, Camber has not received any reports of adverse events related to this recall," the release says.

The medication is packaged in 30 count, 90 count, 500 count and 1000 count bottles. A full list of recalled medications is available from the FDA.

The release says that consumers should continue taking the product until receiving guidance from their doctor.

The active drug ingredient was made at Hetero Labs Limited in India, one of two overseas drug factories linked to repeated blood medication recalls since last July.

There have been more than a dozen recalls of versions of the blood pressure and heart medications losartan, valsartan and irbesartan that contained trace amounts of probable carcinogens.

The recalled drugs are part of a large class of drugs called angiotensin II receptor blockers, or ARBs, which work by relaxing the blood vessels.
 
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