Industry News

Pharmaceutical Legislation Changes In Europe - EMA and Member States Prepare

Feb, 3 (Medical News Today) -- Preparations are underway at the European Medicines Agency together with European Member States and the European Commission, for the introduction of the new pharmacovigilance legislation in July this year. The new legislation will represent the biggest change to the legal framework since The Agency was founded in 1995. The Agency is finalizing their preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), which is scheduled for 19 July 2012.

FDA warns docs on wart remover and eye salve mix-ups

Dec. 28 (Reuters) -- The U.S. Food and Drug Administration warned healthcare workers on Wednesday to be careful when using two similarly named but very different drugs, saying a recent mix-up involving the two medications had injured a patient. The agency said the incident occurred when a pharmacist confused Durasal, a wart remover not approved by the FDA, with Durezol, an FDA-approved steroidal eyedrop used to treat inflammation and pain following eye surgery.

Epidurals Linked to Paralysis Seen With $300 Billion Pain Market

Dec. 28 (Boomberg) -- Valinda Parrish talks to her 60- year-old husband like a doting mother speaks to a child. “I am going to go outside for a little bit,” she tells him. “Use your horn if you need me.” Rollie Parrish, nearly blind and in a wheelchair, toots the air horn he keeps on his lap if he wants something to eat or has to go to the bathroom. Four years ago, the Vietnam veteran had just spent a weekend deer hunting when he went to a hospital near his home in Nederland, Texas, for a shot of steroids to his neck to ease chronic pain. He suffered a stroke during the procedure, according to a lawsuit that was settled out of court. “He knows what happened to him, and he is angry,” his wife of 29 years said in an interview.

Risk for Thrombotic Events Prompts FDA to Issue REMS for Rivaroxaban

Dec. 21 (AAFP) -- The FDA has called for a risk evaluation and mitigation strategy, or REMS, for the oral anticoagulant drug rivaroxaban, which is marketed as Xarelto. In a letter to health care professionals (2-page PDF; About PDFs) from Janssen Pharmaceuticals Inc., which markets Xarelto in the United States, Paul Chang, M.D., vice president of medical affairs, said that the FDA asked the company to produce both a patient medication guide and a communication plan to ensure prescribers are aware of important safety information regarding rivaroxaban to "ensure that the benefits of the drug outweigh the potential risks in patients with nonvalvular atrial fibrillation."

FDA Crackdown on Viagra-Like Supplements

Dec. 15 (Bloomberg) -- Rock Hard Weekend, a blue-and-white pill touted in ads as a source of “all-natural male enhancement,” had a secret ingredient, U.S. regulators say: A chemical almost identical to Pfizer Inc.’s Viagra. The discovery came during a Food and Drug Administration inspection that’s part of an expanding crackdown by the agency on the $28 billion supplement industry. Shannon Pettypiece reports on Bloomberg Television's "InsideTrack." (Source: Bloomberg)

Nasty Side Effects Make Breast Cancer Patients Quit Drugs Early

Dec. 9 (ABC News) -- More than one third of women taking a certain class of breast cancer drugs are so bothered by side effects that they stop taking the pills before their treatment is complete, according to a new study. Doctors typically prescribe a five-year course of the drugs, called aromatase inhibitors, for post-menopausal women after breast cancer surgery, chemotherapy or radiation treatment. The drugs are widely perceived as powerful tools to prevent breast cancer from returning.

Pfizer Settles Prempro Case After Losing $72.6 Million Verdict

Dec. 9 (Bloomberg) -- Pfizer Inc. (PFE), the world’s largest drugmaker, agreed to settle claims that its menopause drugs caused cancer in three women who won a $72.6 million jury award earlier this week, a lawyer said. The New York-based company agreed to resolve claims by Susan Elfont, Bernadette Kalenkoski and Judy Mulderig that hormone-replacement drugs made by two Pfizer units caused their breast cancer, Ted Meadows, a lawyer for the women, said in an interview yesterday. A Philadelphia jury awarded the three women $72.6 million in compensatory damages on Dec. 6.

