In a warning issued Tuesday to GlaxoSmithKline, the U.S. Food and Drug Administration claimed that the British drug maker failed to disclose to U.S. regulators all of the post-approval data on its diabetes drug, Avandia®.
A personal injury lawsuit was recently filed in New Jersey against Baxter Healthcare Corp. claiming that the plaintiff nearly died after receiving an injection of an allegedly defective batch of the anticoagulant drug heparin.
The U.S. and Chinese governments have joined forces to determine why some patients who were given the drug heparin suffered severe adverse reactions, including nausea, breathing difficulties, and death.
Two new studies have shown that heart surgery patients who were given the anti-bleeding drug Trasylol were more likely to die than patients given other medications or none at all.
The United States Supreme Court on Monday began hearing arguments in one of two cases that may determine whether pharmaceutical companies can be sued for injuries caused by their drugs.
An Oklahoma man has filed a lawsuit alleging that the diabetes drug Avandia caused him to suffer a myocardial ischemic event.
The FDA announced today that additional warning information will appear on labels for Ortho Evra, a contraceptive patch made by Johnson & Johnson that has been associated with a high risk of blood clots.
A Connecticut woman has filed a lawsuit against Merck and Co. Inc., one of the largest U.S. drug manufacturers. She claims that she developed severe health problems from taking Fosamax, the company's popular osteoporosis medication.
A British study released last month indicates that the acne drug Roaccutane may lead to an increased risk of depression and even suicidal behavior.
Angela and Rolf Hazlehurst recently testified against the Secretary of Health and Human Services, claiming that vaccinations received during his first year caused their son, Yates, to develop autism.
On Monday, a federal judge ruled to exclude certain experts from testifying on behalf of plaintiffs against the maker of the arthritis drug Celebrex.
OxyContin victims and their families gave emotional testimony before a federal judge in the high profile case of three Purdue Pharma executives who pleaded guilty to downplaying OxyContin's risk of abuse and addiction.
A federal judge Friday ordered the maker of OxyContin and three of the company's executives to pay $634.5 million for making false statements about OxyContin's potential for abuse.
The FDA has approved a higher dosage of Fosamax Plus D, a drug designed to increase bone density in postmenopausal woman.
On May 10 three current and former executives of Purdue Pharma L.P., the company that manufactures the prescription pain killer OxyContin, pleaded guilty to intentionally misleading doctors about the risks associated with OxyContin use.
Already beset by over 27,000 Vioxx cases, the pharmaceutical giant sees lawsuits over osteoporosis drug Fosamax looming on the horizon.
A Philadelphia jury has ruled in favor of an Arkansas couple who filed a lawsuit against the manufacturer of the hormone replacement drug Prempro. The company will be forced to pay $1.5 million in compensatory damages.
A recent study suggests that Oxycontin, Vicodin, and other narcotic pain medications may not provide long-term pain relief for patients suffering from chronic back pain.
Ken Suggs, a lawyer representing Jenny Nelson, a woman who was diagnosed with breast cancer in 2001, argued that Wyeth, the manufacturer of the drug Prempro, downplayed the risk of breast cancer.
The FDA and Perrigo Co. announced the recall of 11 million bottles of acetaminophen due to possible metal fragments in the pills. The product is sold by Wal-Mart, Safeway, CVS, and over 100 other retailers.
A mistrial has been declared in the second of several thousand lawsuits against drugmaker Wyeth regarding the supposed risks of the hormone replacement therapy Prempro.
The New York federal appeals court has reinstated a lawsuit against Pfizer that was dismissed last year by a lower court judge. The suit blames Pfizer's drug Rezulin for causing liver damage.
Some medications intended to treat osteoporosis, including the popular drug Fosamax, have recently been found to increase the risk of jawbone death, also called osteonecrosis.
According to researchers at the Boston Collaborative Drug Surveillance Program, a link has been discovered between the anti-inflammatory medication diclofenac and an increased risk of heart attacks.
