Drug Injury Watch

FDA and Health Canada Issue Warnings For Antibiotic Tequin

Advising Diabetic Patients Not To Use Tequin Due To Concerns About Blood Sugar Disorders

In mid-February 2006 the FDA and Health Canada issued separate alerts regarding the threat of rare but potentially fatal side effects associated with use of the antibiotic Tequin (gatifloxacin).  According to both agencies, Bristol-Myers Squibb Co. will put stronger warnings on the label, or package insert, about serious cases of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) in patients receiving Tequin. 

Tequin is an antibiotic approved for the treatment of pneumonia, bronchitis, and other infections. According to the FDA MedWatch alert, "[s]ince the approval of Tequin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with [Tequin]."   Warnings about the risk of low and high blood sugar were added to the Tequin label by Bristol-Myers in 2002.  The new, stronger warning will provide additional information concerning the types of patients that are more likely to have the blood-sugar problems.

In a February 15, 2006 "Dear Doctor" letter regarding Tequin, Bristol-Myers said the label changes point out the risk factors for developing hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar); these risk factors include:

• advanced age;
• renal insufficiency; and,
• concomitant glucose-altering medications while taking Tequin.

The Health Canada alert regarding Tequin advises diabetic patients, as a precaution, not to use this antibiotic due to concerns about these blood sugar disorders.

(Posted by: Tom Lamb)

Adderall and Ritalin: With Heart Risks Uncertain, What Should Patients Do?

Some Medical Advice About ADHD/ADD Drugs From Cardiologists And Psychiatrists

In mid-February 2006 came the news that an advisory panel of drug-safety experts recommended a "black-box" warning for Adderall, Ritalin, and the other ADHD/ADD drugs -- and that the FDA was not going to act on this advice, at least for the time being.  This situation left many people understandably confused.

To address some of these concerns and questions, New York Times (NYT) reporter Benedict Carey interviewed some prominent cardiologists and psychiatrists (free registration required) for an article which was published on February 21, 2006.  Mr. Carey's apparent aim was to provide some guidance to adult patients and the parents of pediatric patients in terms of how to proceed in view of the possible serious side effects associated with Adderall, Ritalin, and the other ADHD/ADD drugs.  Here is a summary of his findings.

Primarily, it is people with high blood pressure, heart murmurs, or other cardiovascular problems who should be consulting with their doctors in order to determine whether Adderall, Ritalin, or some other ADHD/ADD drug is safe for them. 

Along these line, concerning pediatric patients, Mr. Carey reports:

Some panel members expressed concerns about children with structural heart abnormalities who might be given stimulants. Perhaps the most common abnormality is hypertrophic obstructive cardiomyopathy, a thickening of the muscle that can cause a blockage — and death — when under stress.

Such problems are often not diagnosed before drug treatment begins, but a good pediatrician who is aware a child is being considered for stimulant treatment will often pick up a soft heart murmur that might reflect an abnormality, said Dr. Steven Nissen, chief of cardiology at the Cleveland Clinic and a panel member. "This seemingly small step could save a life," he said.

As for adult patients using Adderall or Ritalin, the emphasis is on one's blood pressure. From Mr. Carey's February 21 NYT article:

The biggest worry for adults is high blood pressure. Stimulants usually prompt slight increases in heart rate and raise blood pressure, and even these changes can increase the risk of heart problems in someone who is vulnerable, Dr. Nissen said.

"A smoker with high cholesterol and a family history of heart disease: that's a person I would be very concerned about taking stimulants," Dr. Nissen said.

From his interviews, Mr. Carey found that, generally, there are a few screening questions which would help a doctor determine whether or not Adderall or Ritalin is safe for a patient.

• Are there any congenital or structural heart defects?
• Are there unexplained bouts of dizziness or heart palpitations?
• Is there any family history of heart disease, in particular sudden deaths in close relatives who died young?

It seems advisable that doctors should be these few questions, at least, before prescribing Adderall, Ritalin, or another ADHD/ADD medication.  If your doctor, or your child's doctor, is considering such treatments but has not asked, you should "volunteer" this part of your medical history for their decision-making.

