The senate report by the Senate Finance Committee also criticized the FDA, saying that the agency overlooked or overrode safety concerns found by its staff.

“Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them,” said U.S. Senator Max Baucus, a Democrat and committee chairman. “Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust.”

GlaxoSmithKline rejected any assertions Saturday that the drug is not safe. ”We disagree with the conclusions in the report,” company spokeswoman Nancy Pekarek told CNN. “The FDA had reviewed the data and concluded that the drug should be on the market.”

Seven clinical trials on the drug prove that it is not linked to heart attacks, Pekarek said. ”None of that data shows a statistically significant correlation between Avandia and myocardial ischemia or myocardial infarction [heart attack],” she said.

Ischemia is a condition in which blood flow and oxygen are blocked from going to certain parts of the body.

The Senate report was developed over the past two years by committee investigators who reviewed more than 250,000 pages of documents provided by GlaxoSmithKline, the FDA and several research institutes. Committee investigators also conducted numerous interviews and phone calls with GlaxoSmithKline, the FDA and anonymous whistleblowers.

“GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” the report says.

As an example, committee investigators say they found that GlaxoSmithKline experts verified an outside study showing the cardiac problem, but the company publicly attacked the findings as incorrect.

• Two FDA safety officials sounded a clear alarm in October 2008 writing, “There is strong evidence that rosiglitazone [Avandia] confers an increased risk of [heart attacks] and heart failure compared to pioglitazone [rival drug on market].” They concluded and trials comparing the two would be “unethical and exploitive.” Yet, the trial is still under way, the senators say.

The Senate report does not address the issue of whether Avandia should be removed from the market.

The FDA is taking steps to curb use of some long-acting asthma drugs taken by millions, issuing safety restrictions to lower an uncommon but potentially life-threatening risk that asthma could worsen suddenly.

Nor should LABA-containing drugs ever be used without simultaneous use of a different asthma-controlling medication, such as an inhaled corticosteroid — a move that specifically targets two of the drugs, Foradil and Serevent, the FDA said.

These four drugs contain an ingredient that relaxes muscles around stressed airways, called a long-acting beta agonist or LABA. While they’re very helpful at preventing day-to-day symptoms for some patients, the way LABA-containing drugs work also sometimes masks that inflammation is building in the airways. That means patients may not realize a serious asthma attack is brewing until they’re gasping for air.

The FDA cited studies that showed an increased risk of hospitalization and even some deaths, particularly among children. One study found three extra adverse events — mostly hospitalizations — for every thousand patients who took a LABA-containing drug compared to another asthma medication, said FDA’s Dr. Gerald Dal Pan.

FDA’s advice that patients quit the LABA-containing drugs as soon as their asthma is under control and go back to standard medications such as inhaled corticosteroids for day-to-day maintenance.

People with other lung diseases, such as chronic obstructive pulmonary disease or COPD, use the drugs without the asthma risk, and just saying they shouldn’t be used for asthma would have little practical effect, said Dr. John Jenkins, FDA’s director of new drugs. So FDA labeled LABA-containing medications as contraindicated without simultaneous use of a different asthma-controlling medication — a legal term with more enforcement muscle to limit prescription. FDA will monitor that, to see if doctors follow the rules.

Advair and Serevent are marketed by GlaxoSmithKline, Foradil by Novartis AG and Symbicort by AstraZeneca.

It was the second such recall in less than a month because of the smell, which regulators said was first reported to McNeil in 2008.Federal regulators criticized the company, saying it didn’t respond to the complaints quickly enough, wasn’t thorough in how it handled the problem and didn’t inform the Food and Drug Administration quickly.

The recall includes some batches of regular and extra-strength Tylenol, children’s Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children’s Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph’s aspirin.

The FDA and Johnson & Johnson’s McNeil Consumer Healthcare Products said they did not know the number of bottles recalled. It included caplet and geltab products sold in the Americas, the United Arab Emirates, and Fiji.

Consumers should check the full list at http://www.mcneilproductrecall.com/page.jhtml?id=/include/prd_tylenol.inc to identify the recalled batches.

The FDA said about 70 people have been either sickened by the odor — including nausea, stomach pain, vomiting and diarrhea — or noticed it.

The smell is caused by small amounts of a chemical associated with the treatment of wooden pallets, Johnson & Johnson said. The FDA said the chemical can leach into the air, and traced it to a facility in Las Piedras, Puerto Rico.

