Entries in Pfizer (11)


Pfizer Pulls Breast, Colon Health Claims from Centrum Labels

Scott Olson/Getty Images(NEW YORK) -- Pfizer, accused of deceptive advertising, has agreed to remove the "breast health" and "colon health" claims from the labels of Centrum vitamins.

The Center for Science in the Public Interest, a consumer advocacy group, threatened to sue Pfizer, insisting "those claims of breast and colon health implied that the supplements would prevent breast and colon cancer -- disease prevention claims that supplement manufacturers can't legally make."

"Breast health" and "colon health" appear on different Centrum products.  Other Centrum vitamins have labels claiming they promote "heart health," as well as having wording that implies the vitamins provide an energy boost.

Pfizer also agreed to change the wording on the labels containing the heart and energy claims.  The company will add "Not a replacement for cholesterol-lowering drugs" along with the "heart health" wording.  And on packages with statements about energy, there will be additional information to make it clear that the product does not boost energy.

"For many consumers, a daily multivitamin is an expensive insurance policy to make sure that one's getting the recommended daily amounts of important vitamins and minerals," CSPI litigation director Steve Gardner said in a statement.  "But supplement manufacturers must not mislead consumers into thinking that these pills will help ward off cancer."

Pfizer said in a statement that it disagrees with CSPI, but agreed to make the changes to resolve the matter.

Copyright 2012 ABC News Radio


Pfizer Recalls 28 Lots of Birth Control Pills over Effectiveness

PRNewsFoto/Amgen(NEW YORK) -- Pfizer announced on Tuesday it is voluntarily recalling 28 lots of birth control pills over a packaging error that may, "leave women without adequate contraception, and at risk for unintended pregnancy."

The drugmaker said an investigation found that some of its packs contained the wrong number of active or inert tablets, causing them to be out of sequence.  A typical package contains 21 active pills and seven inert, or sugar, pills.

The recall affects 14 lots of Lo/Ovral-28 tablets and 14 lots of generic Norgestrel and Ethinyl Estradiol tablets.  The birth control pills were distributed to warehouses, clinics and retail pharmacies across the U.S.


While the, "packaging defects do not pose any immediate health risks," Pfizer said, "consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately."

Copyright 2012 ABC News Radio


Plug Pulled on Once-Promising Alzheimer's Treatment

iStockphoto/Thinkstock(NEW YORK) -- Dimebon worked well as an antihistamine but not so much as a treatment for Alzheimer's disease.

There was hope that the drug could be used to help thwart the onset of mild to moderate Alzheimer's disease based on successful phase III clinical testing in 2008.

However, Pfizer and Medivation, which were co-developing Dimebon, admitted Tuesday that subsequent late-stage testing showed that the drug had little effect in stemming the most common form of dementia that has been on the increase as the population ages.

Researchers said they had gone further along with the drug than in previous treatments for Alzheimer's, making the decision to pull the plug that much more frustrating.

While not approved for use in the U.S., Dimebon was used for years in Russia as an antihistamine to treat nasal congestion.

Copyright 2012 ABC News Radio


Senators Pan Pfizer’s Plan to Block Generic Lipitor

PRNewsFoto/Amgen(WASHINGTON) -- Pfizer’s plan to persuade health insurance and benefits companies to favor Lipitor over its new generic competition has three Senators crying foul.

The patent on Lipitor, the cholesterol-lowering statin that earned Pfizer more than $5.3 billion in annual U.S. sales, has now expired, opening the door for cheaper generic versions.  But Pfizer is offering large discounts to pharmacy benefit managers -- the middlemen between drug companies and health insurance providers -- that block the competition.

“Consumers and taxpayers foot the bill when drug benefit companies and insurers manipulate the marketplace to prevent access to generic drugs for millions of Americans,” Sen. Herb Kohl, D-Wis., said in a statement.  “We hope that scrutiny into these business practices will restore fairness and open the gates to affordable prescription drug choices and tremendous cost savings.”

Kohl joined Sens. Max Baucus, D-Mont., and Charles E. Grassley, R-Iowa, in asking Pfizer, three pharmacy benefit companies and two insurance companies for more information about the agreements, citing concerns about the impact on health care costs.

“By working with manufacturers to push brand-name drugs, drug benefit companies may be abusing Medicare to boost their profits and denying generic alternatives to patients -- a practice that needs to end immediately,” Baucus said in a statement.  “We need to take a close look to ensure we’re protecting both taxpayer dollars and access to the medicine patients need.”

Under Pfizer’s plan, which was first reported by The New York Times, the co-pay for a 30-day supply of Lipitor would drop to $10 -- the same co-pay as generic versions.  The Senators worry pharmacy benefit managers will continue charging employers and Medicare the full cost of the drug and pocket the difference.  In letters to the companies, they’re asking for clarification.

