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News Archives

FEBRUARY 25, 2019: Xeljanz Side Effects – Increased Risk Of Pulmonary Embolism And Death With Higher Dose Of Tofacitinib (Xeljanz And Xeljanz XR) In Rheumatoid Arthritis Patients Reported

Increased Death and PE Risk Observed in Xeljanz (tofacitinib) Post Marketing Study Xeljanz Side Effects – The US Food and Drug Administration (FDA) announced on February 25, 2019, that data from an ongoing post marketing study has demonstrated an increased risk of pulmonary embolism (PE) and death in rheumatoid arthritis (RA) patients treated with a 10 mg twice daily dose of tofacitinib (marketed as Xeljanz, Xeljanz XR). The FDA has not approved the 10 mg twice daily dose of tofacitinib for rheumatoid arthritis; however, this dose is approved in the treatment of ulcerative colitis. Tofacitinib (Xeljanz, Xeljanz XR) Post Marketing Study Requirement At the time of marketing approval, the FDA required Xeljanz manufacturer, Pfizer, to conduct a post marketing study in patients with RA to evaluate the risk of cardiovascular events, cancer, and opportunistic infections. The study followed patients taking Read More

August 31, 2018: FDA Announces Recall Montelukast Tablet Recall For Incorrect Drug In Bottles

FDA Montelukast Tablet Recall Announcement The U.S. Food and Drug Administration(FDA) is warning consumers and health care professionals of a recall for one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., of Piscataway, N.J. According to the FDA announcement, the Montelukast Tablet Recall was initiated because sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg. FDA Statement Regarding The Montelukast Tablet Recall This tablet mix-up may pose a safety risk as taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels and low blood pressure. This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood Read More

August 27, 2018: Accord Healthcare Recalls Hydrochlorothiazide Tablets – One Lot

Accord Healthcare Recalls Hydrochlorothiazide Tablets Accord Healthcare Inc., has recalled one lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, due to a potential product labeling error. Specifically, a 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg was found to contain 100 Spironolactone Tablets USP 25 mg, according to the company’s recall announcement. Accord Healthcare became aware of the mix-up through a product complaint reported from a pharmacy. About Spironolactone and Hydrochlorothiazide Accord Healthcare provided the following medication information to consumers: “Spironolactone tablets are indicated in the management of primary hyperaldosteronism, edematous conditions for patients with congestive heart failure, cirrhosis of the liver accompanied by edema and/or ascites, nephrotic syndrome, essential hypertension, hypokalemia, severe heart failure. Use of spironolactone tablets instead of hydrochlorothiazide tablets, poses the risk of contracting hyperkalemia (increase potassium levels) in Read More

August 3, 2018: FDA Warns For Increased Risk of Cancer Relapse With Long-term Use of Azithromycin After Stem Cell Transplant

Azithromycin Safety Announcement – In a Safety Announcement dated August 3, 2018, The U.S. Food and Drug Administration (FDA) warned that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. The announcement was made after results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. The FDA is reviewing additional clinical data regarding this matter, and will communicate their findings and recommendations when the review is complete. Azithromycin Manufacturer Issues “Dear Healthcare Provider Letter” The FDA Safety Announcement stated: “The serious lung condition for which long-term azithromycin was being studied called bronchiolitis obliterans syndrome is caused by inflammation and scarring in Read More

July 13, 2018: FDA Announces Valsartan Recall Due To Detection Of Impurity

Detection Of Impurity Prompts Valsartan Recall On July 13, 2018, the FDA alerted health care professionals and patients of a recall for multiple drug products containing the active pharmaceutical ingredient, valsartan, because the products contained an impurity known as N-nitrosodimethylamine (NDMA). Not all products containing valsartan are subject to the valsartan recall. The FDA cautioned that “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.” Valsartan Recall Information for Patients and Health Care Professionals Valsartan is prescribed to treat high blood pressure and heart failure. The FDA has provided health care professional and the public with the following safety information. Patients should neither start nor stop taking Read More

February 22, 2018: FDA Cautions – Potential For Increased Long-term Risks With Clarithromycin Use In Patients With Heart Disease

