Category Archives: Drug Side Effects

Blame it on Pheidippides. Legend says that sometime around 490 B.C., the Greek herald ran over two dozen miles from the town of Marathon to Athens to announce his citys victory over Persia in battle. He then dropped dead. Somehow, this story has inspired people ever since. Some 2,500 years after the jog that launched a million shin splints, marathoning has gone from heroic journey to commonplace event. There are almost 500 marathons each year in the U.S. alone. In 2011, well over half a million people finished marathons and those numbers keep multiplying, just like all those 26.2 stickers on the bumpers of Priuses. Suddenly, it seems everybodys getting the urge to go the distance. Including, to my great surprise, me. Id certainly never envisioned myself in these Asics. Though Ive been running almost daily for years, until recently Ive rarely gone beyond five miles at a time and never felt the urge to. In fact, for the last several months, as Ive endured the physical and emotional butt-kicking of a phase 1 clinical trial for cancer treatment, most days its been a struggle just to get out of bed, let alone plod laps around the park. Yet as … Continue reading →

The European Medicines Agency is investigating "deficiencies" in the way drug maker Roche reported possible side effects in patients in the U.S., though it said there was no evidence patients are at risk. European authorities spotted the problems during a routine inspection of Roche by British regulators in May. They noticed about 80,000 reports of possible side effects for medicines sold in the U.S. had not been analyzed to see if they were truly suspected adverse effects that needed to be reported. The reports were collected in a patient program that helps people deal with health insurance issues in the U.S., like reimbursement for medicines. Dozens of drugs were involved, including many cancer drugs. In the reports of possible side effects, there were more than 15,000 deaths. The European Medicines Agency said it was unclear whether those deaths were linked to any Roche medicines. "The scale of it sounds big, but what is not known is how many of these deaths have already been reported in another way," said Monika Benstetter, an EMA spokeswoman. "We need to get to the bottom of this." Drug agencies regularly track side effects of drugs on the market since rare adverse events might not … Continue reading →

Home : Health : Roche criticized for not adequately reporting side effects The Associated Press Date: Friday Jun. 22, 2012 9:24 AM ET LONDON The European Medicines Agency is investigating "deficiencies" in the way drug maker Roche reported possible side effects in patients in the U.S., though it said there was no evidence patients are at risk. European authorities spotted the problems during a routine inspection of Roche by British regulators in May. They noticed about 80,000 reports of possible side effects for medicines sold in the U.S. had not been analyzed to see if they were truly suspected adverse effects that needed to be reported. The reports were collected in a patient program that helps people deal with health insurance issues in the U.S., like reimbursement for medicines. Dozens of drugs were involved, including many cancer drugs. In the reports of possible side effects, there were more than 15,000 deaths. The European Medicines Agency said it was unclear whether those deaths were linked to any Roche medicines. "The scale of it sounds big, but what is not known is how many of these deaths have already been reported in another way," said Monika Bernstetter, an EMA spokeswoman. "We need … Continue reading →

Swiss pharmaceutical giant Roche is under investigation over a failure to properly report adverse drug side-effects, the European Medicines Agency (EMA) says. Inspectors at the Basel-based company's British site in Welwyn found deficiencies related to Roche's global process of detecting and reporting the adverse effects of medicines. At the time of the inspection, 80,000 reports for medicines marketed by Roche in the US had been collected through a Roche-sponsored patient support program, but had not been evaluated to determine whether they should be reported to the EU authorities as suspected adverse reactions. 'These included 15,161 reports of death of patients and it is not known whether the deaths were due to natural progression of the disease or had a causal link to the medicine,' the EMA said in the statement on Thursday. 'There is, at present, no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or healthcare professionals to take any action,' added the EMA. A Roche spokesman said the company acknowledges it did not fully comply with regulations and appreciates the concerns that can be caused by this issue for people using its products. 'Roche is committed … Continue reading →

The European Medicines Agency said on Thursday it was investigating Swiss group Roche Holding AG after a routine inspection found it had failed to properly assess 80,000 cases of possible adverse drug reactions. The issue relates to medicines from across the Roche product range that were part of a financial reimbursement system in the United States. Roche is the world's largest maker of cancer medicines and it also produces drugs for viral infections, central nervous system disorders and inflammatory diseases. "There is at present no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or healthcare professionals to take any action," the agency said in a statement. The move was triggered by a routine check by British regulators that found Roche had not properly evaluated around 80,000 reports linked to a company-sponsored patient support program dating back to 1997 to see if they should be reported as suspected adverse reactions. These included 15,161 deaths, which may have been due to natural disease progression but may have been connected to the drugs. More recent information from the company indicated fewer reports, but this needed to be verified, the agency said. … Continue reading →

