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DRUG RECALL

Chandan AhireBharat SolankiDilshad Shaikh

Jaywant PaiPrathmesh Dixit

Saish kamble

Presented By :

Flow of presentation

1. Introduction to Drug Recall1. Introduction to Drug Recall

3.3.

4. 4.

5.5.

2.2.

6. 6.

7. 7.

Introduction

•  Drug recall removes the affected prescription or over-the-counter drug from the market

•  Generally, a recall must be warranted by the high likelihood that the drug will cause

extremely serious injury or death.

FDA Classification

Category I: The use of, or exposure to, the recalled drug is most likely capable of causing a serious health issue or even death to the consumer.

Category II: The use of, or exposure to, the recalled drug is not likely to cause a serious health issue. At most, it may cause temporary or medically reversible adverse health consequences.

Category III: The use of, or exposure to, the recalled drug is not likely to cause an adverse reaction.

WHY RECALL HAPPENS?

Rare, Unpredictable Problems

More Toxic than Expected

When Safer Options Are Available

Dangerous Combinations

When Other Risk Management Options Fail

How Does a Recall Happen?

Recalls come about in one of three ways.

This is the most common method of recall.

voluntarily recall the drugThe manufacturer initiates the recall.

The FDA orders the manufacturer to recall the drug. If the manufacturer refuses to recall the drug, the FDA can go to court to force the manufacturer to recall the drug or to get legal authority to seize the drug.

voluntarily recall the drugIn this scenario, the FDA informs the manufacturer that its product is defective and suggests or requests that the manufacturer recall the drug.

Which Products ??

FDA-regulated Products Subject to Recall

human drugs

animal drugs

medical devices

radiation-emitting products

vaccines

blood and blood products

transplantable human tissue

animal feed

cosmetics

SOP on Recall

Resposibility :

General Manager/ Vice President : QA/QC and Regulatory

General Manager : Manufacturing

In Case of Adverse Events the committee evaluates the Crisis. It consists of

following Individuals

GM /VP/QA/ QC, Regulatory

GM Manufacturing

GM, Formulation and Development

Medical Advisor

Vice President – Marketing

Vice President – International Marketing

Vice President - Technical Operations

Recall Handling

The main Objective of Recall Plan are

Stop the Distribution and Sale of affected Product

Effectively notify Management, Customers and Regulatory Authority

Efficiently remove the product from Marketplace, Warehouse and

Distribution areas

Dispose and Conduct a root cause analysis and report the effectiveness and

outcome of recall

Implement a corrective action plan to prevent another Recall

Procedure

Any Employee becoming aware of such medicine Immediately notify to higher

authorities

Immediately quarantine existing In-House of relevant medicine

Record the following information :

a. The Product name, Strength, Pack Size, batch No., Mfg and Expiry Date

b. The total no. of units released for sale

c. Date on which distribution commenced

d. Total no. of units distributed

e. No. of units still in stock

f. Nature of reported Violation

In the light of above information higher officials evaluates the health hazard

presented by violated medicine and document it on “ medicine recall control

Document”

Product Recall Chart

Assemble Recall Mgt. Team

Notify Health Agencies

Identify all products to be recalled

Detain & Segregate

Prepare Press Release

Prepare Distribution List

Prepare and Distribute the Notice of recall Contd….

Contd..

Verify the effectiveness of Recall

Control the Recalled Products

Fix the cause of the Recall if problem occurred at QA/QC- Mfg.

Recall Policy

Recall is an effective method of removing or correcting consumer products that are in violation of laws administered by the FDA

Recall may be undertaken voluntarily and at any time by manufacturers, distributors, or at the request of FDA

Recall is generally more appropriate and affords better protection for consumers. Seizure, multiple seizure, or other court action is indicated when a firm refuses to undertake a recall requested by FDA

Recall strategy

1) A recall strategy that takes into account following factors:

i. Results of health hazard evaluation

ii. Ease in Identifying the product.

iii. Degree to which the product deficiency is obvious to the consumer or user

iv. Degree to which the product remains unused in the market place

v. Continued availability of essential products.

Elements of Recall Strategy :

Depth of Recall

Public Warning

Notice of Recalls

There are several ways that the manufacturer and the FDA notify consumers about a recall.

