San Antonio Personal Injury Lawyer - FDA & Prescription Drugs

MRI Dye Linked to Disease

Beth Janicek — Tue, 14 Jul 2009 18:15:15 GMT

Another person has joined the 516 other plaintiffs in a massive lawsuit against the pharmaceutical companies that make certain dyes used for magnetic resonance imaging (MRI). The dye is used during an MRI to help technicians examine the tissue.

Patients with healthy kidneys can simply flush the gadolinium out of their system, but people with renal impairment can be diagnosed with nephrogenic systemic fibrosis (NSF) after being injected with the contrast agent. Patients diagnosed with NSF describe their skin turning wood-like, eventually cracking. The disease can then move to the organs where it can become fatal.

Patrick Barry of Providence law firm Morowitz and Barry, attorney for the most recent plaintiff told investigators that his client’s condition became so bad she had to have a finger amputated.

He said “Imagine if you’re wearing very right gloves then you tried to bend your fingers. It’s very tough to do and the skin will actually break down on the knuckles.”

The U.S. Food and Drug Administration issued a warning in 2006 and 2007 not to administer the drug to patients with kidney problems, but gadolinium is still used in routine MRI’s. As more people are diagnosed with NSF, the class-action lawsuit against five pharmaceutical companies that make gadolinium-based contrasting agents is getting larger.

Barry said, “We want to uncover exactly what the manufacturers knew and when. How much information did they have and what did they do with it?”

Ryan Fitzgerald, company spokesman for GE Healthcare issued a statement that says, “…no definitive causal relationship between the administration of gadolinium-based contrast agents to patients with moderate to severe renal impairment and NSF has ever been found.” However, according to Barry, the FDA researched 75 patients diagnosed with NSF, and found that each one had been administered gadolinium before their MRI.

According to the Official site of the Nephrogenic Fibrosing Dermopathy Research (AKA Nephrogenic Systemic Fibrosis) whether or not the association of NSF with gadolinium exposure is the common denominator of all NSF cases is still under investigation.

“A verifiable cause and effect relationship has not yet been established, but active efforts to prove or refute this relationship are underway.”

Originally posted at InjuryBoard by Beth Janicek

Pharmaceutical company claims controversial laxatives are safe

Beth Janicek — Wed, 01 Jul 2009 10:02:54 GMT

Six months ago, the pharmaceutical company C.B. Fleet pulled two laxative drugs from store shelves. Now, according to the Lynchburg (VA) News and Advance, the company is seeking to reintroduce thousands of cases of the recalled drugs onto the market.

C.B. Fleet, which is based in Lynchburg, is currently facing 38 federal lawsuits concerning the laxatives. The suits were recently consolidated into one federal district court (the Northern District of Ohio) in order to share pre-trial proceedings and discovery. The lawsuits allege that the recalled drugs caused serious kidney damage. Other lawsuits remain in state courts where jurisdiction rules allow.

The drugs are Fleet Phospho-soda and Fleet Phospho-soda E-Z Prep Bowel Cleansing System. Both were over the counter products classified as oral sodium phosphates. C.B. Fleet officials maintain that, when used as directed, the recalled drugs are safe. There have been discussions about making these drugs available by prescription.

The drugs Visicol and OsmoPrep are available by prescription only and the FDA is requesting a Box Warning be added to the label. The Food and Drug Administration issued a warning in December 2008, concerning oral sodium phosphates. The FDA linked them to acute phosphate nephropathy (an acute kidney injury involving a buildup of calcium phosphate crystals). The agency specifically warned that oral sodium phosphates should not be used for bowel cleansing without a prescription due to these serious risks.

The FDA also reported that acute phosphate nephropathy had developed in patients after use of an oral sodium phosphate even when the patients had no identifiable factors putting them at risk for such a kidney injury.

Originally posted at InjuryBoard by Beth Janicek

FDA Only Conducted Half of Food Safety Audits

Beth Janicek — Wed, 27 May 2009 18:40:57 GMT

According to new documents sent to Congress, the Food and Drug Administration only conducted about half of the state food safety audits it promised to do in the two years before the recent peanut salmonella outbreak. The documents show that the agency did not do any of the required audits of the state-run food inspections in five states during 2007-2008. In addition the FDA was unable to say whether audits were conducted at all in an additional 11 states. Georgia and Texas, which were linked to the wide-ranging peanut recall earlier this year, were included in that 11. Only 14 states received 100% of the audits promised.

FDA audits are to ensure that food is inspected properly by states that contract with the FDA to perform safety checks. The FDA has admitted that the food safety program is a turnaround project.

Stephen R. Mason, acting assistant commissioner for legislation at the FDA, said the recent salmonella outbreak “has highlighted limitations in our current approach and has prompted internal discussions on potential enhancements to the audit program.”

