Nationwide Voluntary Recall of Propafenone HCL Tablets: Oversized Tablets

One lot of Propafenone HCL 225 mg Tablets sold in 100 count bottles in the United States is being voluntarily recalled to the consumer level as a precautionary measure.

The lot is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. The recalled tablets were manufactured by Watson Laboratories, Inc. The affected lot of Propafenone HCL tablets was shipped to customers between October 15, 2008 and November 26, 2008. No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall. The Company has notified the U.S. Food and Drug Administration (FDA) of the recall.

Propafenone is a drug product used to treat cardiac arrhythmias (irregular heartbeats). It has a narrow therapeutic index, so some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. Consequently, as a precautionary measure, Watson is recalling this one lot to the consumer level to minimize any potential risk to patients.

Anyone who has 225 mg Propafenone HCL tablets should check the bottle for the lot number and expiration date to see if they have tablets being recalled.

Alabama: Hydroxycut Information

Bunch and James have been investigating Hydroxycut related injury claims; their firm is Alabama. Their # is 888-422-2882, and their site is bunchandjames.com

The product Hydroxycut Max has these ingredients:

The active ingredients in Hydroxycut Max are: green tea extract, caffeine anhydrous, xanthinol nicotinate, yohimblne HCI, black tea extract, wu long tea extract, rooibos tea extract, cissus quadrangularis extract, soy isoflavones, rose hip powder, hibiscus extract, garcinia cambogia extract, L-lysine HCI, diacylglycerol, dandelion powder, juniper powder, terminalia chebula powder, angelica keiskel powder, mangosteen extract, chaste extract, citrus peel, soy phospholipids, raspberry extract, and policosanol. The inactive ingredients include: sesame oil, gelatin, FD&C Red No. 40, caramel color (may contain sulfites and wheat), polysorbate 80, ink (shellac, dehydrated alcohol, isopropyl alcohol, butylalcohol, propylene glycol, sodium hydroxide, povidone, titanium dioxide).

On one site, there are these disadvantages:
Disadvantages

* The product is expensive compared with similar products.
* Hydroxycut Max contains over twenty unexplained ingredients.
* No money-back guarantee is evident on the manufacturer’s website at this time.
* Consumers cannot purchase this product directly from the manufacturer.

Source here.

More on Reglan, Octamide and Maxolon

Some have emailed asking what is Metoclopramide.

Metoclopramide is used to treat the slow stomach-emptying that can occur in diabetes, and as a second-line treatment for heartburn caused by gastroesophageal reflux. It's sometimes used for the nausea and vomiting that accompany cancer treatment, and migraines.

Regulan or its generic stimulates the stomach to move things along, reducing fullness and reflux of the stomach's contents. It also quashes the urge to vomit. It works by blocking dopamine, a neurochemical that induces vomiting and stomach-slowing.

What is TD?

Tardive dyskinesia is a disorder in which the tongue, mouth and jaw move uncontrollably in abnormal ways. Movements can include eye-blinking and face-jerking, and can occur elsewhere on the body. The movements are "pretty much constant," says Dr. Jeff Bronstein, a neurologist at UCLA's David Geffen School of Medicine, except during sleep.

The disorder can persist for months and years, and in some cases appears to be permanent. Severity can vary, Bronstein says. "Some people can get so bad it's hard for them to eat and swallow because of their tongue movements. And obviously, cosmetically, it's horrible."

Tardive dyskinesia occurs as a side effect of drugs that block dopamine. Once diagnosed, patients are usually taken off the drug. In some patients, the symptoms get better. In many cases, it becomes a permanent neurological disorder. No standard therapy exists, but various drugs have been used as treatments.

How big is the risk?

Jankovic analyzed all 443 tardive dyskinesia patients seen over 25 years at his Baylor clinic. Prior to 2000, the antipsychotic Haldol was the main culprit; since then, metoclopramide has moved to first place.

"It is a public health problem," Jankovic says. "Many of these patients who have metoclopramide-induced movement disorders aren't recognized until . . . they're at pretty advanced stages of the disease."

The main way to limit the risk is by limiting how long the drug is used. The drug is already labeled for short-term use, defined as four to 12 weeks. But a 2007 FDA study found that 20% of patients were prescribed the drug for longer than this.

Researcher Faked Data for 21 Studies

Medical journals have been asked to retract 21 studies that touted the benefits of Vioxx, Celebrex and other drugs. According to The Wall Street Journal, Baystate Medical Center, Springfield, Mass. is asking the journals to make the retractions because its former chief of acute pain, Dr. Scott S. Reuben, had faked data used in the studies.

According to The Wall Street Journal, these studies had a great deal of influence on the practice of medicine. Because of Reuben's "research", it had become routine for doctors to combine the use of painkillers like Celebrex and Lyrica for patients undergoing common procedures such as knee and hip replacements, the Journal said.