A new study published in the medical journal Neuropsychopharmacology reveals that the popular acne drug may have a biological link to an increase in depressed behavior among users.
A jury has found in favor of drugmaker Wyeth in the first lawsuit over the popular hormone therapy medication Prempro. The plaintiff had blamed the drug for her breast cancer.
As a result of two new studies, the FDA has updated labeling information on Ortho Evra to warn patients of the risk of blood clots as a result of using the medication.
At least 500 patients and their families are suing medical giant Johnson & Johnson, claiming that the popular Ortho Evra birth control patch caused blood clots, heart disease, and death.
After St. Petersburg, Florida, resident Jason Fulford died as a result of overdosing on a number of painkillers and anti-anxiety medications, an investigation has led back to the physician’s assistant who gave him the drugs.
Citing insufficient evidence, a US District Court judge has dismissed nearly 30 lawsuits alleging that the diabetes drug Rezulin caused liver damage.
In response to a request by the FDA, drugmaker GlaxoSmithKline will add new warnings to the label of the ADHD drug Dexedrine, cautioning of the increased risk of heart problems among users.
A new study published in the August Archives of Dermatology shows that Accutane may cause more patients to develop high cholesterol, elevated liver enzyme levels, and high triglyceride numbers than stated on the drug’s packaging.
In a report published in the July edition of the American Journal of Gastroenterology, researchers say they have found a direct link between the popular acne drug Accutane and inflammatory bowl disease, a connection only suspected until now.
A Philadelphia couple whose one-year-old son died after being given a dose of Infants’ Tylenol was awarded $5 million in a wrongful death lawsuit against the drug’s maker.
Linda Reeves, 67, is the first plaintiff in a long line of lawsuits against Wyeth, the company responsible for making Prempro.
Patients and doctors are warned that combining the use of migraine drugs called triptans with SSRI antidepressants can cause a life-threatening condition called serotonin syndrome.
Clozaril (clozapine), one of the most effective antipsychotic medications available, has been shown to drastically increase the chances of patients developing diabetes, heart disease, and other health problems.
A new study authored by scientists from the FDA shows the first hard evidence of some pituitary tumors being caused by antipsychotic medications.
Ketek, a powerful antibiotic used to treat medicine-resistant strains of bacteria, has been shown to increase the risk of liver damage among patients who take it.
A recent report shows a sharp decrease in recent FDA enforcement of drug safety measures, leading many to believe that the government agency is allowing potentially dangerous drugs to remain on the market.
The FDA has issued a warning that consumers should not use the Triaminic Vapor Patch due to the possibility that the patch and its medication could be ingested by small children during use.
Two former users of the cholesterol medication Lipitor are suing drugmaker Pfizer because of the permanent health effects they suffered due to taking the medication.
According to a large recent study in Tennessee, ACE inhibitors, a pressure-lowering medication, were recently found to increase the risk of birth defects when used by pregnant women.
Previously only thought to negatively affect women in the later stages of pregnancy, certain blood pressure medications have now been linked to health problems in the first trimester as well.
After initially pulling it from the market in February of 2005, the FDA has decided to once more allow sales of multiple sclerosis medication Tysabri under strict distribution rules.
A new study shows that several common painkillers have the potential to cause an increased risk of stroke and heart attack, similar to the negative side effects of cox-2 inhibitor drugs such as Vioxx and Bextra.
A recent letter from the FDA to drugmaker Wyeth lists numerous safety violations att he manufacturing plant in Puerto Rico that have the potential to cause drug contamination and other problems.
In the first study of its kind, the U.S. Centers for Disease Control and Prevention has estimated that more than 3,000 Americans seek emergency medical treatment for problems caused by attention deficit disorder drugs.
The latest lawsuits, which allege that the popular birth control patch caused one woman's death and another's serious illness, follow a recent FDA warning that the drug is linked to blood clots, stroke, and death.
The hearing is the latest development in the history of the controversial so-called "abortion pill." Both supporters and critics are hoping to influence the agency’s decision on whether to continue the sale of RU-486.