Gynecologists Unfazed as Birth Control Clot Concerns Resurface at FDA

Dec. 8 (Bloomberg) -- Undeterred by evidence that newer birth control pills such as Bayer AG’s Yasmin may carry more risk of dangerous blood clots, top doctors say they still plan to prescribe them. Yasmin, introduced in 2001, and other contraceptives containing the hormone drospirenone have been the focus of lawsuits and studies that differ in conclusions about the risk. Advisers to the Food and Drug Administration meeting today to review the science, voted that the drugs’ prescribing label be changed to better reflect the danger of getting a blood clot. The panel also said the pills’ benefits outweigh the risks.

FDA Drops Safety Program For Potentially Risky Drugs

Dec. 7 (Medical Daily) -- The U.S. Food and Drug Administration has stopped applying a safety program for two drugs - Nplate and Promacta – because the program's data was not useful for determining and distinguishing between the effects of the drugs and underlying medical conditions in patients using them. The agency has monitored the safety of Nplate and Promacta since 2008 using the Risk Evaluation and Management Strategy (REMS). At the time of approval, experience with both drugs was limited, so for safety reasons, the FDA decided to monitor the drug through the agency’s REMS program. After an evaluation, the agency concluded that the REMS program was inadequate.

Alexza Inhaled Antipsychotic May Pose Fatal Lung Risks, FDA Review Finds

Dec. 7 (Bloomberg) -- Alexza Pharmaceuticals Inc. (ALXA)’s inhaled antipsychotic drug may put some patients at risk for respiratory failure, according to U.S. regulators considering whether to approve the treatment for sale. While Adasuve is effective as a fast-acting treatment for agitation among patients with schizophrenia and bipolar disorder, it can cause bronchial spasms that may be fatal in people with conditions such as asthma, Food and Drug Administration staff said today in a report. Outside advisers to the agency plan to meet Dec. 12 to evaluate the findings.

Bayer Withheld Yasmin Data From U.S., Former Agency Chief Tells Court

Dec. 6 (Bloomberg) -- A Bayer AG unit withheld from U.S. regulators findings by company researchers of increased reports of blood clots in users of its Yasmin birth-control pills, the former head of the Food and Drug Administration said. David Kessler, the former FDA commissioner, in a document unsealed yesterday in federal court in Illinois, said Bayer didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or clots, in a 2004 review of Yasmin’s safety provided to the agency.

With Par Pharmaceutical Suit, Courts Should Put an End to FDA's Lawless Behavior on Off-Label Speech

Nov. 28 (Forbes) -- The Food and Drug Administration has been largely successful in avoiding judicial review of claims that its regulation of drug promotion activities runs afoul of First Amendment constraints. But FDA may well be unable to avoid a merits-based review of First Amendment claims raised in a lawsuit recently filed by Par Pharmaceutical, Inc. Par complains that FDA is chilling its speech rights by threatening to crack down on truthful speech about on-label uses for its FDA-approved products.

Four Drugs Cause Most Hospitalizations in Older Adults

Nov. 23 (The New York Times) -- Blood thinners and diabetes drugs cause most emergency hospital visits for drug reactions among people over 65 in the United States, a new study shows. Just four medications or medication groups — used alone or together — were responsible for two-thirds of emergency hospitalizations among older Americans, according to the report.

China seizes 65M counterfeit pills, some harmful

Nov. 4 (Yahoo) -- Police in China have seized more than 65 million fake pills and arrested 114 suspects during a four-month investigation into counterfeit drugs. The Ministry of Public Security said in a statement Friday that a criminal network extending over eight provinces used starch or corn powder to make fake medicines and repackaged drugs past their use-by dates.

