Los Angeles Personal Injury Lawyer - FDA & Prescription Drugs - Most Commented

Will the FDA Recall Birth Control Products Yasmin & Ocella?

Paul Kiesel — Tue, 25 Aug 2009 18:29:18 GMT

After a birth control pill spent months in the spotlight during commercials aimed at correcting misrepresentations about it, the pill is now at the center of a St. Clair County lawsuit.

Kerry Sims filed a lawsuit Aug. 18 against Bayer and Walgreens, alleging her ingestion of the birth control pill Yasmin, which is also known as Yaz, caused her to experience a blood clot in her lung and infection surrounding the clot.

The suit comes after a commercial warning of some fallacies about the pill repeatedly ran on television for months.

"You may have seen some Yaz commercials recently that were not clear," the ad says. "The FDA wants us to correct a few points in those ads."

It goes on to say Yaz is used to treat the less serious premenstrual dysphoric disorder and moderate acne, not the more serious premenstrual syndrome or mild acne as Bayer once advertised.

But the $20 million Bayer spent on the commercial is not enough for Sims, who says the company failed to warn her about the pill's dangers before she started taking it.

"Plaintiff Kerry Sims reasonably relied upon Defendants' representations to her and/or her healthcare providers that Yaz/Yasmin was safer than other types of oral contraceptives for human consumption and/or use and that Defendants' labeling, advertisements and promotions fully described all known risks of the product," Sims's suit states.

However, such representations were misleading, Sims claims.

In fact, from 2004 through 2008, Yaz has reportedly caused more than 50 deaths, which occurred in some women as young as 17, the complaint says.

"These reports include deaths associated with cardiac arrhythmia, cardiac arrest, intracardiac thrombus, pulmonary embolism, and stroke in women in their child bearing years," the suit states.

The pill's danger possibly stems from Bayer's use of drospirenone, a new type of progestin only used in Yaz and its generic counterpart, Ocella, according to the complaint. The drospierenone causes increased levels of potassium in the blood, which can lead to a condition called hyperkalemia if potassium levels become too high, Sims claims.

In turn, hyperkalemia can cause heart rhythm disturbances, which can then cause the slowing of blood to the heart, allowing for the formation of blood clots. Those clots can lead to heart attacks or can break off and travel to the lungs, causing pulmonary embolism, which is the condition Sims suffered from. In another scenario, the blood clot can travel to the brain where it can cause a stroke, according to the complaint.

Click here for the rest of the article.

Originally posted at InjuryBoard by Paul Kiesel

Rite Aid Warning Customers About Ethex Drug Recall

Paul Kiesel — Thu, 20 Nov 2008 15:35:00 GMT

Rite Aid customers should be receiving a letter this week, informing them that a major drug manufacturer, Ethex (a subsidiary of KV Pharmaceutical), has issued a recall of several of its generic products, including Morphine Sulfate.

Ethex sent out oversized tablets -- some double the expected dosage -- of over 10 of its prescription medicine. The recall includes a stimulant, morphine (Morphine Sulfate) and couple of Ethex heart medication products.

In Boise, Idaho, some customers have already received the letter from Rite Aid warning them to cease taking these prescriptions and to return the product to a Rite Aid pharmacy. Mark Phillips, an assistant pharmacy director at Boise's Saint Alphonsus, said that taking a double-dose of any of the recalled products can lead to serious effects, even death.

KBCI, a local Boise news station, reported that a Rite Aid spokeswoman said the company has pulled all the affected prescriptions from their shelves. They have also sent a letter to everyone who has filled a prescription for the drugs in the last 12 months, even if they may not be affected by the recall.

Below is the press release sent out by Ethex on November 7, 2008. Anyone who has taken Ethex's Morphine Sulfate or other drugs affected by the recall and would like to know what their options and rights are as a consumer should get in touch with Mr. Paul R. Kiesel or Ms. Helen Zukin at 310-854-4444:

ETHEX Corporation announced today that it has voluntarily recalled to the consumer level specific lots of five generic/non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs.

Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure.

The lots involved in the recall were all shipped prior to May 22, 2008 and are as follows:

Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011

Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011

Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011

Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009

Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009

Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010

Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011

Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011

Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011

The 150 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "331" with a bisect on the reverse. The 225 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "332" with a bisect on the reverse. The 300 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "333" with a bisect on the reverse.

The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval, reddish-pink, film-coated tablet with a debossed "E" bisecting "30" on one side and bisect on the other side. The 60 mg Isosorbide Mononitrate Extended Release Tablet is an oval, yellow film-coated tablet with a debossed "E" bisect "60" on one side and bisect on the other side.

The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet with "15" on one side and an "E" on the reverse. The 15 mg Morphine Sulfate Immediate Release Tablet is a round brown tablet with a "15" on one side and an "ETH" on the reverse. The 30 mg Morphine Sulfate Immediate Release Tablet is a capsule shaped brown tablet with "30" on one side and an "ETHEX" on the reverse.

The 10 mg Dextroamphetamine Sulfate Tablet is a round, flat-face, bevel edge, orange mottled tablet debossed "ETHEX" and "312" on one side and double-scored on the other side.

ETHEX Corporation has initiated recall notifications to wholesalers and retailers who have received any inventory of the recalled product lots with instructions for returning the recalled products. The notification also includes instructions for the retailers/pharmacies to contact consumers who were dispensed these drugs for replacement of the product and/or refund. If the wholesalers and retailers have not already done so, they are urged to contact the number below regarding procedures for returning the recalled products. If consumers have any questions about the recall, they should call the number listed below for customer inquiries, their physician, their pharmacist or other health care provider.

Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8:00 am to 5:00 pm Central Standard Time (CST).

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Any adverse reactions experienced with the use of these products, and/or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Originally posted at InjuryBoard by Paul Kiesel

Yaz: Riskier than Other Birth Control Pills?

Paul Kiesel — Thu, 22 Oct 2009 17:53:50 GMT

Here's another sad story about woman from the Bay Area that suffered from a stroke and, subsequently, was in a comma and then hospitalized for six months, after only taking Yaz for a month for menstrual pains, as prescribed by her doctor.

In 2007, Susan Galinis was the happy mother of 3-year-old twins. She wanted to have more children, so when her doctor said she could either have a hysterectomy or take the Yaz birth control pill to control her menstrual pain, she opted for the pill.

Four weeks and one day after starting it, she had a stroke. Surgeons removed part of her skull to accommodate the brain swelling. She lived, but she's not the same.

"My IQ has plummeted to 77, which I guess is borderline mentally retarded, from the stroke, from the brain damage, that's what they say it is," says Galinis.

Galinis was in the hospital for six months. She now has chronic pain and no short-term memory. She cannot drive. Her twins have had to adjust with the help of a counselor.

"She says basically to them their mom did die because she was there one day and the next day she was gone. I was gone for basically six months and then I came home with a different voice, a different personality," says Galinis.

Galinis says her doctors told her it was Yaz that caused the stroke. All birth control pills carry increased risk of stroke, but Galinis' lawyer Mike Danko says studies show it has twice the risk as other pills. On Monday, they filed suit against Yaz manufacturer Bayer.

Click here for the rest of the article.

**Also, anyone who has been adversely affected due to taking these prescription drugs should get in touch with Helen Zukin. Ms. Zukin recently retained a client, a young woman, who unfortunately suffered from a stroke, after only taking Ocella (generic version of Yaz) for a month.

Originally posted at InjuryBoard by Paul Kiesel

FDA: Stop Using Hydroxycut Dietary Supplements Immediately

Paul Kiesel — Fri, 01 May 2009 14:56:45 GMT

From the Los Angeles Times:

Booster Shots Blog

by Jeannine Stein

The Food and Drug Administration has issued a warning to consumers to stop using Hydroxycut dietary supplements because some have been linked to serious liver injuries, with one death reported to the agency.