Direct notification. The drug manufacturer must notify its direct accounts (such as wholesalers or chain drug stores) about the recall. The notification must do all of the following:Inform the reseller that the drug has been recalled.Request that the reseller stop distributing the drug.If appropriate, request that the reseller notify its customers about the recall.Instruct the reseller on what to do with the drug.

Public notification. The FDA maintains a list of drug and medical device recalls on its website (www.fda.gov) called Recalls, Market Withdrawals, & Safety Alerts. For the most part, this list includes Class I safety recalls. To find out about Class II and Class III recalls, you can check the FDA's weekly Enforcement Reports, also found on the FDA website.

Media coverage. Often, if a drug recall affects many people, or the recalled drug causes severe injury or death, the media will report on the recall.

Drugs Banned in India

Fenfluramine and dexfenfluramineFenfluramine and dexfenfluramine were used to treat obesity. They were widely used in slimming centers. However, they were withdrawn due to reports of diseases of heart valves, fibrosis of the heart and pulmonary hypertension. The combination of fenfluramine and phenteramine, another weight loss pill was particularly notorious for causing heart valve problems and sudden death.

RimonabantRimonabant was particularly effective in causing weight loss. It inhibited the action of substances called cannabinoids in the brain. It has been withdrawn due to serious side effects like depression, suicidal tendencies and seizures.

SibutramineSibutramine is a weight loss pill that has been recently banned since it caused heart related side effects.

Drugs Banned in India

PhenforminPhenformin is an antidiabetic drug similar to metformin. It has been banned since it carries a high risk of lactic acidosis.

Rofecoxib and valdecoxibRofecoxib and valdecoxib were popular painkillers that were used for arthritis and other painful conditions. They resulted in pain relief without causing gastric side effects. However, they were withdrawn due to concerns of heart attack and stroke with their use.

RosiglitazoneRosiglitazone is a drug used in the treatment of type 2 diabetes. It has been banned due to an increased risk of heart attacks.

GatifloxacinGatifloxacin is an antibiotic whose use as an oral and injectable drug has been recently banned in India. This is due to its risk for severe hyperglycemia or high blood sugar levels in the elderly.

Major Drugs Banned Globaly

Celebrex - an NSAID (non-steroidal anti-inflammatory drug) linked to heart attacks and strokes. In 2004 Pfizer sponsored a study  that halted the use of Celebrex after discovering that "patients taking 400mg to 800mg of Celebrex daily had 2.5 times greater risk of experiencing major heart problems.“

Meridia - the anti-obesity drug that caused, yes, again, heart attacks and strokes. Meridia was manufactured by Abbott Laboratories and recalled after a study, conducted by the New England Journal of Medicine, revealed that, "Meridia increases the risk of heart attack and stroke by 11%, while doing little to assist with weight loss." The FDA  linked almost 20 deaths to Meridia before it was recalled, with 70% being women with an average age of 43.

Vioxx - an anti-arthritis drug linked to heart attacks and strokes. One victim of Vioxx was a marathon runner who dropped dead after taking Vioxx. His case against Vioxx settled for more than $250 million. Vioxx was one of the most widely prescribed drugs in 2003, competing with Celebrex.

Major Drugs Banned Globaly

Yaz - a popular pro-choice method for women was yanked from the market after being linked to stroke, blood clots, DVT, and pulmonary embolism. Yaz and Yasmin, developed and marketed by Bayer HealthCare Pharmaceuticals, were the most common birth control pills on the market before being recalled. Other reported side effects of this birth control  were liver disease, kidney disease, gallbladder disease, and serious organ failure.

Avandia - an anti-diabetes medication that was designed to make cells more responsive to insulin, but increased the risk of heart attack and stroke. GlaxoSmithKline is in the midst of dealing with over 13,000 lawsuits due to Avandia's adverse effects. This drug is still available on the market, but is severely restricted.

List of Drugs Banned Globally Since 2000

Troglitazone (Rezulin) 2000 Withdrawn because of risk of hepatotoxicity; superseded by pioglitazone and rosiglitazone

Alosetron (Lotronex) 2000 Withdrawn because of risk of fatal complications of constipation; reintroduced 2002 on a restricted basis

Phenylpropanolamine (Propagest, Dexatrim) 2000 Withdrawn because of risk of stroke in women under 50 years of age

when taken at high doses (75 mg twice daily) for weight loss.