(Posted by: Tom Lamb)

Study Shows Blood-Clot Risk For Birth Control Patch Is Double That Of An Oral Contraceptive

However, According To Another Study Ortho Evra Skin Patch Use Presents No Increased Risk Of Blood Clots

On February 16, 2006 Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson (J&J) unit, announced that some preliminary results from a yet-to-be-published study indicate there is a two-fold increase in the risk of blood clots among users of its Ortho Evra birth control patch when compared to women using a typical birth control pill.  At the same time, Ortho-McNeil pointed out the results from a second Ortho Evra study, this one just published on the Web site of the journal Contraception, which showed there was no increased risk of blood clots when Ortho Evra was compared to birth control pills.

As background, in November 2005 the FDA issued a MedWatch Alert telling doctors and patients that the contraceptive patch Ortho Evra might increase the risk of blood clots because the patch contains more estrogen than a typical birth control pill.  Specifically, the FDA said women using the Ortho Evra birth control patch are exposed to about 60% more estrogen than if they were taking a birth control pill with the typical 35 micrograms of estrogen. It is the exposure to this higher level of estrogen exposure from the Ortho Evra patch that could significantly increase a woman's risk of developing potentially fatal blood clots.

After the November 2005 FDA alert about Ortho Evra, Ortho-McNeil and J&J said they would conduct additional safety studies on the issue of whether Ortho Evra causes an increased risk of blood clots which, in turn, can produce heart attacks and strokes.  The two studies which were announced by the drug companies on February 16, 2006 are part of their effort on that front.

The first Ortho Evra study (not published yet) is being conducted by a unit of Ingenix, which is part of UnitedHealth Group.  According to a February 16, 2006 article in The Wall Street Journal (subscription required), by reporter Jennifer Corbett Dooren:

"[This Ortho Evra study] showed a two-fold increase in the risk of blood clots, or venous thromboembolic events, compared to women on a regular birth control pill. The same data does not show an increase in the risk of heart attacks and strokes, J&J said."

Then there is the second study, published online by the journal Contraception, where researchers examined a medical records database for 200,000 women.  Those researchers found that the risk of developing blood clots among Ortho Evra users was about the same as the risk among women using a typical birth control pill.

The heart attack and stroke risk aspect of this second study is still ongoing, Ortho-McNeil said in their February 16 statement, which added "the currently available data do not show an increase in the risk of the combined endpoint of heart attack and stroke."

A day after the Ortho-McNeil / J&J announcement about these Ortho Evra studies, the FDA said further investigation of the issue of whether Ortho Evra causes an increase in blood clots is warranted.  As Reuters reported on February 17, 2006, however, Dr. Daniel Shames, director of the FDA's division of reproductive and urologic drug products, made clear that the FDA does not plan to take any action at present based on these two Ortho Evra studies.

As of early 2006, it is estimated that the Ortho Evra birth control patch has been used by more than 5 million women since it was approved by the FDA in 2002. 

(Posted by: Tom Lamb)

Adderall Safety Is Not Proven By Health Canada's Decision To Reverse Ban On ADHD Drug

A Closer Look At How (Or Why) Adderall Got Back On The Market In Canada

In the October 7, 2005 edition of Psychiatric News there was an article by Jim Rosack entitled "Canada Reverses Ban On ADHD Medication" that examined how Adderall XR got back on the market six months after Health Canada had suspended sales of the popular attention-deficit/hyperactivity disorder (ADHD) drug.

As background, Health Canada announced on August 24, 2005 that Adderall XR could be reintroduced to the Canadian market.  Health Canada had recalled Adderall XR from the Canadian market in February 2005 after learning from Shire Pharmaceuticals Group Plc -- the company responsible for Adderall XR in Canada -- about 20 cases of sudden death and 12 cases of stroke in people using the ADHD drug.

An article published in the October 11, 2005 edition of the Canadian Medical Association Journal pointed out that Health Canada decided to allow Adderall back on the market in August 2005 not because the agency found Adderall to be safe but, rather, because "an independent panel found it impossible to accurately ascertain whether the drug increases the risk of cardiac death."

Given the February 2006 recommendation by an FDA advisory panel committee that a "black-box" warning be put Adderall and the other ADHD drugs, the "how-and-why" of Adderall getting back on pharmacy shelves in Canada is worth a second look. 

Health Canada rescinded its suspension order and allowed Adderall to return to the market after its committee of outside medical experts, called the Adderall XR New Drug Committee, had concluded that "an increased risk of sudden cardiac death and/or stroke with Adderall XR compared to alternate active treatments has not been proven."

