“NEW DIET DRUG HELPS PATIENTS LOSE ABOUT 10% OF WEIGHT”
USAToday reports on the FDA’s recent approval of QYSMIA to combat obesity. The video above highlights the claimed benefits of the newest “weight-loss” pill that will soon be available to millions combating obesity. It was previously known as QNEXA and did not gain FDA approval under that name when originally considered. At the time, experts were concerned over added risks associated with heart rates. QYSMIA is intended for individuals that are obese, or 30 pounds over their target weight.
Health experts are already cautioning that the pills will not be a ‘magic pill’ that produces results. Rather, as W. Timothy Garvy, Chair of the Department of Nutrition Sciences at the University of Alabama-Birmingham, is quoted as stating, in USAToday:”This is not a magic pill. Patients can’t take it and think that’s all they have to do. It needs to be used with a lifestyle modification program”.
Public Citizen’s Sidney Wolfe has already been outspoken about the newly approved pill and is quoted as stating that it was “reckless” of the FDA to approve it because research has demonstrated it increases heart rate and at least 4 patients taking the pill had non-fatal heart attacks during the research phase.
USAToday reports that post-market surveillance on cardiovascular outcomes is planned but that results will not breadh for 4-5 years. QSYMIA is expected on shelves by the end of 2012.
Glaxo Smith Kline, or #GSK, recently agreed to pay $3 Billion Dollars in a record setting investigation by the Department of Justice (DOJ). The settlement centered around a number of questionable, and allegedly illegal business practices, in the promotion of a number of pharmaceutical products. This was an Exhibit in the DOJ investigation.
Cruises, Pheasant Hunting Trips, and Political Donations: The 5 Skeeziest GlaxoSmithKline Perks Revealed
PROPECIA and MERCK have been linked to alleged claims of sexual dysfunction in users. Lawsuits have been filed and MERCK continues to deny a scientific correlation between the claimed injuries and use of their product.
We are actively investigating cases involving use of PROPECIA and sexual dysfunction in young men who used the product for male pattern baldness. Contact requests may be sent thru a contact form from here.
In late June 2012, the U.S. Food & Drug Administration (“FDA”) held hearings over the course of 2 days to consider growing concerns and evidence relating to Metal on Metal (MoM) hip implants, resurfacing devices and other issues.
While most Americans celebrated mid-week July 4th, #STRYKER, a major manufacturer of hip implants announced that it was #recalling a failing component in its line of modular hip implants. By July 6th, PR releases from the company entitled “Stryker Initiates Voluntary Product Recall of Modular-Neck Stems, Action Specific to Rejuvenate and ABG II Modular-Neck Stems” announed that post-market surveillance had revealed potential risks of fretting and corrosion at the modular neck junction. This means that part of the joint, a stem like area that joined other components was failing and leading to serious complications and potential health risks for patients.
The image above is from Recall Attorneys / Recall Lawyers on Facebook. All of the surrounding PR and little news that has been publicized over this #recall highlights the fact that noone is putting a number on how many failed modular neck stems were manufactured, sold or implanted. Wonder if that is a deliberate failure on the part of #Stryker, or is it indicative of the fact that noone really knows. Until the dust settles on this #recall noone will know. Lawsuits related to the failure are imminent as patient advocates circle the wagons to seek answers and redress.
Additional information on existing Joint Recalls and related the ongoing investigation of the failure rate surrounding the previously recalled DePuy ASR, and now the Stryker Rejuvenate and ABG II Modular Neck Stems is available by contacting the sponsor of this site here.
The #NUVARING is a fairly new option in contraception or birth control. It is not an #IUD which is medically inserted and left in place for 5 or more years at a time. Rather, it is inserted in the vagina and designed to inhibit reproduction by releasing hormones. Hormonal contraceptive pills, or oral contraceptives, release a combination of hormones to inhibit reproduction or prevent pregnancy.
In April 2012, the FDA announced that one of the most popular family of oral contraceptives - #YASMIN #YAZ #BEYAZ #SAFYRAL and their generic equivalents #GIANVI #OCELLA #ZARAH #SYEDA - would carry warnings of increased risk of blood clots. A month later, the British Medical Journal released the findings of a new study that evaluated similar risks from use of #NUVARING. The study entitled, “VENOUS THROMBOSIS IN USERS OF NON-HORMONAL CONTRACEPTION: FOLLOW UP STUDY, DENMARK 2001-10”, by O. Lidegaard, L. Hougaard, C. Wessel Skovlund and E. Lokkegaard, analyzed data to conclude that “[w]omen who use combined hormonal transdermal patches or vaginal rings for contraception have a 7.9 times or 6.5 times increased risk of venous thrombosis compared with non-users of hormonal contraception of the same age”. The authors further concluded that, “the vaginal ring conferred 90% higher risk of venous thrombosis than did combined oral contraceptives containing levonorgestrel, bringing the risk to the same level as that of combined oral contraceptives with third and fourth generation” progestins. This was interpreted as confirming the October 2011 findings of an FDA funded study evaluating the vaginal ring and #DROSPIRENONE (#DRSP) containing birth control. They concluded that women who wanted to use a hormonal contraceptive should be advised to use combined oral contraceptives with levonorgestrel or norgestimate, rather than transdermal patches or vaginal rings.