In 2000 the Health and Human Services Department, which oversees the FDA, said that the agency needed to place a high priority on better evaluating the effectiveness of state inspections of food production facilities. In response to those recommendations, the FDA set a standard that 7% of all state inspections should be audited by the federal agency. The FDA acknowledges that it has fallen far short of that goal.

In 2006-2007 audits were not done at all in Arkansas, Maryland, South Carolina, Tennessee, Texas, Virginia, West Virginia, and Wyoming, and in 2007-2008 audits were not done in California, Iowa, Kansas, Nebraska, and Wyoming. Only 9% of the promised audits were done in California during 2006-2007, in which time an E. coli outbreak in spinach caused three deaths and more than 200 illnesses.

FDA spokeswoman Susan Cruzan said “Although FDA has not been able to fulfill the goal of conducting 100% of the audits expected under FDA’s internal auditing policy, FDA has audited each state at least once, has good knowledge of the state programs and state inspection personnel, and works to improve the programs as needed.”

Congress has since vowed to step up oversight of the FDA. Several members have introduced bills to overhaul the agency, such as proposals to separate its food safety and drug oversight duties, as well as to significantly increase funding.

Originally posted at InjuryBoard by Beth Janicek

Massachusetts Bans Drug Firm Gifts to Doctors

Beth Janicek — Tue, 17 Mar 2009 09:32:00 GMT

In the past I have blogged about the potential banning of pharmaceutical and medical device companies from providing gifts to physicians, and yesterday Massachusetts state officials gave the final approval to begin regulating this common trend. The regulations include banning gifts to physicians, limiting when companies can pay for doctors’ meals, and requiring companies to publicly disclose payments to doctors over $50 for certain types of consulting and speaking engagements. In addition, companies will have to disclose payments to doctors and hospitals for research designed to promote a particular products (“seeding trials”).

Health officials said that these new regulations are the most comprehensive in the nation. Massachusetts is the only state to require disclosure by device makers and drug companies, and is just one of two states to make disclosures public. According to Legislators, these regulations are intended to control costs by reining in unnecessary prescribing of expensive drugs and to make doctors’ potential conflicts of interest transparent to the public.

Many firms say that the proposal went too far and will discourage firms from doing business.

The president of the Massachusetts Biotechnology Council, Robert Coughlin said, “Massachusetts is now seen as the most unfriendly state in the nation toward industry.”

Convention and hotel executives believe that the rules will scare away companies from sponsoring continuing medical education courses for physicians, which brings in millions of dollars into Boston.

These new regulations seem straightforward and other states should follow in making these relationships public knowledge so that their patients will know the relationship between the drug makers and their doctors.

Originally posted at InjuryBoard by Beth Janicek

Drug Maker Illegally Markets Antidepressant to Kids

Beth Janicek — Wed, 04 Mar 2009 18:19:06 GMT

Drug maker Forest Laboratories was accused by the Justice Department on Wednesday of illegally marketing the popular antidepressant Celexa to children and teens. The government alleges that the company hid the results of a clinical trial which found that Celexa was ineffective and possibly dangerous for use by children. In addition, the government also accused Forest Laboratories of paying kickbacks to doctors who prescribed Celexa or other drugs.

Forest heavily promoted results from a differing clinical trial, which showed that the drug was effective, while not disclosing the negative study to researchers or its own staff and sales representatives. They also were aware of the negative study for at least 3 years before finally acknowledging it, reports the New York Times.

In a disturbing twist, Forest is accused of not only marketing the dangerous drug, but of actually illegally convincing doctors to prescribe it. The government maintains that doctors were given baseball tickets, gift certificates, and paid vacations in exchange for prescriptions. The complaint also charges that the company separately ran so-called “seeding studies”, or trials, which were actually just marketing efforts to promote Celexa to doctors.

Celexa and Lexapro are two versions of the same drug, citalopram. The drugs are currently approved by the Food and Drug Administration only for adults. Antidepressants approved for adults continue to be widely used by doctors to treat children. But those drugs, including Celexa and Lexapro, all now carry a prominent “black box” warning that the drugs could cause suicidal thinking or behavior in some children.

The underlying problem in all this is the behavior of the doctors. Many doctors continue to prescribe dangerous antidepressants to children when there are no studies or other proof that the drugs are safe or even effective. Combine that with crooked doctors who are willing to sell out their own patients for tickets to a baseball game, and it is a bleak environment indeed for children seeking psychological help.

Originally posted at InjuryBoard by Beth Janicek

Topical Anesthetic Kills Two Women

Beth Janicek — Mon, 02 Feb 2009 13:13:12 GMT

Two young women were killed after using topical anesthetic to prepare for laser hair removal. The two women applied the topical anesthetic then wrapped their legs in plastic wrap to increase the cream’s numbing effect. Both women had seizures, fell into comas, and died from toxic effects of the anesthetic drugs. The Food and Drug Administration has issued a Public Health Advisory on the potentially serious risks associated with using topical anesthetics for relieving pain, particularly when used for cosmetic procedures.