A study has shown that the regular use of antipsychotic medication by children and adolescents has increased dramatically over the last four years. Some experts are concerned that the long-term effects could be detrimental.
WASHINGTON - In the midst of several of the nation's largest pharmaceutical lawsuits, the FDA has been slow to detect safety problems in drugs already on the market and in responding to potential dangers, a federal study concludes.
HONOLULU -- The state filed a lawsuit against 44 drug companies on Thursday, accusing them of price gouging and setting inflated wholesale prices on prescription drugs.
Wyeth, manufacturer of Prempro, is urging the FDA to curb the availability of popular custom-blended hormone mixes, saying that they are unregulated and dangerous.
Thousands of women are alleging that the menopause drug gave them breast cancer. The first of thousands of cases against drug maker Wyeth goes to trial this summer.
Health Canada is reportedly to start probing the cause of heart attacks and strokes that have occurred over the last two decades in patients taking Accutane, a potent and controversial acne drug.
FORT MYERS, Fla. - Merck & Co. is facing another litigious nightmare and may need to hire additional attorneys to challenge a new lawsuit alleging the drug company was negligent in its handling of the osteoporosis drug Fosamax.
Consumer group Public Citizen alleges that Xenical, a prescription weight loss drug recently approved for over-the-counter use, has been connected with colon and breast cancer and should be banned from the marketplace.
A New York man has filed a suit in Federal District Court in Manhattan against Bausch & Lomb, the makers of ReNu with MoistureLoc, a contact lens solution.
The U.S. Food and Drug Administration (FDA) has been petitioned to remove the prescription diet drug Xenical (orlistat) from the market. Public Citizen, a consumer watchdog group, filed the petition.
The drug, Tysabri, was withdrawn a year ago after it was found to cause a lethal brain disease. An FDA advisory panel will allow patients and doctors to weigh the risk of taking it.
ATLANTIC CITY, New Jersey - Merck & Co. finished up its defense in the latest of a string of Vioxx product liability trials with expert testimony from a psychiatrist.
A New Jersey Teamsters union has filed a federal lawsuit against Pfizer Inc. alleging that the pharmaceutical company marketed the cholesterol drug Lipitor to people with low risk of heart attacks.
After receiving reports of skin cancer and lymphoma among patients taking certain eczema medications, the FDA has ordered a "black-box" warning to be placed on two drugs.
Ambien, currently the most often-prescribed sleep aid medication, is the target of reports from patients who say the drug caused them to behave erratically and dangerously at night.
According to recent research, patients with chronic kidney failure may be able to blame their conditions on certain medications used to cleanse the bowels prior to colonoscopies.
Medical industry watchdogs are calling on the FDA to launch an investigation into the safety of medicated patches that have been shown to malfunction when body temperature rises.
The advocacy group Public Citizen recently petitioned the Food and Drug Administration in an effort to begin a measured phase-out of propoxyphene, which includes the brands Darvon and Darvocet.
After finding a link between Adderall and increased heart attack risk, an FDA advisory committee will be taking a closer look at the safety and efficacy of such medications when given to children with ADHD.
Accused of prescribing large quantities of Oxycontin and causing the deaths of five patients in the last three years, Dr. Thomas G. Merrill of Apalachiola, Fla. was found guilty on nearly all counts against him.
Trasylol (aprotinin), a medication designed to reduce bleeding during heart surgery, has been linked in studies to an increase in serious health problems and death.
Both the Elidel cream and the Protopic ointment will receive the strong cautionary labeling after reports of nearly 80 cases of cancer, including lymphoma and skin cancer, in patients taking the drugs.
Available via the Internet and marketed under such names as Emagrece Sim and the Brazilian Diet Pill, the pills contain habit-forming ingredients similar to those in Prozac and Librium.
Spurred on by FDA concerns about the safety of such ADHD drugs as Adderall, an advisory committee will examine the risk of heart problems caused by the medications.
Patients with bleeding disorders who are taking WinRho SDF have been cautioned about the risk of loss of red blood cells.
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