It is important to know that the Health Canada committee concluded, also, that "such an increase [in risk of sudden cardiac death associated specifically with Adderall XR use] has not been ruled out due to limitations in the data currently available for analysis"  (emphasis added).

Faced with this predicament, the committee recommended several steps be taken by Health Canada and Shire before Adderall was put back on pharmacy shelves.  The full set of recommendations can be found in the report prepared by this Adderall XR New Drug Committee.  In his October 2005 Psychiatric News article, Rosack provides some of the highlights:

• recommended that Health Canada seek expert consultation "on the appropriateness of potential additional cautions (e.g., strenuous exercise, use of other stimulants, family history of sudden cardiac death) in patients treated with any ADHD drug (stimulant or non-stimulant) that might be considered in the assessment of benefit versus risk for an individual patient."
• recommended that Health Canada approve revised product labeling submitted by Shire in November 2004. That proposed labeling (virtually identical to the approved labeling in the United States) includes warnings regarding reports of sudden death in patients taking therapeutic doses of amphetamines, particularly children with structural cardiac abnormalities. The new Canadian labeling will also add myocardial infarction, sudden death, and stroke to the list of potential adverse events.
• recommended that Health Canada "enhance postmarketing surveillance for all stimulant drugs used in the management of ADHD," but did not list specific steps they thought should be taken. The committee also noted that while an increased risk of adverse cardiac events associated with stimulant medications "is lacking, even in the absence of this information, it may still be prudent for a baseline EKG be obtained prior to implementing drug therapy" for patients who are involved in strenuous exercise, use more than one stimulant medication, or have a family history of sudden cardiac death.

In the end, despite the fact that Health Canada let Adderall XR back on the market, it seems that there are some serious and yet unresolved safety issues for this ADHD drug.  As such, the FDA should give more consideration to the findings of its own advisory panel committee and, in particular, the recommendation that a black-box warning be added to Adderall and the other ADHD drugs.

(Posted by: Tom Lamb)

"Black-box" Warnings Are Forgotten Or Ignored By Some Doctors

The So-called Black Box Is FDA's Highest Form Of Drug Safety Alert

In the February 14, 2006 edition of the medical journal Archives of Internal Medicine there is a report that many patients are told by their doctors to use prescription drugs with "black-box" warnings in situations contrary to the drug-safety information and guidance set forth in those warnings.

Black-box warnings are the highest form of drug safety alert and, because of their importance, usually appear at the top of a drug's package insert, or label.  Typically the black-box warning brings attention to serious side effects associated with the drug, and provides guidance about how to minimize the risks of those side effects -- such as to not prescribe a particular drug with another drug, or to patients with certain pre-existing medical conditions.

In this study report published by the Archives of Internal Medicine, researchers examined the health records of 324,548 outpatients seen at several Boston-area medical clinics from January 1, 2002 to December 31, 2002.  The researchers found that 33,778 patients were prescribed a medication that had a black-box warning; of those, 2,354 prescriptions were contrary to the guidance set forth in the subject black-box warning.

In about 1,000 cases, the patients were simultaneously taking one or more drugs that the black-box warning said should be avoided so as to prevent a possible drug-drug interaction.  It is presumed that in most of those situations the black-box warning was forgotten by the prescribing doctor.

Interestingly, most of the instances which involved a black-box drug, about 90%, also involved prescribing the black-box drug to treat a disease or medical condition for which use of that drug was not even approved by the FDA. This type of prescribing is commonly referred to as "off-label" use.  In some of those cases, just as the doctor decided to use his or her own discretion as opposed to relying on the FDA-approved use, it is presumed that the prescribing doctor may have purposely chosen to ignore a black-box warning.

While this study found that the number of patients who received a black-box drug in a situation contrary to the substance of the black-box warning is relatively small, i.e., compared with the total number of outpatient prescriptions examined for the study, according to the researchers "the absolute number of outpatients at risk is substantial."

As always, we urge patients to know about the serious side effects, and the symptoms thereof, which are associated with any prescription drug they are taking.  To that end, we provide this listing of side effects and drug interactions for reference.