These topical anesthetics contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment or gel and can be found in prescription and nonprescription strengths. “Topical anesthetics are widely used to numb the skin for medical and cosmetic procedures, and to relieve pain and burning and itching due to a variety of medical conditions.”

However, when the product is used in large amounts, stays on the skin for a long time, or is covered after application, the medicine can pass through the skin into the bloodstream. The anesthetic drugs can also pass into the blood stream if the skin is irritated or has a rash, or if the skin temperature goes up. If the amount of anesthetic reaches the blood in a high amount, it can cause life-threatening adverse effects such as irregular heartbeat, seizures, breathing difficulties, coma, and even death.

The FDA is particularly concerned about the serious public health risks related to compounded topical anesthetic creams and has consequently issued warnings to five firms, Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s Compounding Pharmacy, and New England Compounding Center, to stop compounding and distributing standardized versions of topical anesthetic creams.

According to Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research,

“Compounded topical anesthetic creams, like compounded drugs, are not reviewed by FDA for safety and effectiveness, and are not FDA-approved.”

Certainly, these companies need to be held accountable for any damages that result from the dangerous creams they produce but the facilities who perform the cosmetic procedures and encourage the use or misuse of these dangerous creams also need to be held accountable.

The FDA warns that if you are thinking about having a cosmetic or medical procedure it is very important to use a topical anesthetic that has been approved for that use by the FDA. The advisory goes on to list different issues that are important to consider before the use of a topical anesthetic, such as:

use a topical anesthetic approved by the FDA. Approval information is available by going to http://www.fda.gov/cder/ob/default.htm and typing in the product’s active ingredient or name. If you do not see the product, the product may not be approved.

use a topical anesthetic that contains the lowest amount of anesthetic drugs possible that will relieve your pain. Ask your doctor if the amount of anesthetic drugs in the cream is needed or advised for your procedure. There are medical procedures that use skin numbing products with high concentrations of anesthetic drugs. Ask your doctor what side effects are possible from these drugs and how to lower your chance of having life-threatening side effects from these drugs.

be sure you receive instructions from your doctor on how to safely use the topical anesthetic. This is especially important if you are having a cosmetic procedure because a doctor may not be present when you use the product. Apply as little of the cream to cover the affected skin area for the briefest period possible. If wrapping or covering the skin with any type of material or dressing is recommended or desired, be aware that this step can increase the chance of side effects.

Originally posted at InjuryBoard by Beth Janicek

FDA Warns About Diet Pills

Beth Janicek — Fri, 23 Jan 2009 07:49:00 GMT

The U.S. Food and Drug Administration expanded its nationwide alert to consumers about tainted weight loss pills that contain undeclared, active pharmaceutical ingredients. On December 22, 2008, the FDA warned consumers not to purchase 28 different products marketed for weight loss. Since then the number of weight-loss pills sold in the United States that contain undisclosed, and possibly harmful drugs, has gone up to almost 70. A few of these weight loss products are:

Fatloss Slimming
24 Hours Diet
7 Day Herbal Slim
Powerful Slim
Imelda Fat Reducer
Perfect Slim
ProSlim Plus
Slim Express 360
Superslim
Venom Hyperdrive 3.0

Click here for the complete list of tainted weight loss pills. Some of these products claim to be “natural” or “herbal” but in fact contain potentially harmful ingredients not listed on the product labels and can be potentially harmful to unsuspecting consumers. According to Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, “These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages. Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences.”

The health risks posed by consuming these products can be very serious. Sibutramine, a controlled substance found in many of these products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. The drug can also interact with other medications that patients may be taking and increase the risk of side effects. Another ingredient found in many of these products is Rimonabant, a drug that is not approved for marketing in the United States. Although it has been approved in Europe, it has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions over the last two years. The FDA's Consumer Information website lists the weight-loss products that contain Sibutramine, Rimonabant, Phenytoin, Phenolphthalein, and Bumetanide, as well as the risks associated with the consumption of each.

These health risks such as heart attack and stroke are life threatening and there are other diet pills on the market that do not carry such dangerous risks. Since these products are sold over the counter, they do not have to be FDA approved and tested. They are profitable to produce and often marketed to mislead the consumer. We are likely to see litigation result from the serious injuries caused by these drugs.

Originally posted at InjuryBoard by Beth Janicek

FDA Adds Warning of Celgene’s Risks for Elderly

Beth Janicek — Mon, 12 Jan 2009 12:54:03 GMT

Celgene Corp. added an additional warning to its blood-clot drug Innohep stating that it could increase the risk of death in elderly patients with kidney problems. Innohep (tinzaparin) is a low-molecular weight heparin used as a blood thinner or anti-coagulant approved in 2000 by the FDA to treat blood clots in patients with pulmonary embolism (PE) and deep vein thrombosis (DVT).

