Entries in Lipitor (7)


Glass Particles Found in Generic Version of Lipitor

Brand X Pictures/Thinkstock(WASHINGTON) -- The pharmaceutical company that makes the generic version of the cholesterol-lowering drug Lipitor, also known as atorvastain, has shut down production while it tries to figure out how tiny glass particles got into the pills, the Food and Drug Administration announced on Thursday.

The federal agency said it had not received any reports of patients being harmed by the glass particles found in pills manufactured by Ranbaxy Pharmaceuticals.

Earlier this month, the company, which is the largest producer of the generic version of Lipitor, recalled more than 40 lots of the drug because of the glass contamination.

The company has not said where the generic drug was manufactured or how the problem occurred, but a spokesperson for the FDA said Ranbaxy has agreed to stop making the pill’s active ingredient until an investigation is complete.  The active ingredient is made in India.

The incident is the latest episode in a recent history of manufacturing lapses at the company.  Earlier this year, Ranbaxy was barred from importing 30 drugs after federal authorities discovered the company had numerous record-keeping violations and manufacturing problems at overseas facilities.

Dr. Edward Boyer at the University of Massachusetts Medical School said the contamination is not necessarily a threat to a person’s health, but it is a cause for concern.

He says eating a pill that has particles of glass a millimeter in size or less is akin to swallowing a pill containing small bits of sand.  Still, Dr. Boyer said if a patient on the medicine came to him, he would recommend they replace it with a known, safe alternative.

Copyright 2012 ABC News Radio


FDA Announces New Warning Labels for Cholesterol Drug

iStockphoto/Thinkstock(WASHINGTON) -- Federal regulators announced on Tuesday they would add additional safety warnings to the labels on statins, a class of drugs that lower cholesterol.

Statins -- more commonly known by the brand names Lipitor, Crestor and Zocor -- inhibit the enzyme that plays a big part in the liver's production of cholesterol.

The U.S. Food and Drug Administration now requires that statin labels include warnings about the rare, but serious risk of liver damage, memory loss and confusion along with type 2 diabetes.  Certain statins, known by the generic name lovastatin, can raise the risk of muscle weakness.

The decision came following an internal meeting between the FDA's Office of Surveillance and Epidemiology and Office of New Drugs, according to Dr. Amy Egan, the FDA's deputy director of safety in the division of metabolism drug products.

Egan said most of the information reviewed, especially the effect of statins on memory loss, came from a small number anecdotal reports compiled over one year.  She added that the warning for memory loss was more for serious cognitive problems than simple forgetfulness.

"We can't establish causality with statin therapy," said Egan, regarding the new warnings.

Most of the studies the division evaluated were short-term studies, suggesting that the long-term effects of statin therapy were unclear.  Egan also said it had yet to be determined which statins and at what dose could increase the risk of the listed side effects.

Many experts said the added labels should not deter patients from statins.  Instead, they should report any side effects they experience to their physician.

Consumers will be able to see the label changes on their medications within the next 30 days, Egan said. 

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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


Consumers Will Pay Half as Much for Generic Version of Lipitor

Brand X Pictures/Thinkstock(NEW YORK) -- Angus Hepburn, of Beacon, N.Y., has been taking Lipitor, a cholesterol-lowering drug, since 2009, after he had a heart attack. He credits the drug with helping him bring his cholesterol level down to a healthy level.

Lifesaving as Lipitor may be, it's expensive. Hepburn, who has an employer-based health plan with pharmacy benefits manager MedCo Health Solutions, said he pays about $200 every three months in co-payments and deductibles to take the brand-name drug.

But Hepburn and the 8.7 million Americans who take Lipitor, which is in a class of drugs called statins, for their high cholesterol are in for a pleasant change. On Wednesday, the drug's patent expires, opening the market for cheaper, generic versions of Lipitor, which should lower costs for consumers by about 50 percent.

