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News Archives

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

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

October 12, 2016: FDA Finds Outbreak Bacteria in PharmaTech Docusate

According to an October 12, 2016 FDA Update, the bacteria Burkholderia cepacia was found in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, Davie, Florida. This finding identified oral liquid docusate sodium manufactured by PharmaTech as the likely source of the recent multistate B. cepacia outbreak. The B. cepacia bacteria was detected in the water system used to manufacture the liquid docusate sodium . These products were manufactured by PharmaTech and distributed and labeled by six firms: Rugby, Major, Bayshore, Metron, Centurion, and Virtus. PharmaTech Docusate Burkholderia Cepacia Outbreak Details On August 10, 2016, the U.S. Center for Disease Control and Prevention (CDC) announced that it had confirmed 58 B. cepacia outbreak cases from 8 states. PharmaTech Docusate Lawsuit Help The Weinberg Law Firm is currently assisting those who have suffered Burkholderia cepacia infections linked to Read More

August 15, 2016: FDA Provides Update On Burkholderia Cepacia Outbreak – Laxachem Organics Import Alert

Laxachem Organics Import Alert Announcement – The U.S. Food and Drug Administration (FDA) has placed Laxachem Organics Pvt. Ltd., Ahmednagar, Maharashtra, India, on import alert as of August 11, 2016, for refusing to allow FDA investigators to inspect the company’s facility. According to the announcement, the import alert stops all Laxachem pharmaceutical products from entering the United States legally. Laxachem will remain on import alert until it has been fully inspected by FDA and found to meet U.S. standards. Laxachem Organics Import Alert Information The FDA stated that “Laxachem Organics manufactures active pharmaceutical ingredient (API) for repackagers, labelers, and wholesale drug distributors, some of which sell API to manufacturing facilities in the United States. According to Laxachem’s website, one of the drugs Laxachem manufactures is Docusate Sodium USP.” The agency cautioned that “Companies that received API from Laxachem should not Read More

July 26, 2016: FDA Expands Boxed Warning to Address Painful Levaquin Reactions

Painful Levaquin Reactions In order to address the disabling and potentially permanent side effects of quinolone medications such as Levaquin, The U.S. Food and Drug Administration (FDA) approved changes to the Boxed Warning, the FDA’s strongest warning. This warning serves to inform doctors and patients of the risk of damage to tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. OBTAIN A FREE LEVAQUIN LAWSUIT EVALUATION Attorney Eric Weinberg has represented thousands of individuals injured by dangerous, defective, or mislabeled medications, including for example, Vioxx, Pradaxa, Baycol, Yaz, contaminated Blood Clotting Factors, and Ortho Evra. We have obtained over $800 million on behalf of the firm’s personal injury clients. For a free and non-obligatory defective drug lawsuit evaluation, please contact us toll free at 1-877-934-6274 or fill out our Free Lawsuit Case Evaluation Read More

July 17, 2016: FDA Alerts Healthcare Professionals Of Diocto Recall

Diocto Recall News In a Safety Alert to healthcare professionals, the U.S. Food and Drug Administration (FDA) announced that PharmaTech LLC, Davie, Florida, is recalling all non-expired lots of Diocto Liquid, a docusate sodium solution, distributed by Rugby Laboratories, Livonia, Michigan. The FDA confirmed that the recalled product is contaminated with Burkholderia cepacia, a type of bacteria linked to a multi-state outbreak. The FDA reported that is has received several adverse event reports of B. cepacia infections in patients. Liquid docusate sodium products, manufactured by companies other than PharmaTech, have also been identified in reports to the FDA. FDA and the U.S. Centers for Disease Control and Prevention (CDC) are working to identify other potentially B. cepacia contaminated liquid docusate sodium products. Diocto Recall Information According to the FDA Safety Alert, PharmaTech manufactures the oral liquid docusate sodium, which is Read More

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