Vaginal rings, like #NUVARING, increased the risk of venous thrombosis 6.5 times compared with non-use of hormonal contraception. Whether this study, and FDA’s study of October 2011, will prompt additional investigations, warnings or a #recall remains to be seen. At the time, in October 2011, the FDA admitted that with regard to both #DROSPIRENONE and #NUVARING there was little data available for adverse outcomes. Is that comforting to you? With regard the NUVARING, the FDA noted that the increase risk of blood clots was “new” and raised concerns that needed to be replicated in other studies. From my reading, the BMJ study further underscores concerns and may hopefully prompt some regulatory action.
Ironically, the BMJ study was released just before National Women’s Health Week but neither the FDA, nor news media highlighted the study or similar findings FDA’s own study confirmed in October 2011. Whether women were adequately warned of increased risks prior to use is the question posed by a growing number of lawsuits over use of the #NUVARING. The latest study appears to demonstrate a higher risk, no more benefit and raise questions about what the manufacturer knew and when.
Gabriel F. Zambrano, P.A., is the author and sponsor of this commentary. Gabriel F. Zambrano, P.A., is actively representing victims of #DROSPIRENONE containing birth control pills discussed here. Gabriel F. Zambrano, P.A., is investigating #NUVARING cases involving blood clots or complications from blood clots including: Strokes, Cardiac Infarct, Deep Vein Thrombosis, Pulmonary Emboli, Arterial Thromboembolic Events and other life altering injuries.
“Blood Clot Warning Added to Yaz and Other Newer Birth Control Pills
April 11, 2012 | By Alexandra Sifferlin | 1
Harrison Eastwood / Getty Images
Yaz, Yasmin and other newer birth control pills will soon be bearing warning labels that detail the potential risk of blood clot risks, the U.S. Food and Drug Administration (FDA) announced on Tuesday.
The FDA is updating the labels based on recent studies that suggest that birth control pills containing drospirenone, a synthetic version of the female hormone progesterone, have a slightly increased risk of blood clots, compared with older birth control pills.
(MORE: Caution Ladies: More Birth Control Pills Recalled)
The new labels will note that some studies have found as high as a threefold increase in the risk of blood clots with drospirenone-containing pills, and will include a summary of a previous FDA-funded study on the risk, officials said in a statement.
However, the overall risk of blood clots on either newer or older birth control pills is still very low. In its statement, the FDA put the risk into perspective:
The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period…For example: If 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot.
Popular birth control brands Beyaz, Safyral, Yasmin and Yaz will all receive the updated labels, but the FDA says women already using them shouldn’t worry and should “continue taking their pills as directed unless told otherwise by their healthcare professional.”
(VIDEO: Nancy Gibbs on the Pill’s Importance)
The FDA does suggest that women educate themselves on symptoms of blood clots, including persistent leg pain, severe chest pain and sudden shortness of breath. If women experience these symptoms, they should call their doctor right away.”
Following the convening of a joint panel of experts on 12.8.11 to discuss multiple independent studies related to the DRSP (DROSPIRENONE) family of contraceptives, on 4.10.12 the U.S. Food & Drug Administration issued the “FDA DRUG SAFETY COMMUNICATION” below. This communication has been reported in related news stories and “PR” from the manufacturer, BAYER HEALTHCARE PHARMACEUTICALS in a fashion that downplays the serious risk that this family of contraceptives, and their generic equivalents present to users. Moreover, the history of these pills, FDA sanctions against the manufacturer, over 11,000 pending civil lawsuits, allegations of “conflicts of interest” in the 12.8.11 Ad Comm Meeting, as well as testimony from Former FDA Commissioner D. Kessler regarding missing or hidden data is being complete ignored in recent reports. More information on the above and YAZ CLAIMS is available here YAZ RECALL.
FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone
This update is in follow-up to the FDA Drug Safety Communication posted on 9/26/11: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone.
[4-10-2012] The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills. See Table 1 for a list of drospirenone-containing products.
Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.
Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.
The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not. The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills.
The revised drug labels (Beyaz, Safyral, Yasmin and Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.
To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period.
These studieswere discussed at the joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. FDA’s briefing document for this meeting is found here.
Previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone were posted on May 31, 2011, September 26, 2011, and October 27, 2011. The DSC posted in May 2011 updated the public about FDA’s ongoing safety review of two new studies that reported a greater risk of blood clots for women taking drospirenone-containing products as compared to the risk in women taking products containing other progestins. Previously published studies had reported conflicting findings. The DSC posted in September 2011 discussed preliminary results from a FDA-funded study suggesting an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing products compared to users of other hormonal contraceptives. The DSC posted in October 2011 released the final study report and appendices from the FDA-funded study in advance of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting.