Cerivastatin (Baycol, Lipobay) 2001 Withdrawn because of risk of rhabdomyolysis

Rapacuronium (Raplon) 2001 Withdrawn in many countries because of risk of fatal bronchospasm

Rofecoxib (Vioxx) 2004 Withdrawn because of risk of myocardial infarction

mixed amphetamine salts (Adderall XR)

2005

Withdrawn in Canada because of risk of stroke. See Health Canada press release. The ban was later lifted because the death rate among those taking Adderall XR was determined to be no greater than those not taking Adderall.

Thioridazine (Melleril) 2005 Withdrawn from U.K. market because of cardiotoxicity

Natalizumab (Tysabri) 2005–2006Voluntarily withdrawn from U.S. market because of risk of Progressive multifocal leukoencephalopathy (PML). Returned to market July, 2006.

Pergolide (Permax) 2007 Voluntarily withdrawn in the U.S. because of the risk of heart valve damage. Still available elsewhere.

Tegaserod (Zelnorm) 2007Withdrawn because of imbalance of cardiovascular ischemic events, including heart attack and stroke. Was available through a restricted access program until April 2008.

Aprotinin (Trasylol) 2007 Withdrawn because of increased risk of complications or death; permanently withdrawn in 2008 except for research use

Inhaled insulin (Exubera) 2007 Withdrawn in the UK due to poor sales caused by national restrictions on prescribing, doubts over long term safety and too high a cost

Lumiracoxib (Prexige) 2007–2008 Progressively withdrawn around the world because of serious side effects, mainly liver damage

Rimonabant (Acomplia) 2008 Withdrawn around the world because of risk of severe depression and suicide

Efalizumab (Raptiva) 2009 Withdrawn because of increased risk of progressive multifocal leukoencephalopathy; to be completely withdrawn from market by June 2009

Sibutramine (Reductil/Meridia) 2010 Withdrawn in Europe, Australasia, Canada, and the U.S. because of increased cardiovascular risk

Gemtuzumab ozogamicin (Mylotarg) 2010Withdrawn in the U.S. due to increased risks of veno-occlusive disease and based on results of a clinical trial in which it showed no benefit in acute myeloid leukemia (AML)

Rosiglitazone (Avandia) 2010 Withdrawn in Europe because of increased risk of heart attacks and death. This drug continues to be available in the U.S.

Drotrecogin alfa (Xigris) 2011Withdrawn by Lily worldwide following results of the PROWESS-SHOCK study that showed lack of efficacy (not because of toxicity like other drugs that have been withdrawn).

List of Drugs Banned Globally Since 2000

Black Box Warnings

A black box warning is the strongest warning for any prescription drug.

Is a specific warning that is placed on a prescription drug package insert when it is determined that the prescription medication may cause serious adverse side effects

 The black box warning is so named for the black border that typically highlights the warning label.

Black Box Warning for CIPRO®

As of 2011 the FDA has added two black box warnings

WARNING: Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis

Black Box Warnings

On the basis of reports provided by U.S FDA

Medical studies indicate that a prescription drug has significant risk of serious injury or life-threatening adverse effects

Already marketed drugs - issues pertaining to its safety or related side effects sometimes emerge

Clinical research or, more commonly, through adverse events reported by consumers or physicians

Black Box Warnings

The FDA has two options:

1) It can choose to completely remove the drug from the market in a drug recall, or,

2) The FDA can issue an advisory or warning, (Black box warning) that appears on the drug's printed materials, both inside the packaging and on materials developed for the doctors who may prescribe the drug.

Effect on Prescription

Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns. 

In 2005, the FDA issued a boxed warning regarding the risk of atypical antipsychotics being prescribed among elderly patients with dementia - decrease in use of antipsychotics, especially in elderly patients with dementia

It is not necessary that physicians would discuss with patients An FDA-mandated boxed warning decreased rosiglitazone use by 70%, but

still 3.8 million people were given the drug

But Pioglitazone with similar warnings did not decrease in use

Reference

www.fda.gov.in

http://www.nolo.com/legal-encyclopedia/fda-drug

http://www.drugrecalls.com