Stoughton / Canton Area Personal Injury Lawyer - FDA & Prescription Drugs

New Proposal to Examine Drug Safety

Carrie Strasser — Wed, 25 Nov 2009 09:54:22 GMT

Yesterday, the New York Times reported that a new plan to monitor the safety of drugs could identify a particular drug's risks long before they might have otherwise been discovered. The study that devised this plan was published Monday in the Archives of Internal Medicine.

The authors propose a system to examine widely prescribed drugs through safety analyses that would pool data as they emerge from various clinical trials of a medication and aggregate the information for a fuller picture of a drug’s harms and benefits.

This database would be constantly updated as the results of studies were published. This could allow a "real-time" analysis of the various risks and benefits associated with certain drugs.

Dr. Joseph Ross is the lead author of the study and proposed this plan as a new model for post-market surveillance of drugs. Dr. Ross's study used Vioxx as an example and determined that Merck could have discovered the cardiovascular risks of Vioxx many years before it took the drug off the market in 2004.

Merck questioned the methods used by Dr. Ross and his colleagues in the study, stating that the categories used were too broad and included patients who suffered heart attacks after they had stopped taking Vioxx.

Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, stated that the type of cumulative analysis proposed by Dr. Ross's study requires an act of Congress. Although the FDA has increased its efforts to ensure drug safety in the past few years, critics call for Congress to grant the FDA more power and resources in order to provide detailed information to patients and doctors.

“There is this kind of dogma in medicine that you shouldn’t use any drug for the first seven years after it’s released, because it takes that long to figure out its harms and benefits,” said Dr. Michael Steinman, an assistant professor of medicine at the medical school of the University of California, San Francisco.

While there are many proponents of the study and its potential to identify drug dangers even faster, some say the number of drugs on the market today would make it nearly impossible, and perhaps too expensive, to cumulatively track every single one of them.

For more information on the FDA and prescription drugs, click here.

To read the study, click here.

Originally posted at InjuryBoard by Carrie Strasser

FDA Warns: Decorative Contact Lenses Can Harm Your Eyes

Chrissie Cole — Mon, 26 Oct 2009 11:21:00 GMT

With Halloween almost upon us, the FDA is warning consumers about unapproved use of decorative contact lenses that can harm your eyes.

These contact lenses are used to temporarily change the person’s eye color or to make their eyes look weird – for instance giving the wearer an “eye-of-the-tiger” look.

“Unauthorized use of decorative contact lenses is a year-round concern, but during Halloween people are more inclined to use them as a costume accessory,” says James Saviola, the Ophthalmic and Ear, Nose and Throat Devices network leader in FDA's Center for Devices and Radiological Health.

It is illegal for companies to market decorative lenses over-the-counter, yet consumers are able to buy them on the beauty salons, the Internet, video stores and various other outlets.

What troubles us is when they are bought and used without a valid prescription, without the involvement of a qualified eye care professional, or without appropriate follow-up care," says Saviola. "This can lead to significant risks of eye injuries, including blindness."

Unauthorized contact lenses of all types present risks to the eye that include corneal ulcers, corneal abrasion, vision impairment, and blindness.

Originally posted at InjuryBoard by Chrissie Cole

Risks of Ortho Evra

Carrie Strasser — Thu, 22 Oct 2009 09:58:23 GMT

The Boston Globe reported yesterday on the risks associated with the birth control patch, Ortho Evra, manufactured by Johnson & Johnson. The article reported the story of an otherwise healthy 17-year-old, Adrianna Duffy, who recently died from a pulmonary embolism after being on the patch.

Thousands of lawsuits have been brought against the makers of Ortho Evra, Johnson & Johnson, by women who used it and suffered heart attacks, strokes, or blood clots. At least 20 of the women named in the lawsuits died after using the patch. Though sales of the drug have plummeted by about 75 percent since word of its side effects spread, at least 2 million women still use it, and it’s still approved by the Food and Drug Administration.

So far, Johnson & Johnson has paid out $70 million to settle the suits. Claims arose that Johnson & Johnson was ignoring the risks that were associated with such high estrogen levels. Although Johnson & Johnson has dismissed these claims, it has changed the label on Ortho Evra three times to show its estrogen levels and to warn of the possible risks associated with such high levels.

Sidney Wolfe, director of the Health Research Group at Public Citizen, says that the estrogen levels in Ortho Evra are far higher than in birth control pills and these levels greatly increase a woman's risk for blood clots.

For more information on prescription drugs and their associated risks, click here.

Originally posted at InjuryBoard by Carrie Strasser

FDA Approves Stelara To Treat Psoriasis

Chrissie Cole — Sun, 27 Sep 2009 13:09:00 GMT

The U.S. Food and Drug Administration (FDA) recently approved a new biologic drug called Stelara for the treatment of moderate to severe psoriasis in adults.