The New Brunswick, N.J., company said it is investigating the issue and will stop shipping products with the same materials on wooden pallets. It has asked suppliers to do so as well.

The FDA said McNeil knew of the problem in early 2008 but made only a limited investigation.

“McNeil should have acted faster,” said Deborah Autor, the director of the FDA’s Office of Compliance of the Center for Drug Evaluation and Research. “When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary action to solve the problem.”

The FDA sent McNeil a warning letter for violating manufacturing standards and failing to report and investigate the problem in a timely way, Autor said.

Johnson & Johnson has 15 days to respond. The FDA says it wants an explanation as to why the problem was not made public sooner.

In November, McNeil recalled some Tylenol Arthritis Caplets due to the smell. Almost three weeks ago, the company expanded its recall to include more batches of Tylenol Arthritis Caplets.

There have been no reports of nausea related to the most recent recall, the company said. McNeil, however, said the expanded recall includes product lots that could be affected by the same problems of nausea.

The company said it is working with the FDA.

Also on Friday, federal prosecutors in Boston said Johnson & Johnson paid tens of millions of dollars in kickbacks so nursing homes would put more patients on its blockbuster schizophrenia drug.

The government’s complaint states that J&J gave special rebates to Omnicare Inc., the country’s biggest dispenser of prescription drugs to nursing homes, in return for recommendations from its pharmacists that patients be given Risperdal, in many cases when it was inappropriate.

J&J said in a statement it “will address the government’s lawsuit in court” and believes its rebates were “lawful and appropriate.”

The FTC entered a final consent agreement with Constellation Brands concerning the FTC’s charges that ads for Wide Eye Schnapps caffeinated drinks were deceptive. Wide Eye Schnapps was a product containing 30 percent alcohol by volume.  Ad claims included “Wake Up @WideEye.com,” “I am your wake up call,” and “When you party with the world’s first caffeinated schnapps it’ll seem like the rest of the world is sleepwalking through life.”  According to the FTC, these claims expressly or by implication promised that consumers will remain alert while consuming Wide Eye.  A number of state attorneys general had also called on the FTC to crack down on Wide Eye, arguing that it, like other popular energy drinks, appealed to youth and underage drinkers.  Prior to product launch, Constellation had obtained all required U.S. Alcohol & Tobacco Tax & Trade Bureau (TTB) approvals for Wide Eye and the product’s brand name and tagline were subsequently found to be in accordance with the voluntary DISCUS Code of Responsible Marketing Practices.

The consent agreement, which does not constitute an admission of a violation of law, prohibits Constellation from representing “expressly or by implication, including through the use of a product name or endorsement, that such product…will counteract the effects of alcohol consumption” unless the advertiser has “competent and reliable scientific evidence” supporting that representation.  The FTC order pertains not just to Wide Eye, but also to any other alcohol product containing caffeine, ginseng, taurine, guarana, or any stimulant.  The Order puts any such Constellation products under the FTC’s close eye until the order expires in 2029.

National Alliance to Prevent Underage Drinking letter to FTC
FTC Complaint
FTC Decision and Order

If you have taken this product we would like to hear from you. Please fill in this form for a free case evaluation.

In the letter, the FDA said that it reviewed two Sotradecol web pages located on the Bioniche Pharma website (www.sotradecolusa.com or “Bioniche web page”) and the AngioDynamics, Inc. website (www.angiodynamics.com/pages/products/Sotradecol.asp or “AngioDynamics web page”) as part of its routine monitoring and surveillance program.  The agency found that these two web pages were misleading because they (1) presented efficacy claims for Sotradecol but failed to communicate any information about the risks associated with the brand, (2) broadened Sotradecol’s approved use, and (3) overstated Sotradecol’s efficacy.

Specifically, the FDA said that the Bioniche and Angiodynamics web pages “entirely omit risk information for Sotradecol.”  The letter also states that these web pages made claims that “entirely avoid mention of the actual indication, which is for the treatment of a very limited subset of varicose veins, and misleadingly suggest that Sotradecol is appropriate for use in all sclerotherapy patients and procedures.  The Contraindications and Precautions sections of the product label lists numerous conditions in which Sotradecol is either inappropriate or should be used with extreme caution, and these two web pages failed to present such material limitations and thus broadened Sotradecol’s FDA-approved indication.  Third, the FDA said that a graphic contained in one of the web pages “overstates the efficacy of Sotradecol” and “fails to provide any information regarding the ranges of the results patients may achieve depending on [several] variables.”