Lipitor Rage

Nov. 2 (Slate) -- Patient 1 wanted to kill someone. Normally even-tempered, the 63-year-old man found himself awaking with an uncontrolled anger and the desire to smash things. His violent impulses started after he began taking the cholesterol-lowering statin Lipitor and they vanished within two days of quitting the drug. Patient 2 developed a short fuse after he started on Zocor*, another popular statin

New study says Chantix raises suicide risks

Nov. 2 (Reuters) -- Pfizer's smoking cessation drug Chantix carries too many risks and should only be tried when other treatments fail, researchers said on Wednesday. Chantix was eight times more likely to be linked with a reported case of suicidal behavior or depression than other nicotine replacement products, such as the nicotine patch, they said.

Baxter’s Hemophilia Drug Cuts Bleeding Risk 62%, Study Shows

Nov. 2 (Bloomberg) -- Baxter International Inc. (BAX)’s Feiba drug reduced joint and other bleeding by 62 percent for patients with a severe form of hemophilia, a study showed, offering a possible new treatment for people with few options. The company-funded trial measured the medicine’s effect on 26 patients, finding the number of times bleeding over six months of taking the therapy as a preventative measure fell to an average of five, compared with 13 times for a group that took the therapy on an in-demand basis, the researchers said in the New England Journal of Medicine today.

Studies Suggest Case for Dietary Supplements is Collapsing

Oct. 26 (Fox News) -- A succession of large-scale human studies, including two published earlier this month in leading medical journals, suggests that multivitamins and many other dietary supplements often do not have health benefits and in some cases may even cause harm.

Lilly Pulls Xigris Off Markets After Sepsis Drug Fails Study

Oct. 25 (Bloomberg) -- Eli Lilly & Co. (LLY) said it will pull its Xigris sepsis drug from all markets after the treatment failed to reduce deaths in a study. The withdrawal may cost Lilly $75 million to $95 million in the fourth quarter of 2011, or about 5 cents a share, the Indianapolis-based company said in a statement. Lilly’s 2011 adjusted earnings forecast remained at $4.30 to $4.35 a share.

Jazz Pharmaceuticals shares fall after FDA warning

Oct. 18 (Associated Press) -- Shares of Jazz Pharmaceuticals Inc. fell Tuesday after the Food and Drug Administration released a warning letter issued to the company over violations at a California plant. Company shares ended down $2.68, or 6.2 percent, to $40.34.

Clinician Letter to NEJM Sends Incyte Stock Tumbling

Oct. 16 (Proactive Investors) -- On Thursday October 13th, the New England Journal of Medicine (NEJM) published a letter from prominent leukemia specialist and Key Opinion Leader (KOL), Dr. Ayalew Tefferi critiquing the efficacy and long-term safety of Incyte Pharmaceutical’s first in class JAK inhibitor, ruxolitinib. That day, Incyte’s stock dropped 6.8% on twice the usual volume.

J&J Didn’t Warn Levaquin Riskier Than Rivals, Lawyer Argues

Oct. 13 (Bloomberg) -- A Johnson & Johnson (JNJ) unit never warned users of the Levaquin antibiotic that it posed a greater risk of tendon damage than rival medications, a lawyer for two men suing the company said today. Executives of J&J’s Ortho-McNeil-Janssen Pharmaceutical unit sought to protect sales by omitting information about Levaquin’s “comparative risk” from its warning label, Andy Alonso, a lawyer for Paul Gaffney and Robert Beare, said in closing arguments in the trial of their lawsuits against the drugmaker.

Sprycel (dasatinib): Drug Safety Communication - Risk of Pulmonary Arterial Hypertension

Oct. 12 (FDA) -- FDA notified healthcare professionals that Sprycel (dasatinib) may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). In reported cases, patients developed PAH after starting Sprycel, including after more than one year of treatment.

Breast cancer drug tied to diabetes in older women

Oct. 7 (Reuters) -- Older women taking the breast cancer drug tamoxifen may have an increased risk of developing diabetes, a new study suggests. The findings, reported in the journal Cancer, do not prove that tamoxifen directly leads to diabetes in some women. But researchers say it is plausible that in women with known risk factors for diabetes -- like obesity or family history of the disease -- tamoxifen furthers the risk somewhat. The study, of more than 14,000 breast cancer survivors age 65 and up, found that 10 percent were diagnosed with diabetes over five years.