On Wednesday, the U.S. Food and Drug Administration approved the first generic version of Lipitor, made by Ranbaxy Laboratories Ltd.  Ranbaxy has exclusive rights to sell the generic for 180 days, during which time it will be Lipitor’s sole competitor.

In an email to ABC News, Pfizer spokesman MacKay Jimeson said the Senators’ letter is based on “incomplete and incorrect information.”

“Our intent is to offer Lipitor to payers and patients at or below the cost of a generic during the 180-day period.  As a result, patients receive Lipitor at co-pays comparable to generics,” he wrote.  “Participation in Pfizer’s programs by a health plan is entirely voluntary.  It is not imposed on any plan either by Pfizer or their [pharmacy benefit manager].”

The Senators asked the companies to respond to their letters no later than Dec. 21.

Copyright 2011 ABC News Radio


FDA Should Warn Smokers of Increased Psychological Dangers of Chantix, Study Says

Brand X Pictures/Thinkstock(WINSTON-SALEM, N.C.) -- Scientists say the U.S. Food and Drug Administration (FDA) should take warnings about the stop-smoking drug Chantix up a notch, citing data showing that the drug increases suicidal behavior and depression far more than other drugs and methods designed to help smokers quit.

Chantix, also called varenicline, has been hotly debated since 2007, when experts first raised questions about the long-term safety of the drug and its connection to cardiovascular problems and vision lapses.  Since then, studies have reported that patients taking Chantix are at increased risk of depression and suicidal thoughts.  Anecdotally, patients report wild dreams, inexplicable violent behavior and other psychological disturbances while on the drug.

In 2009, the FDA placed a "black box" warning label on Chantix and another drug, Zyban, cautioning doctors and patients about the risk of depression, hostility and suicidal thoughts.

But some researchers say these warnings don't go far enough.  On Thursday, a study published in the journal PLoS One continued to sound the alarm against Chantix and urged the FDA to update Chantix's warning label, saying the psychological risks of the drug exceed those of nicotine replacement drugs or even its competitor, Zyban.

Dr. Curt Furberg, a professor of public health sciences at Wake Forest Baptist Medical Center and one of the study's authors, said people trying to kick their tobacco habit generally are at higher risk for psychological symptoms, but Chantix makes them far worse.

"The dramatic increase of these symptoms is caused by the drug.  Among all the treatments we have for smoking cessation, Chantix is the worst," Furberg said.

In the study, Furberg and his colleagues analyzed more than 3,000 reports of suicidal behaviors or depression in people taking Chantix, Zyban, or nicotine replacement drugs, which were reported to the FDA through its Adverse Event Reporting System from 1998 through September 2010.  Of those reports, 90 percent were linked to Chantix.  In reports of completed suicides of people taking these stop-smoking treatments, the study said 92 percent were associated with Chantix.

The FDA is unmoved by this latest report. A spokeswoman for the agency said the drug is a safe and effective way to help smokers quit.  Additionally, the agency noted that this latest study failed to account for an uptick in reports of psychological side effects from Chantix that occurred as media coverage of the drug increased since 2007.

Pfizer, Chantix's manufacturer, also took issue with the data Furberg and his colleagues used in their study, saying that their reports of negative side effects are unreliable.

Pfizer also noted that at the FDA's request, the company is conducting a clinical trial to study the link between Chantix and psychological side effects.  The results are expected in 2017.

Copyright 2011 ABC News Radio


New Lung Cancer Pill Highlights Improved Way of Treating Patients

Jupiterimages/Thinkstock(NEW YORK) -- A new drug to combat a certain type of lung cancer is being hailed Tuesday as an "amazing development" by medical experts.

The drug crizotinib (Xalkori), manufactured by Pfizer and approved last week by the Food and Drug Administration, is intended for a small number of patients.

The twice-daily capsules are meant for patients with non-small cell lung cancer who have a unique gene known as an abnormal anaplastic lymphoma kinase (ALK). An ALK gene causes cancer growth and development.

Pfizer held a panel Tuesday to discuss the implications of the new drug.

"What we've seen from studies to date is that this pill does have significant activity," said Dr. Alice Shaw, a thoracic oncologist at Massachusetts General Hospital Cancer Center, who took part in crizotinib studies. "For about 60 percent of patients, they will have a significant shrinkage in their tumors and what the preliminary studies have also shown is that the median or average duration of response is on the order of 10 months."

Crizotinib works by blocking the proteins produced by the ALK gene. The FDA also approved a diagnostic test by Abbott Laboratories that screens for the gene. Patients found to have the gene would be able to be prescribed the pill, although chemotherapy and radiation therapies would remain options.

The most common side effects, according to Medpage Today, reported in patients taking crizotinib were vision disorders, nausea and edema.