Iovate Health Sciences Inc. is recalling its Hydroxycut products from the market. The popular, heavily advertised supplements promise weight loss and include such products as Max Drink Packets, Caffeine-free Rapid Release Caplets, and Max Aqua Shed. Not part of the recall are Hydroxycut Cleanse and Hoodia products. The recalled products contain several ingredients, among them herbal extracts, although the FDA said it’s not sure which ingredients or dosages could be causing the problems. Unused products should be returned to where they were purchased.

In all, one death due to liver failure was reported to the FDA, plus 23 instances of severe health problems including jaundice, elevated liver enzymes, liver damage (requiring a liver transplant), seizures and cardiovascular disorders. Liver injury symptoms include jaundice, brown urine, excessive fatigue, stomach or abdominal pain, and nausea.

Although the FDA says that bad reactions are rare, anyone using the products should stop immediately. Dr. Linda Katz, the interim chief medical officer of the agency's Center for Food Safety and Applied Nutrition, said those experiencing symptoms should check with their doctor.

More information:

*FDA Hydroxycut Recall Page

**Other articles on Hydroxycut Recall

Originally posted at InjuryBoard by Paul Kiesel

Trader Joe's Expands Its Peanut Butter Recall

Paul Kiesel — Wed, 11 Feb 2009 20:02:29 GMT

The Associated Press has released a new list of companies that are expanding their peanut butter (and applicable products) recall efforts.

Southern California residents who purchased Vegan Trail Mix Cookies, SKU 22442, from any Trader Joe's store need to be aware that the product could contain the Salmonella virus seen in other peanut products affected by the recall.

Trader Joe's is expanding its recall of select private label products because they COULD be contaminated with salmonella. No illness has been reported. Details: by phone at 626-599-3817.

Below is the rest of Trader Joe's expanded peanut butter recall:

_ Peanut butter and chocolate chip cookies; sold in the Midwest, Georgia and Nashville, Tenn.; 12 ounces; SKU 80871.

_ Vegan trail mix cookies; sold in Southern California, Arizona, New Mexico and Nevada; 12 ounces; SKU 22442.

_ Frozen gluten-free peanut butter cookie dough; sold nationwide; 15.3 ounces; SKU 91167.

Originally posted at InjuryBoard by Paul Kiesel

Who's Still Eating Peanut Butter?

Paul Kiesel — Tue, 10 Feb 2009 20:05:56 GMT

From CNN:

Peanut butter makers not affected by the deadly salmonella outbreak linked to a Georgia peanut plant are trying to get consumers to keep buying peanut butter. It could be an uphill battle.

J.M. Smucker Co. wants to assure consumers that its Jif brand of peanut butter is safe to eat.

Companies such as ConAgra Foods Inc. and J.M. Smucker Co. have started running ads and offering coupons, trying to lure peanut butter customers as sales have plunged at least 20 percent since the salmonella outbreak.

Eight people have died and nearly 600 have been sickened in the outbreak. The original peanut butter recall launched weeks ago has expanded to include more than 1,000 products.

On ConAgra's Web site, a letter assures customers that the company's peanut butter is safe.

"ConAgra Foods, the maker of Peter Pan Peanut Butter, has confirmed that none of the ingredients used to make Peter Pan Peanut Butter come from Peanut Corporation of America, the company linked to the government's current salmonella investigation," the letter says. "We are extremely confident in the safety protocols."

J.M. Smucker, maker of Jif peanut butter, had a similar message for customers.

"Our Smucker's peanut butter brand and peanut butter products are safe for consumption. The J.M. Smucker Company does not purchase peanuts or any ingredients from Peanut Corporation of America," its Web site says.

The Peanut Corporation of America is under investigation by the Food and Drug Administration, and the FBI searched its Blakely, Georgia, plant on Monday, CNN affiliate WALB-TV in Albany, Georgia, reported.

Americans have shied away from peanut butter despite the FDA's assurances that major-label peanut butter in grocery stores is safe.

With eight dead and almost 600 sick [. . .]

For the rest of the article, click here.

