BREAKING NEWS : Indiana coronavirus cases increase to 74,328; 2,835 deaths Full Story
BREAKING NEWS : Allen County reports 68 new COVID-19 cases Full Story

Blood pressure medication recall expands again to include losartan

A widespread recall of common blood pressure and heart failure medications has been expanded to include more drugs containing losartan. The recall is due to...

Posted: Mar 3, 2019 8:29 AM

A widespread recall of common blood pressure and heart failure medications has been expanded to include more drugs containing losartan. The recall is due to an "impurity" that is classified as a potential human carcinogen.

The impurity, N-Nitroso-N-methyl-4-aminobutyric acid or NMBA, is also classified as a known animal carcinogen, the US Food And Drug Administration noted in a news release about the recall Friday.

Camber Pharmaceuticals Inc. voluntarily recalled 87 lots of losartan tablets in the United States on Thursday. The recalled tablets, made by Hetero Labs Ltd. In India and distributed by Camber Pharmaceuticals, were found to contain trace amounts of the impurity.

The recall noted that Camber has not received any reports of adverse events related to the recall.

The recall is the latest in an ongoing investigation into a class of drugs known as angiotensin receptor blockers or ARBs, which contain either valsartan, losartan or irbesartan and are used in patients with high blood pressure and other conditions.

Starting in July, separate lots of ARB blood pressure and heart failure medications from various companies were recalled around the world, including in the United States, due to containing similar impurities that are potential or suspected human carcinogens: N-nitrosodimethylamine or NDMA and N-nitrosodiethylamine or NDEA.

Recent FDA analyses of NDMA and NDEA in the recalled drugs have found that "overall, the risk to individual patients is very low," but the agency added that those findings don't diminish the significance of this issue and that it continues to evaluate the risks posed to patients.

Now, the FDA is "deeply concerned" about the presence of a third impurity in certain ARB medications, Commissioner Dr. Scott Gottlieb said in the news release. NMBA had not been found in previously recalled ARB products, but the FDA continues its investigations.

"It's important to underscore that, based on the FDA's initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure. That said, any presence of such impurities in drug products is not acceptable. Over the past few months, the FDA has conducted a major investigation and has worked with drug companies to address the presence of impurities in these products," Gottlieb said.

"Our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug's active pharmaceutical ingredients. FDA scientists have developed novel and sophisticated testing methods specifically designed to detect and measure N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities in ARB medicines. Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA," he said.

"We're continuing to share these testing methods with international regulators, industry and the public to help manufacturers and other regulators evaluate these products for any potential nitrosamine impurity."

There are FDA safeguards in place to prevent drug contamination, Maisha Kelly Freeman, a professor and director of Samford University's Center for Healthcare Innovation and Patient Outcomes Research, said this week.

Manufacturers are compelled to report impurities, for example, and the agency inspects factories on a risk-prioritized basis. However, there's a catch.

"Obviously, if they're not looking for it, they don't really know that it's occurring," Freeman said. And that's what happened in the case of tainted ARBs.

"Before they found this particular compound, they didn't even know there could be a chemical reaction that could produce the compound," she said.

Regarding how the recall has affected patients and pharmacists, "most patients have to come in and get their medications changed out" to lots of medication that have not been affected, Freeman said. Other people are getting their prescriptions changed.

From a community pharmacy perspective, this recall has been difficult because many pharmacies don't keep the lot numbers of medications after they're dispensed, Freeman said: "That information is not tracked effectively."

She hopes that in the next few years, technologies such as bar codes will be in place to help identify affected patients.

As for the latest recall, the FDA has reminded patients prescribed an ARB medication from a recalled lot to continue taking their medicine until their doctor or pharmacist provides a replacement or offers a different treatment option. Patients also are encouraged to talk to their doctor or pharmacist as soon as possible.

According to the FDA, "Not all ARB products contain NDMA, NDEA or NMBA impurities, so pharmacists may be able to provide an alternative medication not affected by the recalls, or health care professionals may prescribe a different medication that treats the same condition."