Known generically as ustekinumab, the drug is injected in the skin and works by blocking part of the body’s immune system. After the initial shot, patients get another shot in four weeks and then one shot every 12 weeks.

Psoriasis is a chronic disease of the immune system that appears on the skin, usually in the form of thick, red, scaly patches. The disorder affects as many as 7.5 million Americans. About 30 percent of psoriasis sufferers also develop psoriatic arthritis. The condition is associated with other serious health conditions such as diabetes and obesity.

“The approval of Stelara provides an alternative treatment for people with plaque psoriasis which can cause significant physical discomfort from pain and itching and result in poor self-image,” Julie Beitiz, MD, of the FDA's Center for Drug Evaluation and Research.

Stelara is manufactured by Centocor Ortho Biotech Inc. a wholly-owned subsidiary of Johnson & Johnson of New Brunswick, N.J.

For more information on psoriasis, visit the National Psoriasis Foundation.

Originally posted at InjuryBoard by Chrissie Cole

Orlistat Weight Loss Drug Linked To Liver Damage

Chrissie Cole — Mon, 24 Aug 2009 23:40:00 GMT

The Food and Drug Administration has received several reports of liver damage associated with the weight loss drug orlistat (sold over-the-counter as Alli) and Xenical (prescription strength).

The agency has received 32 reports of serious liver injury in patients taking orlistat, between 1997 and 2008, including six cases of liver failure. Symptoms of liver failure can include weakness, fatigue, stomach pain, nausea, vomiting, loss of appetite and jaundice.

The FDA’s investigation is ongoing. The agency has not definitively established an link between orlistat and liver injury. Consumers should continue taking Xenical as prescribed and Alli users should continue to use the product as directed.

In April, the FDA looked at the issue of safety and the consumer group, Public Citizen petitioned the FDA in 2006 to remove Xenical from the market because of its link to the risk of aberrant crypt foci, a possible precursor to colon cancer.

Read the FDA's News Release.

Originally posted at InjuryBoard by Chrissie Cole

Selling Prescriptions and Patient Information - More Common Than You Think

Carrie Strasser — Sun, 09 Aug 2009 15:07:44 GMT

The NY Times reported yesterday that people's prescriptions and personal information including Social Security numbers and addresses, are often sold without a patient's knowledge or consent. This practice may decrease if some restrictions included in the federal stimulus law are strictly enforced. The federal stimulus law prohibits the sale of personal health information except in certain instances for research and public health measures. Additionally, the law includes stricter rules for informing patients when their information may have been compromised by hackers or negligent healthcare workers.

“The new rules will plug some gaping holes in our federal health privacy laws,” said Deven McGraw, a health privacy expert at the nonprofit Center for Democracy and Technologyin Washington. “For the first time, pharmacy benefit managers that handle most prescriptions and banks and contractors that process millions of medical claims will be held accountable for complying with federal privacy and security rules.”

While the new law won't cease companies from trading people's personal information, it will increase the regulations on such trades and increase the penalties of abusing the process.

Many companies argue that patients' names and other personal information are removed before the prescriptions are sold to drug manufacturers or others. However, this is not always the case.

Other's argue that tracking patient prescription data is a valuable source of health research. Gathering and analyzing such information assists researchers in identifying dangerous trends and/or side effects associated with certain prescriptions drugs.

“Data stripped of patient identity is an important alternative in health research and managing quality of care,” said Randy Frankel, an IMS vice president. As for the ability to put the names back on anonymous data, he said IMS has “multiple encryptions and various ways of separating information to prevent a patient from being re-identified.”

Under the new law, it is still permissible to sell patient prescription data to drug manufacturers as long as patients' names are removed. However, the stimulus law places a restriction on this by allowing pharmacy companies to send marketing information to customers limited to the specific drugs they are currently taking.

Some states such a Maine, New Hampshire and Vermont prohibit the collecting and selling of prescription information to drug manufacturers outright.

If you believe that your personal information has been compromised and would like more information, click here.

Originally posted at InjuryBoard by Carrie Strasser

NIH Halts Viagra Trial In Sickle Cell Patients

Chrissie Cole — Tue, 28 Jul 2009 22:11:00 GMT

A trial of sildenafil intended to determine if the drug could be used to treat pulmonary hypertension in some patients with sickle cell disease has been halted a year early by the National Institutes of Health (NIH).

The trial involved sildenafil -- marketed as Viagra when it is used to treat erectile dysfunction and Revatio when used for pulmonary arterial hypertension, or high blood pressure in the lungs. The NIH was sponsoring a study at nine U.S. hospitals and one in London.

The researchers found that 38 percent of patients taking Revatio had serious adverse effects, compared to 8 percent of patients getting a placebo.