Link between narcolepsy and flu vaccine investigated

Oct. 7 (BBC News) -- Health officials are investigating a link between narcolepsy and the Pandemrix vaccine in two people who were treated for swine flu. Northern Ireland's Chief Medical Officer has confirmed to the BBC, that Northern Ireland had become the latest country to report suspected cases of the sleeping disorder. Dr Michael McBride said the vaccine was used during the flu pandemic of 2009.

Clinical Advisory: Secondary Prevention of Small Subcortical Strokes Trial: NINDS Stops Treatment with Combination Antiplatelet Therapy (Clopidogrel plus Aspirin) Due to Higher Risk of Major Hemorrhage and Death

Oct. 6 (U.S. National Library of Medicine) -- The National Institute of Neurological Disorders and Stroke (NINDS) has stopped the combination antiplatelet intervention in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial. The SPS3 trial is a randomized, multicenter clinical trial being conducted throughout North America, Latin America and Spain, to learn about preventing a second stroke in patients who had a subcortical stroke and to learn how to prevent cognitive problems after a stroke. A subcortical stroke, also known as lacunar stroke, causes damage to small areas in the brain.

Teva Put Its Profit Ahead of Propofol Patient Safety, Jury Told

Oct. 6 (Bloomberg) -- Teva Pharmaceutical Industries Ltd. (TEVA), the world’s biggest generic-drug maker, was accused by lawyers at a Nevada trial of putting profit ahead of the safety of colonoscopy patients who got the company’s Propofol anesthetic from reused vials.

Breast cancer drug tied to diabetes in older women

Oct. 6 (Reuters) -- Older women taking the breast cancer drug tamoxifen may have an increased risk of developing diabetes, a new study suggests. The findings, reported in the journal Cancer, do not prove that tamoxifen directly leads to diabetes in some women. But researchers say it is plausible that in women with known risk factors for diabetes -- like obesity or family history of the disease -- tamoxifen furthers the risk somewhat.

Link between narcolepsy and flu vaccine investigated

Oct. 3 (BBC) -- Health officials are investigating a link between narcolepsy and the Pandemrix vaccine in two people who were treated for swine flu. Northern Ireland's Chief Medical Officer has confirmed to the BBC, that Northern Ireland had become the latest country to report suspected cases of the sleeping disorder. Dr Michael McBride said the vaccine was used during the flu pandemic of 2009. "Let's be clear - this is not the vaccine that we use today," he added.

Clarimed, AdverseEvents bring ratings for drugs and medical devices to consumers

Sept. 28 (Bloomberg) -- Two companies aim to do for the health-care industry what Morningstar Inc. does for stocks and Carfax Inc. for vehicles: provide consumers with ratings for drugs and medical devices. Clarimed LLC, a closely held Santa Clara, California-based company, takes publicly available information about side effects and negative outcomes for 125,000 medical devices such as heart stents and pacemakers and puts it on a website that’s searchable by type or disease. AdverseEvents Inc., which like Clarimed unveiled its service at this week’s Health 2.0 Conference in San Francisco, seeks to provide transparency on negative drug interactions.

China Bans Clenbuterol Tablet Production, Sale, Use

Sept. 29 (Bloomberg) -- China banned the production, sale and use of clenbuterol hydrochloride tablets in the country, according to a statement posted on the State Food and Drug Administration’s website today. The administration views the tablets as having greater risk in its use, including side effects and abuse, than its benefits, according to the statement. The tablets are mainly used for bronchial asthma treatments, the statement said. Clenbuterol has been found to be fed illegally to pigs to induce the growth of lean meat. To contact the editor responsible for this story: Bloomberg News at jliu42@bloomberg.net

FDA Still Reviewing Clot Risk for Birth Control Pills

Sept. 26 (Med Page Today) -- Four months after announcing that it was reviewing the safety of certain drospirenone-containing oral contraceptives, following reports of heightened risk for blood clots, the FDA said Monday that it still had not reached a conclusion. Data from a large FDA-funded epidemiologic study have now undergone preliminary analysis and suggest a 1.5-fold increase in venous thromboembolism (VTE) risk associated with the drospirenone-containing contraceptives, the FDA said.