Lipitor has been a moneymaker for its manufacturer, Pfizer. In 2010 alone, the drug earned the company more than $5.3 billion in U.S. sales. Many patients have been eagerly awaiting the patent's expiration and the money it will save them on their prescriptions.

Dr. Nieca Goldberg, medical director of the New York University Women's Heart Program, said many of her patients have asked about the release of a generic Lipitor.

Hepburn said Lipitor's going generic is the best news he's heard in a while.

"If I want to stay alive, I've got to keep taking these things," he said. "You've just got to bite the bullet and pay the charges until something like this happens."

For patients currently taking Lipitor, here are answers to the questions that will inevitably arise when the Lipitor patent expires and the drug goes generic:

Will the generic version be the same as Lipitor? Although the new pill may look different and will cost less, doctors say the generic version of the drug, called atorvastatin calcium, will be basically the same as the brand version. To receive approval from the U.S. Food and Drug Administration, generic drugs must contain the same active ingredients as their original patented counterparts.

What will happen when I need to refill my Lipitor prescription? Consumers can still get a Lipitor prescription filled at their pharmacies once the drug's patent expires. But whether they get the brand-name drug or the generic will depend on what kind of health insurance plan they have. Some plans automatically require consumers to get less-expensive generic drugs, if they exist, while other plans leave it to consumers to decide if they want to pay higher co-payments for the brand-name drugs.

Another question remains about whether initial supplies of atorvastatin will be sufficient to meet demand from consumers who want to switch to the generic right away. Ranbaxy Laboratories, the manufacturer with exclusive rights to sell atorvastatin for the first 180 days of the patent expiration, did not respond to requests for comment about its initial supply of the drug.

Experts say patients should check with their pharmacists about whether atorvastatin is available and covered by their health plans. They should also check with their doctors to learn if their prescriptions specify that they take Lipitor, and ask if a switch to the generic is possible.

How much money will I save by switching? Most experts say consumers can expect to pay about 50 percent less for atrovastatin as they did for Lipitor. Co-payments for Lipitor range from $25 to about $50, depending on a patient's health plan. Co-payments for the generic form of the drug will drop to $10.

After the next 180 days, Ranbaxy's exclusive rights to sell the generic drug will expire, opening the door to even more manufacturers, which could drive prices down even further. But many experts say consumers will see the biggest price differences as soon as the drug goes generic on Wednesday.

What if I want to keep taking Lipitor? Some health plans allow patients to choose to stay on Lipitor and pay the difference between the brand and generic cost. Consumers should check on the policies of their health plans and their state regarding mandatory prescriptions of generic drugs.

Patients can get Lipitor directly from Pfizer. The company has set up a discount program called Lipitor for You, which will allow participants to sign up and receive a discount card to get Lipitor for $4 a month. Pfizer has negotiated with health plans to make the drug available at or lower than the rate of generic drugs for the next 180 days.

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


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


Pfizer Calls for Expansion of Lipitor Recall

Photo Courtesy - Getty Images(WASHINGTON) -- Pharmaceutical manufacturer Pfizer, announced the expansion of an ongoing recall for Lipitor, a drug intended to lower cholesterol in patients.  The decision to expand followed the discovery of more bottles of the drug that give off a musty odor.

The latest recall will included an additional lot of 19,000 bottles of 40 mg Lipitor pills, which will bring the total number of bottles removed from shelves to 360,000.

Pfizer said in a statement that the musty odor is likely coming from a chemical called 2,4,6-tribromoanisole (TBA), which was previously identified in a bottle of Lipitor causing one of the original consumer complaints. The FDA says the health effects of TBA are "minimal," causing mainly gastrointestinal distress in consumers of the product.

The original Lipitor recall began in August, but was only announced in October after additional lots were included.  The supplier changed its methods to resolve the problem in August, but Pfizer said the lots involved in the newest recall may have been distributed before then.

"Product filled in bottles made by the supplier prior to those changes may still be on the market, so it is possible that additional recalls could be necessary," Pfizer said.

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