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Bills Pending In the Georgia Legislature for 2009

Just a few days remain before what is called crossover day - when a proposed bill must crossover to the other chamber. Here is a list of bills pending, with a hat tip to the GTLA blog:



SB 39 and HB 277 - Two approaches to transportation funding are moving through the General Assembly. The Senate passed SB 30 that would allow a one-penny sales tax for transportation (TSPLOST) to be approved for the metro Atlanta region and in individual counties outside metro Atlanta. The legislation was sent to the House, where it has been put on the back burner while House members consider their own transportation funding solution. The House passed HB 277, which provides for a ten-year, statewide sales tax for transportation with specific projects listed in the legislation. Status: It is likely that a conference committee will be formed to work on a consensus proposal for transportation funding before the Governor for signature or veto.
SB 54 - Prohibits abusive home loan practices as part of the Georgia Fair Lending Act. Status: Senate read and referred to committee.

SB 55 - Alters factors to be considered in determining fair market value of real property in relation to ad valorem taxes. Status: Senate passed, read second time in House.

SB 60 - Authorizes each local board of education to determine the maximum age of mandatory education from 16 to 18 for its local school system. Status: Senate read and referred to committee.

SB 71 - Prohibits engaging in certain outdoor sporting activities while under the influence of alcohol, drugs, and other substances. Status: Senate read and referred to committee.

SB 83 - Increases the amount of the statewide homestead exemption for ad valorem taxes. Status: Senate Passed, House Committee favorably reported, passed House vote on March 4, House voted to reconsider on March 5.

SB 84 - revise provisions relating to eligibility for election as a local board of education member; limit the size of local boards of education; revise provisions relating to per diem and expenses of local board of education members; provide for the fundamental roles of local boards of education and local school superintendents; prohibit certain conflicts of interest of board members; provide for a code of ethics for local board of education members. Status: Passed in Senate, read a second time in House.

SB 90 - Establishes vouchers to use taxpayer funds for families to pay private school tuition. Status: Senate committee favorably reported, read a second time in the Senate.

SB 108 - Provides tort reform to allow the charging of attorney fees to plaintiffs when a judge grant's a defendant's motion to dismiss. Status: Senate Committee favorably reported, read a second time in Senate.

SB 142 - Creates the Georgia Family Violence Offender Registry and enhances penalties for an act of family violence. Status: Senate read and referred to committee.

SB 169 - Restricts stem cell research in Georgia; provides that it shall be unlawful for any person or entity to intentionally or knowingly create or attempt to create an in vitro human embryo by any means other than fertilization of a human egg by a human sperm; provides for standards for physicians and facilities performing in vitro fertilizations; defines a living human embryo as a person, not property; prohibits the destruction of a living human embryo for any reason, such as disposal of unwanted frozen embryos kept at a fertility clinic or scientific research. President Barack Obama has announced a lifting of restrictions on federal dollars for such research. Status: Senate Committee favorably reported.

SB 175 - Provides for a moratorium on the administration of a death sentence. Status: Senate read and referred to committee.

SB200 and HB605 - proposed by Governor Perdue with the support of Lieutenant Governor Cagle and Speaker Richardson, would implement sweeping changes in statewide transportation planning, including the merging of the Georgia Regional Transportation Authority (GRTA) and the State Road and Toll way Authority (SRTA) into a new State Transportation Authority (STA), which would be responsible for planning, policy and funding decisions. The current Department of Transportation would remain responsible for operations, maintenance and certain construction projects. SB200 passed the Senate on March 5. HB 605 has been read a second time in the Senate.

HB 39 - Cigarette tax increase in the amount of $1 per pack - currently in the House Ways and Means Committee. Status: Read a second time in the House.

HB 67 - Suspending exemption on sales and use tax on certain food and beverages, reinstating a four-cent sales tax on groceries. Status: House Committee favorably reported.

HB 118 - Mid-year adjustments to the current year's budget, including reinstatement of the Homeowners Tax Relief Grant to local governments. Status: passed both House and Senate, now in conference before going before the Governor for signature or veto.

HB 119 - Fiscal year 2010 budget including a 10 percent cut in spending and a $1.2 billion stimulus package - currently in the House Appropriations Committee.

HB 160 - "Super Speeder" bill to boost fines $200 for drivers exceeding 85 mph on interstates and 75 on other roads. Also increases the fees paid for reinstatement or restoration of suspended or revoked drivers' licenses. Passed the House on Monday (March 9) and headed to the Senate.

HB 209 - Allowing the use of valid student identification cards issue by a public or private college or university in Georgia as proof of identity in order to vote. Status: House Committee favorably reported.

HB 228 - Reorganizing and reestablishing various state health and human services agency and reassign various functions of the Department of Community Health and the Department of Human Resources and abolish the Board of Community Health and the Board of Human Resources and establish the position of State Health Officer and the Behavioral Health Coordinating Council. Status: House Committee favorably reported.