Today’s communication is in keeping with FDA’s commitment to inform the public about the Agency’s ongoing safety review of drugs. FDA will communicate any new information on drospirenone-containing birth control pills and the risk of blood clots when it becomes available.
For more information: http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm
PHARMALOT’S, Ed Silverman, from the Publishers of PharmaLive.com, examines the state of DRSP (DROSPIRENONE) birth control and the FDA Advisory Committee hearings of 12.8.11.
“Three months ago, an FDA advisory panel voted 15-to-11 that the benefits of the Yaz and Yasmin birth control pills outweigh the risks, and the drugs should remain on the market, albeit with added information about a risk of blood clots. The decision followed a long-running controversy - studies by Bayer, which sells the pills, found there is no risk, while other studies said risk is evident (see this).
But controversy also surrounded the meeting. Beforehand, the FDA yanked Sid Wolfe of the Public Citizen Health Research group from the panel due to an intellectual conflict of interest (read here). Afterwards, concerns were raised because four panel members held ties to Bayer, either as paid consultants or in the form of research funding, but the FDA did not disclose the conflicts, prompting the Project on Government Oversight, a watchdog group, to ask the FDA to convene an entirely new meeting (read this and this).
Now, a coalition of women’s health groups charges there were several irregularities that may well have altered the outcome. In a letter to FDA commish Margaret Hamburg, the coalition complains, in particular, that the key question panelists had to answer, which determined the outcome of the voting, was vague and confusing. And they maintain that several panelists who are practicing obstetricians and gynecologists may also have held intellectual conflicts that swayed their votes.
“Obviously, we can’t predict how people would have voted with different wording…,” the coalition wrote. “However, the vaguely (and, we believe, inappropriately) worded question and the difference in how conflicts of interest were handled raises very serious questions of bias.” The groups that signed the March 9 letter include the Jacobs Institute of Women’s Health, the National Research Center for Women & Families, the National Women’s Health Network and Our Bodies Ourselves.
The panelists were asked to vote on whether “the benefits of the DRSP-containing oral contraceptives for prevention of pregnancy outweigh their risks.” DRSP is drospirenone, which is a hormone contained in the Yaz and Yasmin pills. After voting, each panelist was asked to explain their vote, and the coalition noted that those who voted “no” explained that safer oral contraceptives were available.
However, the letter also notes that almost all of the 15 who voted “yes” indicated they voted on a comparison of risks and benefits compared to pregnancy, rather than on whether the risks and benefits of oral contraceptives containing DRSP outweigh risks and benefits compared to other oral contraceptives. These are two different issues, the coalition writes, the befuddled some panelists.
The coalition pointed to panelist Elaine Morrato, who voted “yes,” but said: “However, if the standard is to make a comparative, which… I just compared it in the absolute sense. I would agree that I didn’t see any benefit of the product that’s well demonstrated for Yasmin, perhaps for Yaz. And so if the regulatory standard would be that you’d have to demonstrate a comparative benefit, then I would vote no.” This would have changed the vote to 14-to-12.
Another panelist, Anne Burke, voted “yes,” and according to the letter, said: “I don’t think I was expecting it to be more effective than other pills on the market, and while I acknowledge that there does seem to be a moderate increased risk, it’s still lower than the risks of pregnancy. And like some other folks who have spoken, a no vote sounded like it would be - to take the product off the market. I’m not quite sure that’s necessary at this point.”
And panelist Julia Johnson voted “yes” and said: “I am significantly concerned regarding the most recent FDA study…I would like to see comparison with another U.S. study. I think that’s absolutely critical. I do not think there is one advantage for this pill over any other for use for women. If indeed there is truly an increased risk, then I would vote differently,” according to the letter. Both Johnson and Burke had ties to Bayer.
Meanwhile, seven other panelist are practicing OB/GYNs. “Given that practicing OB/GYNs routinely prescribe oral contraceptives, and that these physicians have likely made a decision to either prescribe or not prescribe/stop prescribing DRSP-containing OCs prior to the meeting, this certainly raises an intellectual conflict of interest as great as that attributed to Dr. Wolfe. Had they been ask to participate in the panel but not vote, as Dr. Wolfe was, this clearly would have resulted in a majority vote that the benefits do not outweigh the risks,” the coalition writes to Hamburg.
How so? Here is the math: If Wolfe voted no and at least one of the three panelist who expressed strong concerns voted “no” on the more specific question of whether the benefits outweigh the risks compared to other pills, the vote would have been 14 “no” and 13 “yes.” But if Wolfe and those with a financial conflict had not been allowed to vote, the final vote would have been 11-to-11. And if Morrato had been counted as a “no,” given her confusion, then the vote would have 12-to-10 against allowing the Bayer drugs to remain on the market, the coalition writes (here is the letter).
The coalition, however, stopped short of asking the FDA to hold a new meeting and, instead, wants Hamburg to review its policies “that resulted in biases” so a repeat does not occur. We asked the FDA, which previously indicated the POGO request for a new meeting would be reviewed, for a reply and will update you accordingly. [UPDATE: An FDA spokeswoman writes us to say the agency will respond directly to the coalition.]”