As of October 15, 2008, the FDA had received 383 reports of side effects and complications worldwide, including 96 deaths. The company stated that the risk only appeared for elderly patients age 90 and older, but the FDA asked Celgene to further revise the warning to include elderly patients 70 and older. Celgene posted a letter that says,

“We now regard the risks for Innohep as applying to all elderly patients with renal insufficiency and have further revised the label to include this information as a warning.”

Preliminary data does not appear to indicate a manufacturing problem with Innohep, but the FDA cannot categorically rule out this possibility until a thorough analysis of the manufacturing data is completed. Information surrounding the side effects will be evaluated to determine whether Celgene will be held liable for failing to provide adequate warnings about the risk of death.

If you or a loved one have had complications or have experienced any negative side effects due to the mistaken subscription of medicine such as Innohep contact a personal injury attorney.

Originally posted at InjuryBoard by Beth Janicek

Pharmaceutical Industry Agrees to Voluntary Moratorium on Drug Company Giveaways

Beth Janicek — Thu, 08 Jan 2009 10:19:01 GMT

Starting January 1^st, the pharmaceutical industry has agreed to a voluntary moratorium which restricts drug company giveaways- such as Viagra pens and Lipitor coffee mugs. These “branded goodies” were meant to foster good will, but some say they may “subliminally” encourage doctors to prescribe more of the drugs. However, skeptics believe that the ban is a superficial measure that does nothing to curb the amount that drug companies spend each year trying to influence physicians.

One example is Joseph Biederman, a prominent Harvard child psychiatrist, who has agreed to limit activities that are financed by the drug industry. The Massachusetts General Hospital is investigating his failure to disclose the consulting fees he received from drug makers in the past. Biederman has agreed to stop participating in activities paid for by pharmaceutical companies, such as speaking engagements and clinical trials.

According to a review by Adriane Fugh-Berman and Shahram Ahari, in 2000, pharmaceutical companies spent more than 15.7 billion dollars on promoting prescription drugs in the United States. The average sales force expenditure for pharmaceutical companies is $875 million annually. Pharmaceutical reps have access to data such as how many of a physician’s patients receive specific drugs, how many prescriptions the physician writes for targeted and competing drugs, and how a physician’s prescribing habits change over time.

Physicians must reject the “false friendship” provided by pharmaceutical reps and rely on information on drugs from indifferent sources. It is important that the relationships between medical practitioners and pharmaceutical reps remain strictly professional therefore practitioners can prescribe a particular pharmaceutical drug to a patient based on his own clinical judgment without any influence from the industry.

Two helpful organizations that deal with the relationship between pharmaceutical companies and doctors are No Free Lunch, an organization committed to raising awareness about the influence of the pharmaceutical industry on prescribing habits and Healthy Skepticism, an organization that aims to improve health by reducing harm from misleading drug promotions.

Originally posted at InjuryBoard by Beth Janicek

Rep. Barton Questions FDA Investigation of Heparin

Beth Janicek — Tue, 06 Jan 2009 12:06:40 GMT

The controversy surrounding the drug Heparin has been unfolding over the past year with reports of drug recalls and deaths and injuries as a result of contaminated Heparin. It appears, however, that some of the reports the public has been receiving contains conflicting information.

The Food and Drug Administration (FDA) began their investigation this year after news of patients having allergic reactions to Heparin. In May, the FDA contributed three deaths to the drug. In December, three officials from the FDA reported in the New England Journal of Medicine that there have been no deaths resulting from Heparin. This is puzzling because in October the FDA sent a letter to Representative Joe Barton of Texas stating that of 16 deaths involving heparin they investigated, the FDA found heparin to be the “possible” cause of death in three cases and the “probable” cause of death in one case.

As a result of this conflicting information, Rep. Barton sent a request to the Government Accountability Office (GAO) asking them to review the FDA’s handling of the heparin issue. In his letter Rep. Barton also points out that the FDA linked one of their “probable” heparin related deaths to drugs made by the American Pharmaceutical Partners APP company, but the APP drugs were never implicated in the heparin recall and the companies own investigation found no links from the heparin they manufactured to the deaths reported. For more details, a copy of Rep. Barton’s letter to the FDA can be found here.

In the end we have medical journals, pharmaceutical companies, and the FDA giving conflicting information about Heparin and the risks it poses to patients. The public deserves clear answers and thorough investigations when it comes to potentially deadly drugs. Maybe Rep. Barton’s letter will initiate some discovery into the truth on Heparin.

Originally posted at InjuryBoard by Beth Janicek