The FDA also expressed concern over Bioniche’s “continued violative promotion of this product,” because this is not the first time the agency sent Bioniche a letter like this.

In an earlier letter dated April 14, 2006, the FDA told Bioniche Pharma to immediately cease the dissemination of violative promotional materials for Sotradecol and to respond to the agency within four days.

In the 2006 letter, the FDA said that it reviewed a product brochure for Sotradecol that was submitted by Bioniche Pharma Group and made available on the product website.  The agency found it to be misleading because it presented numerous claims about how safe and effective Sotradecol, but failed to reveal material facts, minimized the risks associated with Sotradecol treatment, broadened the indication, included unsubstantiated claims, and presented misleading graphics.

If you have been treated with Sotradecol on or before September 14, 2009, you may be entitled to compensation.

This notice applies to all residents of Arkansas, California, Connecticut, Florida, Kansas, Missouri, New Jersey, New Mexico, New York, Ohio, South Carolina, Vermont, Washington, and Wisconsin.  If you live in one of these states, you may be eligible for compensation if you were prescribed and purchased Sotradecol on or before September 14, 2009.

The law firm of Bailey Perrin Bailey is actively reviewing potential Sotradecol cases of deceptive advertising against Bioniche Pharma USA, LLC and Angiodynamics, Inc.  Please click here to contact an attorney.

The Food and Drug Administration warned the public Tuesday not to use body-building products marketed as containing steroids or steroid-like substances.

FDA said many of the products are sold as dietary substances, but are actually unapproved and misbranded drugs.

“Products marketed for body building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” said the agency’s commissioner, Dr. Margaret Hamburg, “The FDA is taking enforcement action today to protect the public.”

The agency sent a warning letter to American Cellular Laboratories Inc., saying it markets and distributes products that are labeled dietary supplements, but that violate the Federal Food, Drug and Cosmetic Act because they do not meet the definition of dietary supplement. To be a dietary supplement, the product has to contain one or more dietary ingredients, such as vitamins, minerals, amino acids, or herbs.

The affected products are; TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT-40-Xtreme.

They are sold as muscle stimulants for body builders who want to add muscle, lose weight and retain muscle mass. Sold mostly at gyms, by mail order and over the Internet, the products claim to have steroid-like ingredients but actually contain synthetic steroids, the agency said.

Another 15 events were attributed to this type of product in general, it said.

“Due to the potentially serious health risks associated with using these types of products, the FDA recommends that consumers immediately stop using all body-building products that claim to contain steroids or steroid-like substances,” the agency said in a public health advisory.

FDA recommends that anyone taking the products stop immediately and see a doctor if they experience various side effects.

American Cellular Laboratories has been given 15 business days to respond in writing to the warning letter, outlining the corrective steps they plan to take.

FDA scientists estimated in July 2007 that Avandia was associated with approximately 83,000 heart attacks since the drug came to market.

Unfortunately, since its release in 1999, Avandia drug has been shown to increase patients’ risk of developing the following, potentially fatal side effects:

• congestive heart failure
• heart attack
• pulmonary embolism (a condition in which blood clots congest the lungs and impede breathing)
• stroke

Other serious, non-fatal Avandia side effects include bone fractures (namely in the hands and feet) and pulmonary hypertension (increased blood pressure in the lungs’ arteries).

In 2007, an FDA panel recommended by a vote of 22-1 that Avandia should remain on the market despite an analysis showing links to increased risk of heart attack. The vote was not binding, but a suggestion to FDA regulators.

The panel also voted 20-3 at the same meeting in support of data that showed Avandia increased the risk of cardiac ischemia in patients with the most common type of diabetes.

Tarceva (erlotinib) Tablets
Audience: Oncological healthcare professionals

OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Patients with hepatic impairment receiving Tarceva should be closely monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN. Dosing should be interrupted or discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside the normal range. New information from a pharmacokinetic study in patients with moderate hepatic impairment associated with significant liver tumor burden has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections.

FDA anticipates the receipt of additional data within the next several weeks. As soon as the review of these data is complete, FDA will communicate our conclusions and recommendations to the public. The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.

An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as “Lou Gehrig’s Disease.” The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.