"For many patients, this drug has been a lifesaver," Massachusetts General's Shaw told ABC News. "For many patients, they experienced a very immediate and significant relief in their symptoms, sometimes within the first week."

Dr. Roy S. Herbst, chief of medical oncology at Yale Cancer Center, said that crizotinib's FDA approval was a "pivotal milestone" in lung cancer treatment.

"It's another example of how we are using molecular medicine to effectively treat a subset of cancer patients," Herbst told ABC News via email.

Copyright 2011 ABC News Radio


Pfizer Looks to Introduce Non-Prescription Lipitor Drug

PRNewsFoto/Amgen(NEW YORK) -- Pfizer is looking to introduce a new version of its popular cholesterol-lowering pill, Lipitor that consumers would be able to buy without a doctor’s prescription, according to a source close to the situation.

Lipitor is the world’s best selling drug and is set to lose its patent in November. If the effort is successful, this new over-the-counter version could help Pfizer squeeze new sales life out of the drug, allowing it to retain more of the $11 billion annual revenue that it has been generating.

The nonprescription version will likely not be released immediately after the prescription Lipitor expires because Pfizer will have to convince the FDA that it is safe to take without a doctor’s prescription.

Copyright 2011 ABC News Radio


Pfizer Pulls Animal Drug After Arsenic Found in Chickens

PRNewsFoto/Amgen(WASHINGTON) -- The drugmaker Pfizer has stopped selling 3-Nitro, a widely used animal drug, after arsenic was found at elevated levels in livers of chickens treated with the product.

The FDA says it is concerned about "a very low but completely avoidable exposure to a carcinogen" in the drug, which is used "to help control coccidiosis, a parasitic disease that affects the intestinal tracts of animals," according to the Food and Drug Administration (FDA).

The drug "has also been used for weight gain, feed efficiency and improved pigmentation,” the FDA said.

"FDA officials stress that the levels of inorganic arsenic detected were very low and that continuing to eat chicken as 3-Nitro is suspended from the market does not pose a health risk," the agency said.

Copyright 2011 ABC News Radio


Pfizer Accused of Under-Reporting Side Effects of Stop-Smoking Drug

Brand X Pictures/Thinkstock(WASHINGTON) -- Everyone knows smoking cigarettes can kill you, but so might drugs that are supposed to help you kick the habit.

While severe side effects from the smoking-cessation drug Chantix have been documented for years, it turns out that suicides resulting from using the product made by Pfizer Inc. were actually more than twice in number than the pharmaceutical company admitted.

It's all there in a new analysis by the Institute for Safe Medication Practices (ISMP), which says that there were 150 instances of Chantix users taking their lives out of the nearly 600 delayed reports of severe issues noted in the study.

The Food and Drug Administration contends that Pfizer covered up the actual number of suicides by submitting information through "improper channels."  As a result, the FDA wants the drug maker to resubmit thousands of records to get a clearer idea of just how widespread severe reactions to Chantix are, which also include vivid nightmares, depression and violent outbursts.

One ISMP scientist said of the data, "It’s really chilling.  This seems to unleash something in people.  It can be violence to anything around.  We’ve had a major breakdown in safety surveillance."

While Pfizer says it will comply with the FDA request, the company contends there's no concrete evidence Chantix causes suicides.

Last year, the drug was prescribed 3.2 million times worldwide.

Copyright 2011 ABC News Radio


Lipitor Among Top Drugs Coming Off Patent by Year's End

Jupiterimages/Thinkstock(SANTA MONICA, Calif.) -- There could soon be some good news for consumers weary of soaring health care costs: The patents for several best-selling medications will expire this year, clearing the path for lower-cost generics to take their place.

According to IBIS World, an industry research firm, some of the blockbuster drugs whose patents expire this year are the cholesterol buster Lipitor, the antipsychotic Zyprexa, the antibiotic Levaquin, Concerta, a drug used to treat attention deficit disorder and attention deficit-hyperactivity disorder, and Protonix, an antacid.  Together, these drugs brought in more than $10 billion in sales in 2010.

Pfizer, the manufacturer of Lipitor, managed to hold off competition until later this year.  Ranbaxy, an India-based pharmaceutical company, agreed to delay the release of its generic version of Lipitor until Nov. 30.  According to its website, Ranbaxy will have the exclusive right to sell its drug in the U.S. for six months.

Experts say when generic versions of these drugs make it to market, pharmaceutical companies could face billions in potential losses, while consumers could save tens of billions of dollars a year.

"Studies suggest that the average cost of generics is 71 percent less than the cost of brand-name drugs," said James Zhang, associate professor and director of the Pharmaceutical Economics and Policy Research Program at Virginia Commonwealth University's School of Pharmacy in Richmond, Virgnia.  "Studies also suggest that generic drug use accounts for 63 percent of drug use."

Copyright 2011 ABC News Radio

ABC News Radio