(Posted by: Tom Lamb)

Advisory Panel Wants "Black-box" Warning For Adderall, Ritalin, ADHD/ADD Drugs; FDA Balks

Drug-safety Experts And Top FDA Officials Disagree About Increased Heart Risks Associated With Stimulants

On February 9-10, 2006 the FDA convened an advisory panel committee of outside drug-safety experts to consider the issue of how best to study the potential cardiac risks of Adderall, Ritalin, and other stimulants.  This advisory panel committee, however, went beyond their assigned mission and recommended that a "black-box" warning be put on Adderall, Ritalin, and other drugs used to treat attention deficit hyperactivity disorder (hereafter, "ADHD/ADD drugs"). 

This FDA advisory panel committee apparently wanted patients and their parents to know now what is going on with the ADHD/ADD drug issue, recommending this black-box warning be added to the labels while the manufacturers are investigating whether their drugs increase one's risk of having a heart attack or stroke.

A day before this panel met the FDA disclosed findings from its review of several ADHD/ADD drugs; from 1999 to 2003 there were 81 deaths and 54 non-fatal cardiovascular events, like heart attacks and strokes, reported to the FDA MedWatch program which were possibly linked to the ADHD/ADD drugs.  These adverse event reports made to the FDA included incidents involving Shire Pharmaceuticals PLC's Adderall, Johnson & Johnson's Concerta, Novartis AG's Ritalin, and some similar generic drugs.

In a memo to advisory panel committee members from Gerald Dal Pan, the FDA's director of the Office of Drug Safety, it was pointed out that the MedWatch reports of deaths and other cardiovascular events associated with Adderall and other ADHD/ADD drugs "do not establish a causal link between the medications" and the events because the sudden cardiac death, or heart attack, or stroke, could have occurred for another reason.

According to a February 8, 2006 article published by Reuters, Adderall was involved in more fatal case reports than any other ADHD/ADD drug.

"Through 2003, 24 deaths were reported from 1999 through 2003 among U.S. patients who took Adderall for ADHD....  Another 16 deaths were reported through 2003 in U.S. patients who took Ritalin or other ADHD drugs known as methylphenidates, the report said. Eleven deaths were reported among other drugs besides Adderall in the amphetamine class, it said."

The degree of disagreement between drug-safety experts and top FDA officials about increased heart risks associated with these stimulants is made clear by Gardiner Harris in his February 10, 2006 New York Times article concerning the outcome of this advisory panel committee meeting: (free registration required)

• "The committee's action was unexpected. The Food and Drug Administration had convened the panel to help it determine how to research possible heart risks of the drugs. The agency had not asked the committee to address the drugs' labels, and agency officials seemed taken aback by the votes, saying they would not act on the committee's recommendations anytime soon."
• "'We don't think anything different needs to be done right now,' Dr. Thomas Laughren, director of the Division of Psychiatry Products at the agency, said at a hastily arranged news conference after the meeting. 'We think the labeling right now is adequate.'"
• "Dr. Andrew Mosholder, also a medical officer in the Office of Drug Safety, said he reviewed the chemical structures of stimulants, and he noted that these structures were similar to drugs like ephedrine that had proven heart risks."
• "Arthur A. Levin, director of the Center for Medical Consumers in New York City and member of advisory panel... 'For us to sit around and talk about it, and for us to not make a very strong warning about the uncertainty of these drugs and their possible risks, would be unethical,' Mr. Levin said."
• "Dr. Thomas R. Fleming, a professor of biostatistics at the University of Washington and a panel member, said stimulants might be far more dangerous to the heart than Vioxx or Bextra, drugs that were withdrawn over the past two years because of their ill effects on the heart."

Health Canada temporarily suspended Adderall sales last year after 20 reports of sudden death in people who took it. The agency allowed Adderall back on the market after Health Canada concluded that it could not prove that Addrerall was more risky than other ADHD/ADD drugs.

ADHD is a neurological disorder in which people have difficulty concentrating or staying on a task to the extent that it causes impairment in academic, work, or social settings. Up to 7% of U.S. school-age children are believed to have ADHD. The disorder is often referred to as attention deficit disorder, or ADD, in adults.

During 1999 to 2003 (same five-year time frame as FDA's review), about 78 million prescriptions were written for ADHD/ADD drugs in children ages one to 18, and more than 14 million ADHD/ADD drug prescriptions were written for adults.

(Posted by: Tom Lamb)

Health Canada Warning: Possible Link Between Ketek And Liver Failure

Reports Of Hepatitis And Serious Liver Problems Involving Ketek Use

On February 7, 2006 Health Canada issued a Warning about the antibiotic Ketek and its possible association with potentially serious liver problems.