Indiana Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 73287

Reported Deaths: 3036
CountyConfirmedDeaths
Marion15701725
Lake7496275
Elkhart480184
Allen3835163
St. Joseph342381
Hamilton2723104
Vanderburgh192213
Hendricks1871108
Cass17869
Johnson1741118
Porter129439
Clark120247
Tippecanoe118911
Madison94365
LaPorte89430
Howard88465
Kosciusko84712
Bartholomew78047
Marshall77422
Floyd77246
Monroe74630
Delaware71452
Dubois68712
Boone67246
Noble66329
Hancock64738
Vigo61910
Jackson5855
Warrick57930
LaGrange55710
Shelby54627
Grant52630
Dearborn49628
Morgan46734
Clinton4303
Henry37620
Wayne36810
White36110
Montgomery35221
Lawrence34227
Decatur33532
Harrison32723
Putnam2868
Miami2692
Scott26610
Daviess26420
Greene24634
Franklin24114
Jasper2342
DeKalb2304
Jennings22412
Gibson2214
Steuben2073
Ripley1997
Fayette1867
Carroll1852
Perry18412
Starke1777
Posey1700
Orange16924
Wabash1653
Fulton1642
Wells1622
Jefferson1602
Knox1510
Whitley1516
Washington1391
Tipton1379
Spencer1313
Huntington1223
Newton11810
Randolph1184
Clay1165
Sullivan1131
Adams962
Jay910
Owen871
Pulaski791
Rush764
Brown731
Fountain732
Blackford632
Ohio635
Benton610
Pike530
Parke511
Vermillion490
Switzerland460
Crawford440
Martin430
Union390
Warren221
Unassigned0202

Ohio Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 99969

Reported Deaths: 3668
CountyConfirmedDeaths
Franklin18182523
Cuyahoga13414499
Hamilton9583255
Lucas5288323
Montgomery431894
Summit3523222
Marion292245
Butler289163
Mahoning2532255
Pickaway238342
Stark1813139
Warren176739
Lorain173678
Columbiana165660
Trumbull1518106
Fairfield136732
Delaware129219
Licking126049
Clark114214
Lake111138
Wood103058
Clermont92111
Medina91435
Miami83238
Tuscarawas78114
Portage75461
Allen73244
Greene68412
Belmont62126
Mercer60513
Richland60012
Erie57027
Ashtabula56246
Geauga55444
Wayne52958
Ross4684
Huron3955
Darke39329
Ottawa37726
Sandusky37316
Hancock3723
Athens3561
Madison35510
Holmes3276
Lawrence2790
Auglaize2506
Union2461
Muskingum2251
Jefferson2242
Scioto2241
Putnam20517
Seneca2043
Knox2037
Washington20222
Preble2012
Coshocton1926
Shelby1904
Crawford1745
Champaign1732
Morrow1682
Hardin16412
Clinton1626
Highland1561
Logan1522
Fulton1471
Wyandot1458
Ashland1433
Defiance1424
Williams1343
Brown1272
Perry1233
Guernsey1167
Henry1162
Hocking1169
Fayette1120
Carroll1115
Monroe9118
Pike760
Jackson740
Van Wert711
Paulding670
Gallia651
Adams592
Meigs380
Vinton312
Harrison261
Morgan250
Noble170
Unassigned00
Fort Wayne
Scattered Clouds
86° wxIcon
Hi: 88° Lo: 66°
Feels Like: 90°
Angola
Few Clouds
84° wxIcon
Hi: 87° Lo: 67°
Feels Like: 88°
Huntington
Scattered Clouds
83° wxIcon
Hi: 86° Lo: 66°
Feels Like: 87°
Decatur
Clear
82° wxIcon
Hi: 87° Lo: 66°
Feels Like: 85°
Van Wert
Clear
82° wxIcon
Hi: 86° Lo: 66°
Feels Like: 85°
Sunny, Seasonable Saturday
WFFT Radar
WFFT Temperatures
WFFT National

Community Events