Originally posted at InjuryBoard by Paul Kiesel

Ethex Expands Recent Recall Even Further

Paul Kiesel — Thu, 05 Feb 2009 20:37:09 GMT

From Forbes:

Associated Press - KV Pharmaceutical Co. is issuing its fourth product recall in about three months because some of its prescription prenatal and iron supplements were made under unsatisfactory conditions.

Late Tuesday, KV said it is voluntarily pulling dozens of prescription iron supplements and prenatal vitamin capsules and tablets because the products were made under conditions that didn't comply with industry standards. The recall includes products made by its Ther-Rx and Ethex divisions.

The company also extended a recall of five drugs made by Ethex, KV's generic business. Those drugs, along with dozens of others, were recalled last week at the wholesale level because of manufacturing problems. The new recall extends to the retail level.

In afternoon trading, KV shares lost 10 cents, or 13.9 percent, to 62 cents.

KV has issued four spates of product recalls since Nov. 7, citing manufacturing problems and accidentally oversized pills. On Jan. 26, the company recalled most of its products, and stopped its manufacturing and shipping operations. It warned that the Food and Drug Administration might choose to investigate or file charges.

Originally posted at InjuryBoard by Paul Kiesel

Digitek Digoxin Recall

Paul Kiesel — Mon, 12 May 2008 13:00:36 GMT

On April 28, 2008 the Food and Drug Administration (FDA) issued a recall on all Digitek (digoxin) tablets, which may contain twice the approved level of digoxin. The existence of double-strength pills pose a risk of digitalis toxicity, which can result in nausea, vomiting, low blood pressure, cardiac instability, bradycardia and even death. KBL is currently investigating the death of a Southern California heart patient who was taking one of the recalled lots distributed by Mylan Pharmaceuticals, Inc. The recalled digoxin tablets, Digitek, is a registered trademark of Actavis Totowa (formerly Amide Pharmaceutical, Inc.

Originally posted at InjuryBoard by Paul Kiesel

Odor Reports Prompt Tylenol Recall

Chrissie Cole — Wed, 29 Jun 2011 10:37:00 GMT

Odor reports have prompted the voluntary recall of one lot of TYLENOL, Extra Strength Caplets in the U.S. The affected products were manufactured in February 2009.

McNeil is taking this measure following reports of odor reports including moldy, musty odor which has been linked to a trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).

TBA has been associated with temporary and non-serious gastrointestinal symptoms.

The recall involves the following lot of Tylenol:

TYLENOL, Extra Strength Caplets, 225 Count – Lot # ABA619 – UPC Code: 300450444271

Consumers are urged to discontinue use of this product if it is subject to the recall. Contact McNeil by visiting www.tylenol.com or by calling 1-888-222-6036 for information about a refund or product coupon.

Medical questions and concerns should be directed to your medical doctor. To report adverse reactions, use the FDA’s MedWatch program online or by mail.

Originally posted at InjuryBoard by Chrissie Cole

Recall Of Certain Salad Mixes Issued By Garden State Due To Listeria Risk

Chrissie Cole — Tue, 25 Jan 2011 12:01:00 GMT

A voluntary recall of all Salad products has been issued by State Garden, due to potential contamination with Listeria monocytogenes.

Listeria monocytogenes can cause serious and sometimes fatal infections in young children, elderly people, and others with weakened immune systems.

The Salad Products and Blends involved in this recall were sold under several brand names including: Gold Quality, Hannaford, Natures Place, Natures Promise, Roche Bros, Northeast Fresh, Noreast Fresh, Olivia’s Organics, Signature and Wegmans.

The FDA Web site includes a detailed list of specific salad product, size, package type and UPC codes.

The trace back code numbers (45693 and 45703) can be found in the upper right hand corner of the bags and labels. The “best if used by” date is no later than Jan. 15, 2011.

This product should not be consumed. It should be returned to the place of purchase for a refund. For more information on this recall call 1-888-841-6191.

No other Garden State products are affected by this recall.

Originally posted at InjuryBoard by Chrissie Cole