Tagged Articles

Merck 97 articles

New diabetes drug tested as an add-on in triple therapy

diabetes_illus250x03

Merck and Pfizer are teaming up on a new type 2 diabetes treatment and if clinical trials continue to show promise, they hope to apply for Food and Drug Administration (FDA) approval by the end of the year. The experimental drug, ertugliflozin is in a class of type 2 diabetes drugs called sodium glucose cotransporter 2 (SGLT2) inhibitors, which also includes the brand names Invokana, Invokamet and Jardiance. SGLT2 inhibitors work to lower blood sugar levels by blocking the reabsorption of glucose in the kidneys, allowing more sugar to be excreted through the urine. Ertugliflozin improved glycemic control in type ... Read More

Merck gives up on experimental osteoporosis drug due to safety concerns

heartbeat

Merck’s experimental osteoporosis drug odanacatib showed that it was effective at preventing bone fractures, but put users at risk of atrial fibrillation and stroke. As a result, Merck said that the risks of the drug outweighed the benefits and thus they were officially giving up on the development of odanacatib. Atrial fibrillation is a quivering or irregular heartbeat that can lead to blood clots, strokes, heart failure, and other heart-related conditions. Two years ago, Merck announced it was delaying a filing with the Food and Drug Administration (FDA) after Phase III results raised cardiovascular safety concerns. The news was a blow ... Read More

FDA warns of dosing errors with antifungal drug Noxafil

Noxafil anti fungal

Reports of hospitalizations and a patient death related to dosing errors with the antifungal medication Noxafil (posaconazole) have prompted the Food and Drug Administration (FDA) to issue a Drug Safety Communication cautioning health care providers that there has been confusion with differences in dosing regimens between two oral formulations of the drug Noxafil. Noxafil is used to treat or prevent fungal infections such as Aspergillus and Candida, especially in people with weakened immune systems such as those undergoing chemotherapy, stem cell transplantation and those with HIV infections. It is also used to treat a fungal infection called thrush caused by ... Read More

Merck accused of FLSA violations; class action filed by plant employees

money

Merck & Co. Inc., the pharmaceutical giant responsible for drugs like Vioxx and Gardasil, is now the target of a proposed class and Fair Labor Standards Act (FLSA) collective action filed in New Jersey federal court. The suit claims the Merck employees were forced to labor at least 45 minutes prior to their normal shift daily without compensation. The 26 employees worked full time in the Rahway, N.J., “pilot plant” as research chemical operators (RCOs), some having been employed as early as 1995. Upon bringing the unpaid compensation issue up to the company, the complaint alleges Merck threatened their jobs and ... Read More

Four Dangerous Diabetes Drugs

diabetes_illus250x03

Type 2 diabetes is a growing epidemic around the world with an estimated one in 10 adults predicted to be suffering from the disease by 2030, according to the International Diabetes Foundation. Diabetes increases the risk for serious health complications including heart disease, kidney disease, cancer, blindness, dementia and amputations from neuropathy. Many diabetics require medication to help control blood sugar levels. There are dozens of diabetes treatments on the market and more being developed. But these drugs come at a risk. Here are five type 2 diabetes drugs that carry dangerous side effects: Invokana/Invokamet – Known chemically as canagliflozin, Invokana ... Read More

Whistleblowers accuse Merck of withholding, distorting mumps vaccine data

whistleblower-5

Two former Merck virologists who filed a whistleblower lawsuit against the pharmaceutical company alleging it falsified data so the U.S. government would buy its mumps vaccine are now also accusing the drug giant of dodging questions about the vaccine’s effectiveness. In a June 1 letter, Stephen A. Krahling and Joan A. Wlochowski, who filed the whistleblower suit against Merck & Co. under the federal False Claims Act, asked Pennsylvania federal judge Lynne A. Sitarski to force Merck to answer questions about the effectiveness of its mumps vaccine, saying the company is “hiding behind a facade of confusion and obfuscation” on ... Read More

Novartis settles lawsuit claiming osteoporosis drug caused jawbone decay

zometa

A lawsuit against the makers of the osteoporosis drug Zometa claiming the medication caused serious jawbone decay has been settled, just as a state appeals court was scheduled to rule whether to affirm or reverse the no-cause verdict won previously by Novartis Pharmaceuticals Corp., against the plaintiff. The terms of the agreement will not be disclosed. The lawsuit, filed by plaintiff Beverly Meng, was only the second to go to trial in New Jersey. Another 119 lawsuits in New Jersey name Novartis’ Zometa or the company’s other bone loss drug Aredia claiming jawbone injury are yet to be heard. The ... Read More

Lawsuits claim type 2 diabetes drugs caused pancreatic cancer

januvia - sitagliptin

Ann Falcone of Staten Island, NY is suing two different drug companies alleging their type 2 diabetes treatments caused her to develop pancreatic cancer. Falcone claims she began taking Januvia (sitagliptin) in July 2009 to help control her blood sugar levels. Januvia is a oral antihyperglycemic drug known as a dipeptiidyl peptidase-4, or DPP-4, inhibitor. In May 2011, her doctor also prescribed Victoza (liraglutide), an injectable long-acting glucagon-like peptide-1 agonist, or GLP-1 agonist. Both drugs are in a class of type 2 diabetes medications known as incretin mimetics. But a year after starting Victoza, Falcone was diagnosed with pancreatic cancer. It ... Read More

Merck company Organon to pay several states $31 million to settle Medicaid fraud allegations

whistleblower

Following an investigation into possible Medicaid fraud, Drug maker Organon USA Inc., a subsidiary of pharmaceutical giant Merck, has agreed to pay $31 million to settle allegations by several U.S. states that it overcharged their Medicaid programs for the anti-depressant Remeron and Remeron SolTab. The states claimed that Organon encouraged pharmacies to offer Remeron to their nursing home clients by providing the drug at a discount, which gave Organon a competitive edge against other drug manufacturers. Organon then reported the drug’s full cost when it sought reimbursements from the Medicaid programs in multiple states, the plaintiffs alleged. Washington D.C. and ... Read More

Merck’s once-weekly diabetes drug as effective as Januvia

januvia - sitagliptin

Merck’s new, once-weekly experimental type 2 diabetes treatment was found in recent clinical trials to have a similar safety and efficacy profile compared to Merck’s sitagliptin, marketed under the brand name Januvia. The study involving the new omarigliptin randomly assigned participants with type 2 diabetes into one of three groups – once-weekly omarigliptin 25 mg; once-daily Januvia 50 mg; or placebo. A mixed-meal tolerance test was performed the day before the study drugs were administered and again at 24 weeks, 1 day after the last dose of Januvia, or 7 days after the last dose of omargliptin. Researchers found that ... Read More