HB 261 - Providing for an income tax credit for a limited period of time for the purchase of one eligible single-family residence. Status: House Committee favorably reported.

HB 277 - Levying a 1 percent sales tax statewide for specific transportation projects over the coming 10 years - passed the House, currently in the Senate Finance Committee. Status: Passed house, read in Senate and referred to Senate Committee.

HB 385 - Repealing the date on which the State Commission on Family Violence shall cease to exist. Status: House Committee favorably reported.

HB 517 - Imposing a cap on property assessment increases at the inflation rate or 3 percent. Status: Read a second time in the House.

51 resolutions under consideration in the Georgia General Assembly. Many are associated with House or Senate Bills currently under consideration. Adopted resolutions are constitutional amendments to the Georgia Constitution and require voter approval following adoption and signature by the Governor. For a complete list of Resolutions and their status, see the link posted above.

FDA - Political Lobbying Drove Process on a Medical Device Application

From the WSJ:

"The recent approval of a new device to treat knee injuries followed a lobbying campaign that overcame repeated rejections by scientists within the Food and Drug Administration, agency documents show.

The FDA's internal dissent over Menaflex, which targets the most-common knee injury afflicting everyone from high-school athletes to baby boomers, is straining a government agency that oversees a quarter of the U.S. economy. Some senior FDA staff members complained in documents that the handling of Menaflex, made by ReGen Biologics Inc., shows how political and industry pressure can influence scientific conclusions."

For the rest of the story, go here.

Reglan Gets a Blackbox Warning: Tardive Dyskinesia

News about Reglan:


What is Reglan? Reglan is used for the short-term treatment of heartburn in patients who have already tried other medications but had no relief of symptoms. The way that Reglan works is that it increases the muscle contractions in the upper digestive tract, which in turn speeds up the rate at which the stomach empties into the intestines. People that suffer from diabetes sometimes suffer from a slow gastric emptying, which can cause nausea, vomiting, heartburn, loss of appetite, and a feeling of fullness after meals, so they take Reglan as well.



In February of 2009, the FDA issued a warning about Reglan:


Agency warns against chronic use of these products to treat gastrointestinal disorders

The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.

Manufacturers will be required to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.



Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.



Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

United States Supreme Court Rules for Consumer, against claim of Drug Preemption

Opinion just came in today, and it's worth a read:

http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf

Held: Federal law does not pre-empt Levine’s claim that Phenergan’slabel did not contain an adequate warning about the IV-push method of administration.

Footnote 11 is worth your read alone:

11In 1955, the same year that the agency approved Wyeth’s Phener-gan application, an FDA advisory committee issued a report finding“conclusively” that “the budget and staff of the Food and Drug Admini-stration are inadequate to permit the discharge of its existing responsi-bilities for the protection of the American public.” Citizens AdvisoryCommittee on the FDA, Report to the Secretary of Health, Education,and Welfare, H. R. Doc. No. 227, 84th Cong., 1st Sess., 53.

and ...

(“The [FDA] lacks the resources needed to accomplish its large and complex mission . . . .There is widespread agreement that resources for postmarketing drugsafety work are especially inadequate and that resource limitationshave hobbled the agency’s ability to improve and expand this essentialcomponent of its mission”); GAO, Drug Safety: Improvement Needed inFDA’s Postmarket Decision-making and Oversight Process 5 (GAO–06–402, 2006), http://www.gao.gov/new.items/d06402.pdf (“FDA lacks a clear and effective process for making decisions about, and providingmanagement oversight of, postmarket safety issues”);

FDA; 189,000 Food Plants Worldwide; 96 Inspected

No your eyes are not deceiving you. That's the total of plants inspected in 2007 by the FDA. The FDA is broken.

From the AJC.com

The FDA’s inspection record underscores the need for more regular, comprehensive food inspections. But it also speaks to the importance of prevention and transparency, not crisis management, in protecting the safety of our food supply.

An efficient safety network prevents contamination before food products are shipped to schools, senior centers and grocery stores. An efficient system also tracks illness outbreaks quickly and recalls tainted products with equal speed.

Today, the U.S. food-safety network does not meet those standards, and Americans are literally dying as a result.

For more go here to read the posted opinion.

Seroquel Internal E-mails Unsealed

Documents recently unsealed in a U.S. federal court case showed AstraZeneca may have known about the risk of weight gain and diabetes in 2000.

At least one lawyer prosecuting the cases said internal e-mails and other documents showed AstraZeneca officials had evidence of the drug's link to weight gain but used promotions suggesting Seroquel had no effect on weight or could lead to weight loss. Weight gain is a risk factor for development of diabetes.

The drugmaker believes that the Seroquel label has always provided adequate and appropriate information and warnings based on available data.

Source here.