LONDON The European Medicines Agency is investigating "deficiencies" in the way drug maker Roche reported possible side effects in patients in the U.S., though it said there was no evidence patients are at risk. European authorities spotted the problems during a routine inspection of Roche by British regulators in May. They noticed about 80,000 reports of possible side effects for medicines sold in the U.S. had not been analyzed to see if they were truly suspected adverse effects that needed to be reported. The reports were collected in a patient program that helps people deal with health insurance issues in the U.S., like reimbursement for medicines. Dozens of drugs were involved, including many cancer drugs. In the reports of possible side effects, there were more than 15,000 deaths. The European Medicines Agency said it was unclear whether those deaths were linked to any Roche medicines. "The scale of it sounds big, but what is not known is how many of these deaths have already been reported in another way," said Monika Benstetter, an EMA spokeswoman. "We need to get to the bottom of this." Drug agencies regularly track side effects of drugs on the market since rare adverse events might … Continue reading →

LONDON (AP) -- The European Medicines Agency is investigating "deficiencies" in the way drug maker Roche reported possible side effects in patients in the U.S., though it said there was no evidence patients are at risk. European authorities spotted the problems during a routine inspection of Roche by British regulators in May. They noticed about 80,000 reports of possible side effects for medicines sold in the U.S. had not been analyzed to see if they were truly suspected adverse effects that needed to be reported. The reports were collected in a patient program that helps people deal with health insurance issues in the U.S., like reimbursement for medicines. Dozens of drugs were involved, including many cancer drugs. In the reports of possible side effects, there were more than 15,000 deaths. The European Medicines Agency said it was unclear whether those deaths were linked to any Roche medicines. "The scale of it sounds big, but what is not known is how many of these deaths have already been reported in another way," said Monika Bernstetter, an EMA spokeswoman. "We need to get to the bottom of this." Drug agencies regularly track side effects of drugs on the market since rare adverse … Continue reading →

A drug used for treating high blood pressure has been linked with a number of severe gastrointestinal side effects, according to a report from the Mayo Clinic. Between 2008 and 2011, 22 patients taking the drug olmesartan, sold under the brand name Benicar, suffered symptoms similar to celiac disease, including chronic diarrhea, vomiting, intestinal inflammation and weight loss. Fourteen of the patients had to be hospitalized. Doctors tried putting the patients on a gluten-free diet, the typical solution for treating celiac disease, but to no avail. When patients stopped taking olmesartan, their symptoms improved dramatically. Dr. Joseph Murray, the Mayo Clinic gastroenterologist who treated the patients, said the problem is most likely very rare. "The message to people taking this drug is that they should not stop their medications," Murray said in a press conference. "If they're having GI problems, they should talk with their doctors." Olmesartan is an angiotensin II receptor blocker, or ARB, a popular class of drugs used to treat high blood pressure. According to the U.S. Food and Drug Administration, pharmacies dispensed the drug to 1.2 million Americans in 2010. About 68 million Americans have high blood pressure, according to the U.S. Centers for Disease Control … Continue reading →

Public release date: 20-Jun-2012 [ | E-mail | Share ] Contact: Ruthann Richter richter1@stanford.edu 650-725-8047 Stanford University Medical Center STANFORD, Calif. Genetics play a significant role in determining which patients will suffer the most from the disturbing side effects of opiates, commonly prescribed painkillers for severe to moderate pain, according to a new Stanford University School of Medicine study, which pinpoints nausea, slowed breathing and potential for addiction as heritable traits. "One of the most hated side effects of these opiates, nausea, is strongly inherited," said Martin Angst, MD, professor of anesthesia and one of two principal investigators for the new study, which explores individual variations in the response to opiate use. The study will be published online June 20 in Anesthesiology. Genetics also play a likely role in determining which patients will suffer from itchiness and sedation associated with the use of these powerful medications, which include morphine, methadone and oxycodone. "The study is a significant step forward in efforts to understand the basis of individual variability in response to opioids and to eventually personalize opioid treatment plans for patients," said Angst, director of the Stanford Human Pain Research Laboratory. "Our findings strongly encourage the use of downstream molecular … Continue reading →

Attorney (866) 735-1102 Ext 305 The hair growth drug, Propecia, was first approved in 1997 by the Food and Drug Administration (FDA). When the drug was first introduced into the market, a number of researchers and doctors expressed concerns about Propecias severe side effects. According to John Peige of the Baltimore Courts Examiner, one of these doctors who expressed serious concerns about Propecia was well-known hair-restoration expert L. Lee Bosley. Dr. Bosley publicly denounced Propecia, saying that the drug had serious side effects and health concerns. Dr. Bosley is quoted in Business Wire headlined, Supposed Miracle Baldness Cure Creates Serious Health Concerns Among Hair Restoration Professionals, saying: "The FDA has just approved a drug that has the capability to impair male sexual performance, creating the inability to achieve an erection [and] decreases libido... The potential side effects, especially the long-term side effects of the drug, should be the overriding concerns to both the users and the manufacturer." It was only a few years later when Dr. Bosley allowed his doctors to recommend Propecia to patients. Even while the Bosley Medical group knew of the dangerous side effects Propecia had, they did not warn patients who were prescribed this drug. The … Continue reading →