According to Health Canada's Warning on Ketek (telithromycin), there have been international reports of patients using Ketek who experienced drug-induced hepatitis and liver failure.  As of the time that the February 2006 Ketek Warning was issued, however, no such cases had been reported to Health Canada.

Ketek has been marketed in Canada since May 2003, when this antibiotic was approved for the following uses:

• the treatment of pneumonia
• the treatment of throat and sinus infections and chronic bronchitis
• the treatment of serious or multi-drug resistant infections

The safety concerns about Ketek expressed by Health Canada, as well as the European Union's EMEA, began in late January 2006 with the online "early" release of an article about Ketek that will be published in the March 21, 2006 edition of the Annals of Internal Medicine.  This article reported three cases in a North Carolina hospital where there was liver failure associated with Ketek use.

In their Ketek Warning, Health Canada made the following "interim recommendations" to doctors and patients:

"Ketek should not be used for patients who have pre-existing liver problems."

"Patients taking Ketek should contact their health care provider immediately if they notice yellowing of their eyes or skin, or experience any other symptoms of liver problems, such as blurry vision, loss of appetite, dark urine, pale stools, itching or abdominal pain."

"Patients who have been prescribed Ketek and are not suffering side effects such as those described should continue taking their medicine, unless otherwise directed by their health care provider."

Health Canada concluded by stating that it would issue another advisory about Ketek "if further precautionary measures are necessary".

(Posted by: Tom Lamb)

Ortho Evra Birth Control Patch Linked To Increased Risk of Serious Blood Clots

2005 Label Change Warns About Higher Levels Of Estrogen Found In Ortho Evra

In July 2005 the Associated Press (AP) published an investigative article that linked the birth control patch Ortho Evra to an increased risk of blood clots and deaths -- compared to older contraceptives -- in some young healthy women.

In November 2005 the FDA announced that it had approved an updated label, or package insert, for the Ortho Evra contraceptive patch.  This label change was intended to warn doctors and patients that the Ortho Evra birth control patch exposes women to higher levels of estrogen than a typical birth control pill. It is the higher levels of estrogen which women using the Ortho Evra skin patch are exposed to that causes the increased risk of developing blood clots and other serious side effects.

The AP's July 2005 article on Ortho Evra said that a review of adverse drug reaction reports for Ortho Evra revealed that 17 of the 23 death cases appeared to be related to blood clots.  The AP article stated that there were 12 deaths of Ortho Evra users reported to the FDA in 2004.  The actual number of deaths due to blood clots in Ortho Evra users, however, is probably much higher because the FDA estimates that the agency receives reports for only a small percentage -- in the range of 1% (1 out of 100) to 10% (1 out of 10) -- of the serious adverse drug reactions that actually occur in the U.S.

Ortho Evra was approved by the FDA in November 2001 and is the first contraceptive product to be approved for use is the U.S. as a skin patch. Ortho Evra is sold by Ortho-McNeil Pharmaceuticals, Inc. of Raritan, N.J.

By examining documents related to FDA reviews of clinical trial results submitted by Ortho-McNeil in support of Ortho-Evra, the AP found that the safety of Ortho Evra was disputed even before it was approved by the FDA in 2001.  The AP reported that the FDA medical officer reviewing the Ortho Evra application disagreed with Ortho-McNeil about whether or not two cases of blood clots in the lungs (pulmonary embolus) in young women participating in the pre-approval clinical trials were caused by the Ortho Evra. In relevant part, the FDA medical officer wrote:

"THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S [Ortho-McNeil] ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases in the ... group [emphasis in the original]."

As concerns the increased risk of developing blood clots associated with Ortho Evra, it is generally advised that women using the Ortho Evra birth control patch should contact their physician if any of the following warning signals develop:

• Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung)
• Pain in the calf (indicating a possible clot in the leg)
• Crushing chest pain or tightness in the chest (indicating a possible heart attack)
• Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)
• Sudden partial or complete loss of vision (indicating a possible clot in the eye)

Lastly, like the other hormonal contraceptives, Ortho Evra has a "black-box" warning about the fact that cigarette smoking increases the risk of serious cardiovascular side effects. This risk increases with age and with heavy smoking (15 or more cigarettes per day).  Women over 35 years of age who use hormonal contraceptives, including Ortho Evra, especially should be strongly urged not to smoke.