French Drug Watchdog Warns Against Two Diet Pills, Echos Report

Sept. 26 (Bloomberg) -- France’s drug regulator warned against potential side effects of diet pills sold by GlaxoSmithKline Plc (GSK) and Roche Holding AG (ROG),Les Echos reported. Roche’s Xenical and Glaxo’s Alli both contain an active ingredient called orlistat which might cause rare types of hepatitis, the newspaper said. The European Medicines Agency, Europe’s drug regulator, decided to study the matter last week, according to Les Echos.

A drug in limbo, Catch-22 for FDA

Sept. 25 (The Inquirer) -- The normal tug-of-war between a pharmaceutical company and the U.S. Food and Drug Administration over approval for a drug has been turned on its side with midodrine, a medicine that helps about 100,000 patients a year avoid the potential dangers of low blood pressure. Shire Pharmaceuticals Inc., with U.S. headquarters in Wayne, no longer makes the drug, but it wants the FDA to give finalapproval of midodrine to lift a regulatory cloud. Barring that, it wants the FDA to approve Shire's plan for new trials or hold a hearing that might kill the drug.

EU regulator to review anti-obesity medicines

Sept. 22 (Reuters) -- The European Medicines Agency said it would look into anti-obesity medicines that contain orlistat, including Roche's Xenical and GlaxoSmithKline's Alli. Its move follows some rare cases of severe liver injury that could affect the drugs' benefit-risk profile. The EMA, the European Union's drug regulator, said the review would include the prescription-only medicine Xenical (orlistat 120 mg), and the lower dose over-the-counter-medicine Alli, as well as other medicines containing orlistat.

No more Primatene Mist in the U.S. after this year

Sept. 22 (CNN) -- The Food and Drug Administration is reminding doctors and patients that Primatene Mist, the only nonprescription asthma inhaler in the United States, can no longer be sold or prescribed after December 31. Asthma patients are urged to get prescriptions for alternative medications, since this treatment option runs out at the end of the year, the FDA said Thursday.

FDA cracks down on over-the-counter sex pills sold as supplements

Sept. 15 (The Palm Beach Post) -- Walk into almost any convenience store or gas station and you'll find pills that promise better sex. Some of these supplements that promise a libido boost have been pulled from shelves nationwide after their manufacturers — some based in Florida — were cited by the U.S. Food and Drug Administration. The pills were laced with ingredients found in prescription drugs or their online ads made false claims, the FDA found.

Bone Drugs Need Label Changes on Use Duration, Panel Says

By Molly Peterson - Sep 9, 2011 2:45 PM PT Bone drugs from Warner Chilcott Plc (WCRX), Roche Holding AG (ROG), Merck & Co. and Novartis AG (NOVN) need labeling changes to reduce the risk of fractures, a U.S. panel said.The FDA should call for clarifications on the length of time that osteoporosis patients should take the medicines, outside advisers to the Food and Drug Administration said today in a 17-6 vote in Adelphi, Maryland. The FDA isn’t required to follow its panels’ recommendations.

FDA Warns of New Infections With TNF Blockers

By Nancy Walsh, Staff Writer, MedPage Today Published: September 07, 2011. The Food and Drug Administration has updated the boxed warning for all tumor necrosis factor-alpha (TNFα) inhibiting drugs to reflect the risk of infection from the bacteria Legionella and Listeria. There now have been more than 100 cases of infection with these pathogens, according to the agency.