Most episodes involved severe pain called sickle cell crises requiring hospitalization. No deaths have been linked with the drug.

Dr. Elizabeth Nabel, chief of NIH’s National Heart, Lung and Blood Institute (NHLBI) stresses that the side effects are specific to sickle cell patients and advises patients to talk to their doctors.

Sildenafil treats pulmonary hypertension by relaxing blood vessels in the lungs to allow blood to flow easier.

Nearly 30 percent of people with sickle cell disease are affected by pulmonary hypertension.

Originally posted at InjuryBoard by Chrissie Cole

Swine Flu Vaccine Makers Get Immunity

Carrie Strasser — Mon, 20 Jul 2009 13:58:16 GMT

Secretary of Health and Human Services, Kathleen Sebelius, signed a document last month that gives vaccine makers and federal officials immunity from lawsuits that might arise surrounding any new swine flu vaccine. The Boston Globe reported last week that the immunity sought by drug manufacturers was spurred on by vaccines created for the last swine flu outbreak and the resulting thousands of lawsuits filed against those vaccine makers for side effects suffered from the shots.

The document signed by Secretary Sebelius allows for a compensation fund, if needed, for claims made against the drug manufacturers. The government has taken these steps in order to encourage drug companies to actually make the vaccine and so far, five manufacturers have contracted with federal officials to make a swine flu vaccine.

The last time the government faced a new swine flu virus was in 1976. Cases of swine flu in soldiers at Fort Dix, N.J., including one death, made health officials worried they might be facing a deadly pandemic like the one that killed millions around the world in 1918 and 1919.

Federal officials vaccinated 40 million Americans during a national campaign. A pandemic never materialized, but thousands who got the shots filed injury claims, saying they suffered a paralyzing condition called Guillain-Barre Syndrome or other side effects.

Because vaccines are not as profitable to drug companies as other products, many will not pursue the manufacturing of vaccines unless immunity is guaranteed. However, some worry about the costs to consumers. Because the government will most likely campaign for people to get vaccinated to prevent further spread of the disease, some question whether or not these people will truly be protected if they are actually harmed by the vaccine.

Originally posted at InjuryBoard by Carrie Strasser

Officials Warn of Risk of Suicide with Two Anti-Smoking Drugs

Carrie Strasser — Thu, 02 Jul 2009 09:58:23 GMT

The New York Times reported that federal drug regulators advised patients taking two anti-smoking drugs to watch for signs of mental illness because of an increased risk of suicide among the drugs' users.

However, officials stressed that patients should not stop taking these drugs all together, but just be aware of increased risk of mental illness.

The two drugs are Chantix, by Pfizer, and Zyban, by GlaxoSmithKline. Zyban is also sold under the name, Wellbutrin, which is used to treat people suffering from depression.

“Stopping smoking is a goal we should all be working towards,” said Dr. Curtis J. Rosebraugh, director of a drug evaluation office at the Food and Drug Administration. “We don’t want to scare people off from trying a medication that could help them achieve this goal. You should just be careful.”

Pfizer is going to add a black-box warning to Chantix packaging and Glaxo is going to expand its already existing black-box warning on Wellbutrin to include Zyban.

Both drug manufacturers are going to conduct clinical trials to determine the extent of the mental health risks associated with these drugs.

Officials for both companies explained that it was difficult to determine whether it was the drugs causing the increased depression and suicidal thoughts, or whether it was the nicotine withdrawal associated with patients trying to stop smoking.

Despite the fear that this latest FDA action would affect drug sales, analysts say that it probably won't have much of an effect because of the previous information related to these drugs and their side effects.

Among those using Chantix, FDA officials have received 98 reports of suicides and 188 reports of attempted suicides. With Zyban, officials discovered 14 reported cases of suicide and 17 reports of attempted suicide.

For more information about the FDA and prescription drugs, click here.

To read the FDA Press Release regarding these two drugs, click here.

Originally posted at InjuryBoard by Carrie Strasser

Zicam Nasal Cold Products Recalled

Chrissie Cole — Mon, 22 Jun 2009 15:21:00 GMT

Certain over-the-counter Zicam Cold Remedy Nasal products have been recalled after the FDA reportedly received more than 130 reports of loss of smell, associated with these products.

Loss of smell, also known as anosmia, can render someone vulnerable if they cannot smell spoiled food, gas or smoke from fire, for example.

The recalled Zicam products include:

--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product)

The FDA sent Matrixx Initiatives, the maker of Zicam products, a warning letter advising the company to stop marketing these products because they are misbranded and fail to warn users of associated risks.

Matrixx Initiatives defends its products and says, "The Company believes these products are safe and do not cause anosmia." View the news release.

If you have used Zicam and experienced loss of smell or other health problems associated with these products, you should contact your health care professional.

Originally posted at InjuryBoard by Chrissie Cole