(Posted by: Tom Lamb)

February 2006 FDA "Patient Safety News" Videos For Doctors Online

Edition Covers Alpha-1 Blockers, Amevive, Salagen - Selegiline Name Confusion, and More

The FDA's Patient Safety News (PSN) is a series of monthly video news shows intended primarily for doctors and other health care professionals.  Generally, this series covers significant approvals, recalls, and safety alerts for prescription drugs and medical devices.  Some of the FDA PSN videos contain footage and demonstrations relevant to protecting patients from serious side effects and other unwanted consequences.

Subjects covered in the February 2006 edition of the FDA Patient Safety News include the following:

First Donor Screening Test for West Nile Virus

Preventing Hemolysis with Meridian Hemodialysis Blood Tubing

Bacterial Contamination of Vapotherm Devices

Avoiding Glucose Monitoring Errors in Patients Receiving Other Sugars

Recall of Boston Scientific Vena Cava Filters

Alpha-1 Blockers and Cataract Surgery Procedures

Amevive Contraindicated in HIV Patients

Reporting Adverse Events for Drugs, Devices, Biologics and Dietary Supplements

Drug Name Confusion: Salagen and Selegiline

One can find more information about this February 2006 PSN edition and the series in general on the PSN section of the FDA's web site.   

(Posted by: Tom Lamb)

Critics Say FDA Drug-safety Oversight Needs To Be More Independent

Big Pharma Tells IOM Panel, However, No Major Changes Are Needed

In the January 12, 2006 edition of the New England Journal of Medicine (NEJM), an article by Wayne A. Ray and C. Michael Stein calls for Congress to establish more independence and authority as concerns FDA drug-safety oversight so as to better protect patient from the risks of serious prescription drug side effects. Ray is a professor of Preventive Medicine at Vanderbilt University, and Stein is associate professor of Medicine and Pharmacology at Vanderbilt. 

In their NEJM article, "Reform of Drug Regulation -- Beyond an Independent Drug-Safety Board"  (subscription required),  Wayne Ray and Michael Stein assert that the FDA should have independent offices for (1) the approval of a new prescription drug for sale and (2) the monitoring of that drug's safety profile after approval.  The authors also suggest that a new FDA office -- the Center for Drug Information -- should be created to provide doctors with emerging information about drug risks, and promptly issue drug-safety warnings when necessary.  From the NEJM article:

We thus propose a reformed regulatory authority with three distinct functions (Table 2): new-drug approval, post-marketing studies, and drug information. We envision three independent but cooperative centers within a unified agency, although other administrative structures are possible. The new centers would be funded by a tax on pharmaceutical sales. For the reforms to work, the centers must be provided with adequate statutory authority, sufficient funding, and protection from inappropriate political pressure.

In addition, on January 17, 2006 Wayne Ray presented these points to an Institute of Medicine (IOM) panel, which was asked by the FDA to evaluate the agency's drug-safety oversight and recommend changes.  The FDA requested this IOM evaluation last year after the agency was criticized for being slow to act as regards the Vioxx debacle as well as safety problems with some other prescription drugs. 

In advance of his IOM testimony, in an interview with Kerry Young, of Bloomberg News, Wayne Ray pointed out that patients are largely unaware of how little authority the FDA has to update prescribing information given to doctors on drugs.

A recent example of this situation is how two drug companies effectively delayed for a year having to put the "black-box" warning on Elidel and Protopic about increased cancer risks that the FDA wanted placed on the package insert, or label, of those skin ointments.

On the other side of things, according to a January 19, 2006 article by Lisa Richwine, of Reuters, representatives of the drug companies told the IOM panel that while there may be room for some improvement, there is no need for any major change at the FDA.

• "Drug safety in the U.S. definitely needs improvement. It needs a careful, focused treatment, but I would argue not radical exploratory surgery," said Geoffrey Levitt, chief counsel for regulatory and research at Wyeth.
• "We think that moving oversight of safety to another federal agency seems extreme and could significantly stall incremental progress," said James Nickas, senior director of development at Genentech Inc.

This IOM panel regarding drug-safety oversight in the U.S. is scheduled to release a report in mid-2006 with any recommendations it has for changes at the FDA.

(Posted by: Tom Lamb)