Women who take NSAIDs early in pregnancy may up miscarriage risk

By Jeannine Stein, Los Angeles Times / For the Booster Shots blog September 6, 2011, 1:11 p.m. Canadian and French researchers evaluated 4,705 miscarriage cases up to the 20th week of pregnancy among women age 15 to 45. They were matched with 47,050 controls who did not have a miscarriage at the same point in their pregnancy as corresponding women in the other group.

With Mental Health Drugs, Greater Risk Means More Marketing

Posted: 9/6/11 08:43 AM ET By Matthew Erlich and Lloyd Sederer. "Television has done much for psychiatry," Alfred Hitchcock remarked, "by spreading information about it, as well as contributing to the need for it." Hitch did not live long enough to become acquainted with the dizzying number of commercials for psychiatric medications that promise relief from suffering, performance enhancement and healthy outcomes.

Severe Allergic Reactions Draw FDA Warning on Saphris

By John Gever, Senior Editor, MedPage Today Published: September 01, 2011 The antipsychotic drug asenapine maleate (Saphris) can cause life-threatening allergic reactions, even at the first dose, the FDA said. Label information for the drug will be updated to include a section about the risk, according to an FDA drug safety communication

F.D.A. to Review Safety of Popular Bone Drugs

By DUFF WILSON Published: September 5, 2011 Two advisory panels of the Food and Drug Administration will consider on Friday whether to recommend requiring women who use popular bone drugs like Fosamax to take “drug holidays” because of rising concerns about rare side effects with long-term use, according to people involved in the review.

Consumer Reports: Pharmacies don’t always provide required drug warnings

By Consumer Reports, Published: August 29 We rely on drug labels and package inserts for important instructions and warnings about the drugs we take. But when Consumer Reports staff members recently picked up prescriptions from five national pharmacy chain stores, they found bottle labels and patient information sheets that were both difficult to read and lacking in information

Medical student essentials; Stethoscope, iPad

By Chelsea Conaboy, Globe Staff 08/29/2011 5:17 PM Yale School of Medicine this year will outfit all students with iPads and no longer provide printed course materials. The initiative, born out of a going-green effort, could save the school money in the long run, said Assistant Dean for Curriculum Mike Schwartz.

Actelion drug flunks PhII but safety data bolsters confidence in blockbuster PhIII

August 29, 2011 — 8:05am ET | By John Carroll Typically, when a drug fails a mid-stage study and the biotech announces it will shelve the program as a result, it's counted as a black mark. But there isn't anything typical about Actelion's development program for macitentan.

Trial Shows Blockbuster Potential for Blood Clot Pill

By DUFF WILSON Published: August 28, 2011 An experimental pill to prevent blood clots exceeded already high expectations as a better therapy for millions of people with atrial fibrillation, according to final results of a worldwide study released Sunday

Obese Patients Treated With QNEXA Demonstrated Significant Improvement in Quality of Life

MOUNTAIN VIEW, Calif., Aug. 5, 2011 PRNewswire -- VIVUS, Inc. (NASDAQ: VVUS) today announced that additional data from the phase 3 QNEXA studies will be presented today during the American Association of Diabetes Educators (AADE) meeting in Las Vegas, NV. Dr. Kolotkin, along with Duke colleagues, developed the Impact of Weight on Quality of Life (IWQOL) instrument to assess weight-related changes in quality of life. The IWQOL-Lite instrument was administered to all patients in the EQUIP and CONQUER studies. Additionally, the Short Form 36 questionnaire (SF-36), designed to assess broader health-related quality of life elements, was administered to all patients in the CONQUER clinical study.

July 2011 Safety Labeling Changes

Last Updated: 08/11/2011 The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections

Drug companies lose protections on Facebook, some decide to close pages

By Christian Torres, Published: August 12, 2011 Facebook and the pharmaceutical industry have had an uneasy partnership in recent years. Many drug companies didn’t join the site until Facebook gave them a privilege that others do not have — blocking the public’s ability to openly comment on a page Wall.

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