FDA Cautions – Potential For Increased Long-term Risks With Clarithromycin Use In Patients With Heart Disease In a Safety Announcement dated February 22, 2018, the U.S. Food and Drug Administration (FDA) advised caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. The FDA based its recommendations on a review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed this safety issue. The FDA has added a new warning about this increased risk of death in patients with heart disease, and advised prescribers to consider using other antibiotics in these patients. The study results were also added to the clarithromycin drug labeling. The FDA will continue to monitor safety Read More

August 1, 2017: Rugby Laboratories Diocto Liquid and Diocto Syrup Recalled For Potential B. Cepacia Contamination

Docusate – B. Cepacia Lawsuit Help The Weinberg Law Firm represents victims of the 2016 Burkholderia cepacia outbreak linked to contaminated docusate liquid use. If you or a loved one has been injured by a contaminated docusate product and you would like information regarding a docusate lawsuit, please call The Weinberg Law Firm toll free at 1-877-934-6274. Our phones are answered 24/7. Rugby Laboratories Ducosate Recall Rugby Laboratories has recalled all lots of its Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech, LLC due to potential Burkholderia cepacia contamination. The recall was initiated after the Food and Drug Administration (FDA) informed Rugby that it had received several adverse event reports of B. cepacia infections in patients that may be linked to Diocto Liquid or Diocto Syrup manufactured by PharmaTech LLC. Diocto Liquid and Diocto Syrup are used Read More

March 15, 2017: FDA Warns Of Increased Viberzi Pancreatitis Risk In IBS Patients Without A Gallbladder

FDA Warns Of Increased Viberzi Pancreatitis Risk In IBS-D Patients Without A Gallbladder In a Drug Safety Communication dated March 15, 2017, The U.S. Food and Drug Administration (FDA) warned that Viberzi (eluxadoline), should not be used in patients who do not have a gallbladder. The warning was made after an FDA review found that these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. The FDA stated that it is working with the manufacturer of Viberzi, Allergan, to address these safety concerns. What Is Viberzi? Viberzi is medication prescribed to treat irritable bowel syndrome with diarrhea (IBS-D). Viberzi was approved in the U.S. in 2015. FDA Viberzi Pancreatitis Risk Information For Patients The FDA advised patients Read More

November 09, 2016: State Legislative Conference Addresses Painkiller Abuse

2016 State Legislative Conference on Painkiller Abuse From October 27th to 29th the American Academy of Family Physicians (AAFP) held a State Legislative Conference to discuss the way the federal and state governments have addressed the issue of the painkiller abuse epidemic. According to the U.S. Centers for Disease Control and Prevention, sales of prescription opioids in the U.S. nearly quadrupled from 1999 to 2014; deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methadone- have also quadrupled since 1999. Painkiller Abuse and Heroin Addiction In Arizona, from 2005 to 2015, pain killers were the cause of significantly more deaths than deaths attributed to other drugs. In 2015, 405 deaths were caused by pharmaceutical painkiller overdose compared with 237 heroin-related deaths. According to Cara Christ, M.D., M.S., director of the Arizona Department of Health Services, “Seventy-five percent of heroin users started Read More

October 24, 2016: FDA Reports Progress in Opioid Abuse Action Plan

On October 24, 2016, FDA Voice provided an update on the progress of the U.S. Food and Drug Administration (FDA) Opioid Abuse Action Plan. According to Robert M. Califf, M.D., the Deputy Commissioner of the United States Food and Drug Administration’s Office of Medical Products and Tobacco, the plan to address problems with opioid abuse has made significant strides. CONTACT THE WEINBERG LAW FIRM FOR A FREE DRUG LAWSUIT CASE EVALUATION Attorney Eric H. Weinberg has played a significant role in multiple mass tort litigations against corporate pharmaceutical defendants. He has represented plaintiffs in high profile drug lawsuits including Pradaxa, Vioxx, Baycol, and blood clotting products. For a free drug lawsuit evaluation, please call us toll free at 1-877-934-6274, or submit the easy-to-use Free Legal Case Evaluation Form. Our phones are answered 24/7. FDA Opioid Abuse Action Plan Progress At Read More

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